{"source":"https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters","fetched":"2026-11-11","taxonomy":{"version":1,"categories":[{"id":"risk_omission","label":"Omits or minimizes risk","definition":"FDA says the piece leaves out, plays down or contradicts a warning, contraindication, boxed warning or side effect, or that it creates a misleading impression of the drug's safety."},{"id":"risk_presentation","label":"Risk not clear and conspicuous","definition":"The risk information is there, but FDA says it is not presented in a clear, conspicuous and neutral manner: the major statement, fair balance, prominence, readability, dual audio and text, competing visuals, small or fast text."},{"id":"efficacy_claims","label":"Overstated or unsupported efficacy","definition":"Claims about effectiveness or benefit that go beyond or misrepresent the evidence: misleading use of study data, endpoints or statistics, mechanism of action, durability, quality-of-life or patient-reported outcomes, or claims with no substantial evidence behind them."},{"id":"superiority","label":"Unsupported superiority or comparison","definition":"Claims that the drug is better, safer, faster, more effective or preferred compared with another treatment without adequate head-to-head evidence."},{"id":"broader_use","label":"Broader use than approved","definition":"Suggests use in patients, conditions, doses, settings or product forms FDA has not approved, or promotes a drug that is not yet approved (investigational or preapproval promotion)."},{"id":"dosing_convenience","label":"Misleading dosing or convenience","definition":"Misleading claims about dosing, administration, onset of action, convenience, adherence, or how quickly or easily the drug works in practice."},{"id":"missing_disclosure","label":"Missing required disclosure","definition":"A required element is absent: the indication, the established name, the brief summary or full prescribing information, the boxed warning statement, or the adequate-provision information required for the format."},{"id":"form_2253","label":"Not submitted on Form 2253","definition":"FDA says the piece was not submitted at the time of first dissemination, as 21 CFR 314.81(b)(3)(i) or 601.12(f) requires."}],"channels":[{"id":"tv_ad","label":"TV ad"},{"id":"radio_ad","label":"Radio ad"},{"id":"print_ad","label":"Print or journal ad"},{"id":"website","label":"Website"},{"id":"email","label":"Email"},{"id":"social_media","label":"Social media post"},{"id":"online_video","label":"Online video"},{"id":"sales_aid","label":"Sales aid or visual aid"},{"id":"brochure","label":"Brochure or leave-behind"},{"id":"exhibit","label":"Conference booth or exhibit"},{"id":"press_media","label":"Press release or media interview"},{"id":"search_ad","label":"Search or display ad"},{"id":"spokesperson","label":"Spokesperson or influencer"},{"id":"speaker_program","label":"Webinar or speaker program"},{"id":"other","label":"Other"}],"audiences":[{"id":"consumer","label":"Consumers (DTC)"},{"id":"professional","label":"Healthcare professionals"},{"id":"both","label":"Consumers and professionals"}]},"letters":[{"id":"u196750","type":"untitled","date":"2026-10-26","company":"Vanda Pharmaceuticals","listedAs":"Vanda Pharmaceuticals, Inc.","brand":"Nereus","generic":"tradipitant","product":"NEREUS™ (tradipitant) capsule, for oral use","appType":"NDA","appNumber":"220152","matter":"15","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer broadcast TV ad (NER0009)","categories":["risk_omission","risk_presentation","broader_use","dosing_convenience"],"quotes":{"broader_use":"This creates the misleading impression that Nereus can be used either after or immediately prior to engaging in activities that could lead to vomiting induced by motion, when this has not been demonstrated.","dosing_convenience":"the TV ad is misleading in respect to timing of administration, as the man is shown taking the capsule immediately prior to jumping on the boat, suggesting instant efficacy.","risk_omission":"the TV ad is misleading because it minimizes the risks associated with Nereus by presenting visuals directly at odds with the information provided in the WARNINGS AND PRECAUTIONS section of the PI.","risk_presentation":"the TV ad fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer TV ad showing a car and motorboat chase. FDA said it implied use after motion begins and instant effect, played down the risk of impaired driving, and showed the major statement without full dual modality and with distracting visuals.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/media/196750/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1739,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"vanda-pharmaceuticals-nereus-2026-10-26"},{"id":"u195157","type":"untitled","date":"2026-09-28","company":"Evolus","listedAs":"Evolus, Inc.","brand":"JEUVEAU","generic":"prabotulinumtoxina-xvfs","product":"JEUVEAU® (prabotulinumtoxinA-xvfs) for injection, for intramuscular use","appType":"BLA","appNumber":"761085","matter":"622","audience":"consumer","channels":["social_media","online_video"],"piece":"Instagram reel post with patient testimonial from Josephine","categories":["risk_omission","risk_presentation","efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"Thus, claims suggesting that frown lines are “gone” or patients experienced “complete” results are not supported.","dosing_convenience":"the post also creates a misleading impression regarding the onset of efficacy.","risk_omission":"the promotional communication creates a misleading impression regarding the safety and effectiveness of Jeuveau","risk_presentation":"the reel fails to present information related to the side effects and contraindications of Jeuveau with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Jeuveau."},"summary":"An Instagram reel and caption with a patient testimonial overstated how much and how fast Jeuveau works using exploratory data, likened the injectable to an everyday beauty product, and placed risk information at the end with little prominence.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/media/195157/download?attachment","promo":[{"url":"https://www.fda.gov/media/195158/download?attachment","format":"MP4"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":2238,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"evolus-jeuveau-2026-09-28"},{"id":"u194514","type":"untitled","date":"2026-08-21","company":"Alar Pharmaceuticals","listedAs":"Alar Pharmaceuticals Inc.","brand":"ALA-3000","generic":"ketamine pamoate","product":"ALA-3000 (ketamine pamoate) injection","appType":"","appNumber":"","matter":"1","audience":"professional","channels":["exhibit","brochure"],"piece":"APA 2026 exhibit booth display and brochure","categories":["risk_omission","efficacy_claims","superiority","broader_use"],"quotes":{"broader_use":"represent, in a promotional context, that ALA-3000, an investigational","efficacy_claims":"The claims are extremely concerning given the lack of adequate safety and efficacy data for","risk_omission":"the representation that ALA-3000 is safe and has none of the concerns associated","superiority":"context that ALA-3000 is different from or superior to approved therapies for treating TRD."},"summary":"An exhibit booth display and brochure at the APA 2026 Annual Meeting promoted investigational ALA-3000 as safe and effective for treatment-resistant depression, claimed it lacked known ketamine risks, and suggested superiority to approved therapies.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/194514/download?attachment","promo":[{"url":"https://www.fda.gov/media/194513/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/194515/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1473,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"alar-pharmaceuticals-ala-3000-2026-08-21"},{"id":"wamgen-inc-739641-08122026","type":"warning","date":"2026-08-12","company":"Amgen","listedAs":"","brand":"Vectibix","generic":"panitumumab","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["online_video"],"piece":"Promotional video USA-954-81023","categories":["risk_omission","broader_use","missing_disclosure"],"quotes":{"risk_omission":"The video is misleading because it includes representations about the benefits of Vectibix but fails to communicate any risk information.","missing_disclosure":"The video is misleading because it fails to provide material information regarding Vectibix’s full FDA-approved indication, including important limitations of use.","broader_use":"The video suggests the use of Vectibix for the general treatment of wild-type RAS mCRC, but does not specify that Vectibix is indicated in specific regimens based on its line in therapy"},"summary":"A promotional video for Vectibix presented benefit claims, such as short infusion time and no premedication, but included no risk information. FDA also said it omitted the full approved indication and its limitations of use.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amgen-inc-739641-08122026","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1614,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"amgen-vectibix-2026-08-12"},{"id":"u194718","type":"untitled","date":"2026-07-28","company":"Travere Therapeutics","listedAs":"Travere Therapeutics, Inc.","brand":"FILSPARI","generic":"sparsentan","product":"FILSPARI® (sparsentan) tablets, for oral use","appType":"NDA","appNumber":"216403","matter":"191","audience":"professional","channels":["sales_aid"],"piece":"Professional visual aid (05/2026 SPA0981 v2)","categories":["risk_omission","efficacy_claims"],"quotes":{"efficacy_claims":"These claims create a misleading impression regarding the benefits of Filspari.","risk_omission":"This claim misleadingly minimizes the risks"},"summary":"A professional visual aid for Filspari claimed kidney preservation and nephroprotection that were not demonstrated, and presented exploratory remission data as proven. FDA also said it minimized the risks of hepatotoxicity and hypotension.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/194718/download?attachment","promo":[{"url":"https://www.fda.gov/media/194719/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1381,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"travere-therapeutics-filspari-2026-07-28"},{"id":"u193721","type":"untitled","date":"2026-07-15","company":"Sanofi","listedAs":"Sanofi Vaccines US Inc.","brand":"BEYFORTUS","generic":"nirsevimab-alip","product":"BEYFORTUS® (nirsevimab-alip) injection, for intramuscular use","appType":"BLA","appNumber":"761328","matter":"745","audience":"professional","channels":["email"],"piece":"Professional emails MAT-US-2514195-1 and MAT-US-2514837-1","categories":["broader_use"],"quotes":{"broader_use":"they suggest the use of Beyfortus for the general prevention of Respiratory Syncytial Virus (RSV), including both upper and lower respiratory tract disease, when this is not the case."},"summary":"Two professional emails for Beyfortus suggested it is for general RSV prevention, including upper respiratory tract disease. FDA said this misrepresented the approved indication, which is limited to RSV lower respiratory tract disease.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/193721/download?attachment","promo":[{"url":"https://www.fda.gov/media/193720/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/193719/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":766,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"sanofi-beyfortus-2026-07-15"},{"id":"u193722","type":"untitled","date":"2026-07-13","company":"Viatris Specialty","listedAs":"Viatris Specialty LLC","brand":"TOBI PODHALER","generic":"tobramycin inhalation powder","product":"TOBI® PODHALER® (tobramycin inhalation powder), for oral inhalation use","appType":"NDA","appNumber":"201688","matter":"931","audience":"consumer","channels":["online_video","spokesperson"],"piece":"DTC video 'Jax's Experience with the TOBI PODHALER'","categories":["dosing_convenience"],"quotes":{"dosing_convenience":"These claims create the misleading impression that patients can perform the administration process for TOBI Podhaler anywhere, such as “in the car” or “while running out of the door on the way to school,” without concern."},"summary":"A direct-to-consumer video featuring a patient and parent described using TOBI Podhaler anywhere, such as in the car. FDA said this misleadingly implied administration is easy anywhere, despite detailed Instructions for Use steps and moisture-sensitive handling that affect dosing.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/193722/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1001,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"viatris-specialty-tobi-podhaler-2026-07-13"},{"id":"u193472","type":"untitled","date":"2026-06-24","company":"Lundbeck","listedAs":"Lundbeck Seattle Biopharmaceuticals, Inc.","brand":"Vyepti","generic":"eptinezumab-jjmr","product":"VYEPTI® (eptinezumab-jjmr) injection, for intravenous use","appType":"BLA","appNumber":"761119","matter":"684","audience":"professional","channels":["website"],"piece":"HCP website 'Efficacy and 2-year patient outcomes' and 'Real VYEPTI experience' webpages","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These claims and presentations create the misleading impression that patients treated with Vyepti will be 100% migraine-free for a month or more, when this has not been demonstrated."},"summary":"Two webpages on the Vyepti healthcare provider website presented post-hoc, open-label and observational study data. FDA said they misleadingly suggested 100% migraine freedom and benefits on patient-reported outcomes such as disability, quality of life, good days and brain fog.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/193472/download?attachment","promo":[{"url":"https://www.fda.gov/media/193470/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/193471/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":2153,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"lundbeck-vyepti-2026-06-24"},{"id":"u193307","type":"untitled","date":"2026-06-22","company":"Pinnacle Biologics","listedAs":"Pinnacle Biologics, Inc.","brand":"PHOTOFRIN","generic":"porfimer sodium","product":"PHOTOFRIN® (porfimer sodium) for injection, for intravenous use","appType":"NDA","appNumber":"020451","matter":"183","audience":"professional","channels":["online_video"],"piece":"Esophageal Cancer and NSCLC mechanism-of-action videos","categories":["risk_omission","risk_presentation","efficacy_claims","missing_disclosure"],"quotes":{"missing_disclosure":"By failing to adequately disclose the full indications associated with Photofrin, the videos create a misleading impression about the drug’s FDA-approved indications.","risk_omission":"By omitting risks associated with Photofrin, the videos fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety.","risk_presentation":"they fail to present information relating to the serious risks and side effects associated with Photofrin with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug.","efficacy_claims":"Therefore, these conclusory claims and presentations (i.e., “proven”) are misleading."},"summary":"Two mechanism-of-action videos for Photofrin aimed at healthcare providers omitted full indications, contraindications and serious warnings. They presented risk information with little prominence, minimized risks, and made unsupported claims about anti-tumor immunity and tumor destruction.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/193307/download?attachment","promo":[{"url":"https://www.fda.gov/media/193308/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/193309/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1919,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"pinnacle-biologics-photofrin-2026-06-22"},{"id":"u192843","type":"untitled","date":"2026-05-26","company":"QOL Medical","listedAs":"QOL Medical, LLC.","brand":"Sucraid","generic":"sacrosidase","product":"SUCRAID® (sacrosidase) oral solution","appType":"BLA","appNumber":"020772","matter":"553","audience":"consumer","channels":["email"],"piece":"Promotional emails for Sucraid","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"The emails omit material facts regarding the risks associated with Sucraid.","risk_presentation":"the presentation of risk information in the emails do not appear in a sequence that discloses risk information in order of severity, and thus misleadingly minimizes the risks associated with Sucraid"},"summary":"Promotional emails for Sucraid left out material risk information from the prescribing information, including severe hypersensitivity reactions, increased blood glucose in diabetes and the need for dietary starch restriction. They also presented risks out of order of severity, which minimized them.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/192843/download?attachment","promo":[{"url":"https://www.fda.gov/media/192844/download?attachment","format":"PDF"}],"closeoutDate":"2026-07-23","closeoutUrl":"https://www.fda.gov/media/193893/download?attachment","closeoutKnown":true,"closeoutDays":58,"words":643,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"qol-medical-sucraid-2026-05-26"},{"id":"u192467","type":"untitled","date":"2026-05-12","company":"BeOne Medicines","listedAs":"BeOne Medicines USA, Inc.","brand":"BRUKINSA","generic":"zanubrutinib","product":"BRUKINSA® (zanubrutinib) capsules and tablets, for oral use","appType":"NDA","appNumber":"218785","matter":"38","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (0525-BRU-PRC-138)","categories":["risk_presentation","efficacy_claims","superiority"],"quotes":{"efficacy_claims":"results from these PROs do not support the suggestion that patients on Brukinsa will “see their futures clearly” by improving their quality of life.","superiority":"The totality of these claims and presentation misleadingly suggests that Brukinsa has a superior safety profile","risk_presentation":"the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer TV ad for Brukinsa. FDA said it misleadingly implied quality-of-life benefits and a superior cardiovascular safety profile versus ibrutinib, and that its major statement lacked dual modality and was undercut by distracting visuals.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/192467/download?attachment","promo":[],"closeoutDate":"2026-06-16","closeoutUrl":"https://www.fda.gov/media/195780/download?attachment","closeoutKnown":true,"closeoutDays":35,"words":1286,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"beone-medicines-brukinsa-2026-05-12"},{"id":"u192241","type":"untitled","date":"2026-04-28","company":"Bayer HealthCare Pharmaceuticals","listedAs":"Bayer HealthCare Pharmaceuticals, Inc.","brand":"NUBEQA","generic":"darolutamide","product":"NUBEQA® (darolutamide) tablets, for oral use","appType":"NDA","appNumber":"212099","matter":"997","audience":"consumer","channels":["online_video","tv_ad"],"piece":"DTC YouTube video and Spanish-language TV ad","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"The video and TV ad are misleading because they include claims and representations about the benefits of Nubeqa but omit important risk information associated with the drug.","risk_presentation":"the video and TV ad are misleading because they fail to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer YouTube video and a Spanish-language TV ad for Nubeqa left out important heart disease and seizure risk information. FDA also said the major statement lacked dual modality and was undercut by distracting visuals.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/192241/download?attachment","promo":[],"closeoutDate":"2026-06-09","closeoutUrl":"https://www.fda.gov/media/193054/download?attachment","closeoutKnown":true,"closeoutDays":42,"words":867,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bayer-healthcare-pharmaceuticals-nubeqa-2026-04-28"},{"id":"u192265","type":"untitled","date":"2026-04-23","company":"Alnylam Pharmaceuticals","listedAs":"Alnylam Pharmaceuticals, Inc.","brand":"AMVUTTRA","generic":"vutrisiran","product":"AMVUTTRA® (vutrisiran) injection, for subcutaneous use","appType":"NDA","appNumber":"215515","matter":"352","audience":"consumer","channels":["website"],"piece":"\"ATTR-CM\" webpage on the AMVUTTRA Consumer Website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The totality of the claims and presentations above creates a misleading impression that treatment with Amvuttra has shown a definitive and quantified benefit, with specific established levels of efficacy, on mortality over 3½ years, when this is not the case."},"summary":"A consumer webpage for Amvuttra claimed patients with ATTR-CM lived longer, citing quantified 3.5-year mortality and survival results. FDA said these claims relied on an open-label extension without a concurrent control and overstated a definitive mortality benefit.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/192265/download?attachment","promo":[{"url":"https://www.fda.gov/media/192271/download?attachment","format":"PDF"}],"closeoutDate":"2026-08-24","closeoutUrl":"https://www.fda.gov/media/194887/download?attachment","closeoutKnown":true,"closeoutDays":123,"words":1295,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"alnylam-pharmaceuticals-amvuttra-2026-04-23"},{"id":"u192125","type":"untitled","date":"2026-04-22","company":"Incyte","listedAs":"Incyte Corporation","brand":"Niktimvo","generic":"axatilimab-csfr","product":"NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use","appType":"BLA","appNumber":"761411","matter":"91","audience":"consumer","channels":["website"],"piece":"DTC website landing page and 'Responses' webpage","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"These claims misleadingly overstate the efficacy of Niktimvo by suggesting that Niktimvo has demonstrated complete responses in patients with chronic graft-versus-host disease (cGVHD), when this is not the case.","dosing_convenience":"First, these claims and presentations misleadingly suggest that patients will experience a “fast” response to the drug, when this is not the case."},"summary":"The landing page and Responses webpage of the Niktimvo consumer website were reviewed. FDA objected that they overstated efficacy by implying complete, fast and lasting responses, organ-specific benefit, and a reduction in the number of chronic GVHD symptoms.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/192125/download?attachment","promo":[{"url":"https://www.fda.gov/media/192126/download?attachment","format":"PDF"}],"closeoutDate":"2026-05-21","closeoutUrl":"https://www.fda.gov/media/192671/download?attachment","closeoutKnown":true,"closeoutDays":29,"words":1632,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"incyte-niktimvo-2026-04-22"},{"id":"u191932","type":"untitled","date":"2026-04-08","company":"Pfizer","listedAs":"Pfizer, Inc","brand":"ADCETRIS","generic":"brentuximab vedotin","product":"ADCETRIS® (brentuximab vedotin) for injection, for intravenous use","appType":"BLA","appNumber":"125388","matter":"919","audience":"consumer","channels":["social_media","online_video"],"piece":"ADCETRIS PTCL Facebook Ads Set video ads","categories":["risk_omission","broader_use"],"quotes":{"broader_use":"These claims suggest the use of Adcetris for the general treatment of T-cell lymphoma or “certain” previously untreated CD30-expressing peripheral T-cell, but they do not specify the subtypes noted above.","risk_omission":"By omitting this material risk information, the Facebook ads minimize Adcetris’s risks and create a misleading impression of the drug’s safety."},"summary":"A set of Facebook video ads for Adcetris suggested it was for T-cell lymphoma generally without naming the approved subtypes. FDA also said the ads left out the bleomycin contraindication and fatal outcomes from serious infections, skin reactions and hyperglycemia.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191932/download?attachment","promo":[{"url":"https://www.fda.gov/media/191933/download?attachment","format":"PDF"}],"closeoutDate":"2026-04-29","closeoutUrl":"https://www.fda.gov/media/192267/download?attachment","closeoutKnown":true,"closeoutDays":21,"words":1007,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"pfizer-adcetris-2026-04-08"},{"id":"u191883","type":"untitled","date":"2026-03-31","company":"Amneal Pharmaceuticals","listedAs":"Amneal Pharmaceuticals LLC","brand":"ALYMSYS","generic":"bevacizumab-maly","product":"ALYMSYS® (bevacizumab-maly) injection, for intravenous use","appType":"BLA","appNumber":"761231","matter":"65","audience":"consumer","channels":["brochure"],"piece":"Direct-to-consumer patient brochure (PP-PAT-ALYMS-US-0003)","categories":["risk_omission","risk_presentation","superiority","broader_use"],"quotes":{"broader_use":"This misleadingly suggests that Alymsys can be used generally in different cancer types or as a single agent, when this is not the case.","risk_omission":"The patient brochure is misleading because it fails to disclose material risk information regarding the serious risks associated with Alymsys.","risk_presentation":"by not presenting risk information in a sequence that discloses risk information in the order of severity","superiority":"Therefore, representations or suggestions that Alymsys is safer or more effective than Avastin are misleading."},"summary":"A direct-to-consumer patient brochure for Alymsys left out key parts of its approved indications and implied broad or single-agent use. FDA also said it omitted and minimized serious risks, and suggested Alymsys is safer or more effective than Avastin.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191883/download?attachment","promo":[{"url":"https://www.fda.gov/media/191882/download?attachment","format":"PDF"}],"closeoutDate":"2026-04-24","closeoutUrl":"https://www.fda.gov/media/192164/download?attachment","closeoutKnown":true,"closeoutDays":24,"words":1764,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"amneal-pharmaceuticals-alymsys-2026-03-31"},{"id":"u191875","type":"untitled","date":"2026-03-27","company":"BioCorRx Pharmaceuticals","listedAs":"BioCorRx Pharmaceuticals Inc.","brand":"LUCEMYRA","generic":"lofexidine","product":"LUCEMYRA® (lofexidine) tablets, for oral use","appType":"NDA","appNumber":"209229","matter":"228","audience":"consumer","channels":["website"],"piece":"Homepage of the Lucemyra consumer website","categories":["risk_presentation","superiority","form_2253"],"quotes":{"superiority":"This claim misleadingly suggests that Lucemyra is \"the only FDA-approved, non-opioid medicine proven to help with symptoms of opioid withdrawal,\" when this is not the case.","risk_presentation":"fails to present information relating to side effects associated with the drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug","form_2253":"A copy of the webpage was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required."},"summary":"The homepage of the Lucemyra consumer website falsely claimed Lucemyra was the only FDA-approved non-opioid medicine for opioid withdrawal symptoms. It also gave risk information less prominence than benefit claims, and it was not submitted on Form FDA-2253.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/191875/download?attachment","promo":[{"url":"https://www.fda.gov/media/191876/download?attachment","format":"PDF"}],"closeoutDate":"2026-06-29","closeoutUrl":"https://www.fda.gov/media/193445/download?attachment","closeoutKnown":true,"closeoutDays":94,"words":861,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"biocorrx-pharmaceuticals-lucemyra-2026-03-27"},{"id":"wimmunitybio-inc-725468-03132026","type":"warning","date":"2026-03-13","company":"ImmunityBio","listedAs":"","brand":"ANKTIVA","generic":"nogapendekin alfa inbakicept-pmln","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["tv_ad","online_video","spokesperson"],"piece":"DTC TV ad and podcast 'Is the FDA BLOCKING Life Saving Cancer Treatments?'","categories":["risk_omission","risk_presentation","efficacy_claims","broader_use","missing_disclosure","form_2253"],"quotes":{"efficacy_claims":"the representations in the TV ad and podcast misleadingly suggest that Anktiva will allow all NMIBC patients treated with Anktiva to be cancer-free for the long term, when this has not been demonstrated.","broader_use":"Anktiva is not approved as a treatment for “all cancers” or lung cancer after failure of checkpoint inhibitors, nor is it approved for any form of cancer prevention.","risk_presentation":"The overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Anktiva.","risk_omission":"By omitting risk information associated with Anktiva, the podcast fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety.","missing_disclosure":"The TV ad and podcast are misleading because they fail to provide material information regarding Anktiva’s full FDA-approved indication.","form_2253":"A copy of the podcast was not submitted to FDA under cover of Form FDA 2253 at the time of initial publication or dissemination as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A consumer TV ad and a podcast featuring ImmunityBio's executive chairman promoted Anktiva. FDA cited overstated efficacy and cure claims, unapproved uses and routes, risk information that was missing or minimized, an incomplete indication, and failure to submit the podcast at first publication.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/immunitybio-inc-725468-03132026","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":3095,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"immunitybio-anktiva-2026-03-13"},{"id":"u191387","type":"untitled","date":"2026-02-26","company":"Novo Nordisk","listedAs":"Novo Nordisk Inc.","brand":"OZEMPIC","generic":"semaglutide","product":"OZEMPIC® (semaglutide) injection, for subcutaneous use","appType":"NDA","appNumber":"209637","matter":"1457","audience":"consumer","channels":["online_video"],"piece":"DTC video 'Ozempic vs. – Random Guy OLV'","categories":["risk_presentation","efficacy_claims","superiority","broader_use"],"quotes":{"efficacy_claims":"The video includes claims and presentations that misrepresent the efficacy of Ozempic.","broader_use":"is misleading because it implies that all patients with type 2 diabetes are candidates for all the FDA-approved indications for Ozempic, when this is not the case","superiority":"The totality of these claims and presentations create a misleading impression by framing Ozempic as superior to other glucagon-like peptide 1 receptor agonists (GLP-1s) for type 2 diabetes.","risk_presentation":"The overall effect of disclosing risk information in this manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Ozempic."},"summary":"A direct-to-consumer online video for Ozempic. FDA said it misrepresented efficacy by implying all type 2 diabetes patients qualify for every indication, implied superiority over other GLP-1s without evidence, and undermined risk information by signaling the ad had ended before risks appeared.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191387/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1684,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"novo-nordisk-ozempic-2026-02-26"},{"id":"u191036","type":"untitled","date":"2026-02-06","company":"Sobi","listedAs":"Sobi, Inc.","brand":"VONJO","generic":"pacritinib","product":"VONJO® (pacritinib) capsules, for oral use","appType":"NDA","appNumber":"208712","matter":"723","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad (PP-28125) with a pop-up book theme","categories":["risk_omission","risk_presentation","efficacy_claims","broader_use"],"quotes":{"efficacy_claims":"However, the TSS endpoint failed when compared to the best available therapy (p=0.08).","broader_use":"The TV ad is misleading because it suggests the use of Vonjo in adults with certain types of MF and “low” platelet counts, without specifying what is considered “low.”","risk_omission":"By omitting this important risk information, the TV ad fails to provide material information about the consequences that may result from the use of Vonjo and creates a misleading impression about the drug’s safety.","risk_presentation":"these attention-grabbing visuals, frequent scene changes, and background music during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Vonjo implied quality-of-life benefits that the trial evidence did not support. It described the approved platelet-count population only vaguely, left out serious risks, and used distracting visuals and music during the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191036/download?attachment","promo":[],"closeoutDate":"2026-03-05","closeoutUrl":"https://www.fda.gov/media/191479/download?attachment","closeoutKnown":true,"closeoutDays":27,"words":1173,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"sobi-vonjo-2026-02-06"},{"id":"u191066","type":"untitled","date":"2026-02-06","company":"Johnson & Johnson","listedAs":"Janssen Biotech, Inc.","brand":"TREMFYA","generic":"guselkumab","product":"TREMFYA® (guselkumab) injection, for subcutaneous or intravenous use","appType":"BLA","appNumber":"761061","matter":"1242","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad 'TREMFYA DTC UC TVC SubQ Endcard'","categories":["risk_omission","efficacy_claims"],"quotes":{"efficacy_claims":"These claims misleadingly overstate the efficacy of Tremfya by suggesting that Tremfya has been shown to have a curative effect in patients with moderately to severely active ulcerative colitis","risk_omission":"The TV ad is also misleading because it includes claims and presentations about the uses and benefits of Tremfya but omits material risk information"},"summary":"A direct-to-consumer TV ad for Tremfya in ulcerative colitis overstated remission, endoscopic remission and healing results from selected patient subsets. It also left the infection risk warning out of the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191066/download?attachment","promo":[],"closeoutDate":"2026-06-17","closeoutUrl":"https://www.fda.gov/media/193428/download?attachment","closeoutKnown":true,"closeoutDays":131,"words":1425,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"johnson-johnson-tremfya-2026-02-06"},{"id":"u191020","type":"untitled","date":"2026-02-05","company":"Novo Nordisk","listedAs":"Novo Nordisk Inc.","brand":"Wegovy","generic":"","product":"WEGOVY® (semaglutide) tablets, for oral use","appType":"NDA","appNumber":"218316","matter":"6","audience":"consumer","channels":["tv_ad"],"piece":"TV ad for Wegovy pill","categories":["risk_presentation","efficacy_claims","superiority"],"quotes":{"superiority":"misleadingly suggest that because of its dosage form (i.e., pill), Wegovy offers an advancement or improvement (i.e., superior efficacy and/or safety) over other currently approved glucagon-like peptide-1 (GLP-1) treatments for weight loss.","efficacy_claims":"misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives","risk_presentation":"the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A TV ad for Wegovy in pill form implied it beats other approved GLP-1 weight-loss treatments and brings emotional and life benefits without supporting data. Its major statement also did not match the on-screen text to the audio.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/191020/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":691,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"novo-nordisk-wegovy-2026-02-05"},{"id":"u191010","type":"untitled","date":"2026-01-30","company":"argenx","listedAs":"argenx US, Inc.","brand":"VYVGART HYTRULO","generic":"efgartigimod alfa and hyaluronidase-qvfc","product":"VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use","appType":"BLA","appNumber":"761304","matter":"548","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad (US-VYV_HYT-24-00109)","categories":["risk_omission","risk_presentation","efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"This claim is misleading because the time to clinical deterioration, the primary endpoint of the clinical trial, is not the same as the risk of worsening.","dosing_convenience":"These claims and presentations are misleading because they suggest that the administration of Vyvgart Hytrulo can be completed in 30 seconds while participating in outdoor activities such as golfing, thereby oversimplifying the administration process.","risk_omission":"omits material risk information pertaining to the warning and precautions for hypersensitivity reactions and infusion/injection-related reactions","risk_presentation":"during the presentation of the major statement interfere with comprehension of the major statement"},"summary":"A direct-to-consumer TV ad for the CIDP treatment overstated how well patients can function on the drug and misrepresented trial results. FDA also said it oversimplified administration, left out allergic and injection-related reaction risks, and used distracting visuals during the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191010/download?attachment","promo":[],"closeoutDate":"2026-06-05","closeoutUrl":"https://www.fda.gov/media/193084/download?attachment","closeoutKnown":true,"closeoutDays":126,"words":1664,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"argenx-vyvgart-hytrulo-2026-01-30-2"},{"id":"u191009","type":"untitled","date":"2026-01-30","company":"argenx","listedAs":"argenx US, Inc.","brand":"VYVGART HYTRULO","generic":"efgartigimod alfa and hyaluronidase-qvfc","product":"VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use","appType":"BLA","appNumber":"761304","matter":"424","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad (US-VYV_HYT-25-00032)","categories":["risk_omission","risk_presentation","dosing_convenience"],"quotes":{"dosing_convenience":"These claims and presentations are misleading because they suggest that the administration of Vyvgart Hytrulo can be easily completed while traveling or attending an outdoor sporting event, thereby oversimplifying the administration process.","risk_omission":"omits material risk information pertaining to the warning and precautions for hypersensitivity reactions and infusion/injection-related reactions.","risk_presentation":"during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Vyvgart Hytrulo suggested that self-injection is easy while traveling or at sporting events. FDA said the ad oversimplified administration, left hypersensitivity and injection-related reaction risks out of the major statement, and used distracting visuals during the risk presentation.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/191009/download?attachment","promo":[],"closeoutDate":"2026-03-30","closeoutUrl":"https://www.fda.gov/media/193085/download?attachment","closeoutKnown":true,"closeoutDays":59,"words":1063,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"argenx-vyvgart-hytrulo-2026-01-30"},{"id":"u190753","type":"untitled","date":"2026-01-23","company":"ARS Pharmaceuticals","listedAs":"ARS Pharmaceutical Operations, Inc.","brand":"NEFFY","generic":"epinephrine nasal spray","product":"NEFFY® (epinephrine nasal spray)","appType":"NDA","appNumber":"214697","matter":"250","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (NEF-US-0882-1)","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"FDA is unaware of any evidence to support suggestions that treatment with Neffy has an effect on needle fear or otherwise has a positive impact on a patient’s mental or emotional state regarding needles.","dosing_convenience":"In addition, the TV ad is misleading regarding the storage and handling of Neffy."},"summary":"A direct-to-consumer TV ad for Neffy. FDA said its goodbye claims misleadingly suggested patients could avoid all injectable treatment, needle fear, stress and allergen precautions, and that it showed the device stored outside its blister pack, contrary to labeling.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/190753/download?attachment","promo":[],"closeoutDate":"2026-06-16","closeoutUrl":"https://www.fda.gov/media/193229/download?attachment","closeoutKnown":true,"closeoutDays":144,"words":1129,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ars-pharmaceuticals-neffy-2026-01-23"},{"id":"u190567","type":"untitled","date":"2026-01-07","company":"ImmunityBio","listedAs":"Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)","brand":"ANKTIVA","generic":"nogapendekin alfa inbakicept-pmln","product":"ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use","appType":"BLA","appNumber":"761336","matter":"51","audience":"both","channels":["website"],"piece":"HCP 'Efficacy and Safety' webpage and consumer 'Why ANKTIVA' webpage","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"misleadingly suggesting that QUILT-3.032 provided interpretable results regarding the effects of Anktiva on cystectomy avoidance and DSS, even though the design of the QUILT-3.032 study was not capable of establishing improvement on these time-to-event efficacy"},"summary":"An HCP efficacy webpage and a consumer webpage for Anktiva presented 36-month cystectomy avoidance and disease-specific survival results from a single-arm study. FDA said the study design could not produce interpretable results on these endpoints, so the claims were misleading.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/190567/download?attachment","promo":[{"url":"https://www.fda.gov/media/190568/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-27","closeoutUrl":"https://www.fda.gov/media/190820/download?attachment","closeoutKnown":true,"closeoutDays":20,"words":1122,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"immunitybio-anktiva-2026-01-07"},{"id":"u190549","type":"untitled","date":"2026-01-07","company":"BeOne Medicines","listedAs":"BeOne Medicines USA, Inc.","brand":"BRUKINSA","generic":"zanubrutinib","product":"BRUKINSA® (zanubrutinib) capsules and tablets, for oral use","appType":"NDA","appNumber":"218785","matter":"31","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad (0525-BRU-PRC-137) for Brukinsa","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"these claims and presentations create a misleading impression that patients on Brukinsa can maintain a normal, active lifestyle, thereby downplaying the serious side effects and monitoring requirements.","risk_presentation":"the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer TV ad for Brukinsa for CLL implied patients can keep a normal, active lifestyle, which downplays serious side effects and monitoring requirements. FDA also said the major statement lacked dual modality and was undercut by distracting visuals.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/190549/download?attachment","promo":[],"closeoutDate":"2026-03-05","closeoutUrl":"https://www.fda.gov/media/191478/download?attachment","closeoutKnown":true,"closeoutDays":57,"words":1000,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"beone-medicines-brukinsa-2026-01-07"},{"id":"u190458","type":"untitled","date":"2025-12-19","company":"Esperion Therapeutics","listedAs":"Esperion Therapeutics, Inc.","brand":"NEXLIZET","generic":"bempedoic acid and ezetimibe","product":"NEXLIZET® (bempedoic acid and ezetimibe) tablets, for oral use","appType":"NDA","appNumber":"211617","matter":"598","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer connected TV (CTV) broadcast advertisement","categories":["risk_presentation","superiority"],"quotes":{"superiority":"These claims and presentations misleadingly suggest that bempedoic acid, a component of\nNexlizet, is the only nonstatin \"FDA approved to lower bad cholesterol and reduce the risk of\nheart attack in statin intolerant patients\"","risk_presentation":"during the presentation of the major statement, which interfere with the\ncomprehension of the major statement."},"summary":"A direct-to-consumer connected TV ad for Nexlizet. FDA said it falsely suggested bempedoic acid is the only nonstatin approved and proven to reduce heart attack risk, and that distracting visuals interfered with comprehension of the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/190458/download?attachment","promo":[{"url":"https://www.fda.gov/media/190464/download?attachment","format":"PDF"}],"closeoutDate":"2026-02-10","closeoutUrl":"https://www.fda.gov/media/191090/download?attachment","closeoutKnown":true,"closeoutDays":53,"words":837,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"esperion-therapeutics-nexlizet-2025-12-19"},{"id":"u190245","type":"untitled","date":"2025-12-15","company":"Bristol Myers Squibb","listedAs":"Karuna Therapeutics, Inc., a Bristol Myers Squibb Co.","brand":"COBENFY","generic":"xanomeline and trospium chloride","product":"COBENFY™ (xanomeline and trospium chloride) capsules, for oral use","appType":"NDA","appNumber":"216158","matter":"175","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer broadcast TV ad (1629-US-2500690) featuring Bryan","categories":["risk_presentation","efficacy_claims","broader_use"],"quotes":{"efficacy_claims":"These claims and presentations create a misleading representation that treatment with Cobenfy will improve both the positive and negative symptoms of schizophrenia.","broader_use":"This claim misleadingly suggests that Cobenfy has efficacy in treatment-refractory cases of schizophrenia, when this has not been demonstrated.","risk_presentation":"during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Cobenfy suggested it improves negative symptoms, implied it works in treatment-refractory schizophrenia, and said it is not an antipsychotic. Its distracting visuals also interfered with comprehension of the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/190245/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1153,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bristol-myers-squibb-cobenfy-2025-12-15"},{"id":"u190494","type":"untitled","date":"2025-12-15","company":"BeOne Medicines","listedAs":"BeOne Medicines USA, Inc.","brand":"TEVIMBRA","generic":"tislelizumab-jsgr","product":"TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use","appType":"BLA","appNumber":"761232","matter":"47","audience":"professional","channels":["other"],"piece":"Two branded Teams backgrounds 'TEVIMBRA Pan Tumor Teams Backgrounds'","categories":["risk_omission","missing_disclosure"],"quotes":{"risk_omission":"However, the branded backgrounds fail to communicate any risk information about the product.","missing_disclosure":"By failing to adequately communicate the indication for Tevimbra, the branded backgrounds create a misleading impression about the drug’s FDA-approved indication."},"summary":"Two branded Microsoft Teams backgrounds promoting Tevimbra for upper GI cancers gave no risk information and did not adequately state the drug's specific FDA-approved indications.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/190494/download?attachment","promo":[{"url":"https://www.fda.gov/media/190495/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-21","closeoutUrl":"https://www.fda.gov/media/190822/download?attachment","closeoutKnown":true,"closeoutDays":37,"words":868,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"beone-medicines-tevimbra-2025-12-15"},{"id":"u189913","type":"untitled","date":"2025-11-24","company":"Daiichi Sankyo","listedAs":"Daiichi Sankyo, Inc.","brand":"TURALIO","generic":"pexidartinib","product":"TURALIO® (pexidartinib) capsules, for oral use","appType":"NDA","appNumber":"211810","matter":"253","audience":"consumer","channels":["online_video"],"piece":"DTC 'Patient Ambassador Video_2025 BW Label Update' patient testimonial video","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"misleadingly suggests that treatment with Turalio will allow all patients to live as they did prior to their TGCT diagnosis, when this has not been demonstrated."},"summary":"A direct-to-consumer patient testimonial video for Turalio. FDA objected that its before-and-after presentation suggested all patients would have complete resolution of TGCT, regain daily function and gain better quality of life, which the study data do not support.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/189913/download?attachment","promo":[],"closeoutDate":"2026-01-27","closeoutUrl":"https://www.fda.gov/media/190823/download?attachment","closeoutKnown":true,"closeoutDays":64,"words":1688,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"daiichi-sankyo-turalio-2025-11-24"},{"id":"u189733","type":"untitled","date":"2025-09-30","company":"SK Life Science","listedAs":"SK Life Science, Inc.","brand":"Xcopri","generic":"cenobamate","product":"Xcopri® (cenobamate tablets) for oral use, CV","appType":"NDA","appNumber":"212839","matter":"592","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'Road to Reduction XCOPRI DTC Commercial'","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"but completely omits the warning and precaution regarding liver injury from the WARNINGS AND PRECAUTIONS, Liver Injury section of the FDA-approved Prescribing Information.","risk_presentation":"Therefore, the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer TV ad for Xcopri left out the liver injury warning and QT shortening risk information. FDA also said its major statement omitted material risk information from the audio and did not present risks in both audio and text.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/189733/download?attachment","promo":[],"closeoutDate":"2025-11-28","closeoutUrl":"https://www.fda.gov/media/191764/download?attachment","closeoutKnown":true,"closeoutDays":59,"words":877,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"sk-life-science-xcopri-2025-09-30"},{"id":"u189734","type":"untitled","date":"2025-09-30","company":"PharmaTher","listedAs":"PharmaTher Inc.","brand":"Ketamine","generic":"ketamine","product":"ANDA 217858 KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CII MA 2","appType":"ANDA","appNumber":"217858","matter":"2","audience":"professional","channels":["website"],"piece":"Ketamine product webpage","categories":["broader_use","form_2253"],"quotes":{"broader_use":"The webpage suggests the use of Ketamine in all surgical and diagnostic procedures, but it does not specify its use in procedures that do not require skeletal muscle relaxation","form_2253":"A copy of the webpage was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required."},"summary":"A webpage for PharmaTher's generic ketamine injection described its approval as for surgical pain management and suggested use in all surgical and diagnostic procedures, misrepresenting the approved indication. The webpage was also not submitted to FDA on Form FDA-2253 at first publication.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/189734/download?attachment","promo":[{"url":"https://www.fda.gov/media/189735/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-09","closeoutUrl":"https://www.fda.gov/media/190309/download?attachment","closeoutKnown":true,"closeoutDays":70,"words":665,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"pharmather-ketamine-2025-09-30"},{"id":"u188954","type":"untitled","date":"2025-09-23","company":"Novartis","listedAs":"Novartis Pharmaceuticals Corporation","brand":"FABHALTA","generic":"iptacopan","product":"FABHALTA® ( iptacopan) capsules, for oral use","appType":"NDA","appNumber":"218276","matter":"637","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (FA-11370984)","categories":["risk_presentation","efficacy_claims"],"quotes":{"risk_presentation":"combined with multiple scene changes and background music during the presentation of the major statement, interferes with comprehension of the major statement.","efficacy_claims":"distract the viewer from material information about the benefits of Fabhalta and, therefore, creates a misleading impression about the drug’s efficacy."},"summary":"A direct-to-consumer TV ad for Fabhalta. FDA said attention-grabbing visuals, scene changes and music distracted from the major risk statement, and that fast, competing presentations undermined the study data qualifying the hemoglobin improvement claim.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188954/download?attachment","promo":[{"url":"https://www.fda.gov/media/188955/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-03","closeoutUrl":"https://www.fda.gov/media/190080/download?attachment","closeoutKnown":true,"closeoutDays":71,"words":1116,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"novartis-fabhalta-2025-09-23"},{"id":"u189634","type":"untitled","date":"2025-09-23","company":"AstraZeneca","listedAs":"AstraZeneca","brand":"FARXIGA","generic":"dapagliflozin","product":"FARXIGA® (dapagliflozin) tablets, for oral use","appType":"NDA","appNumber":"202293","matter":"2327","audience":"consumer","channels":["tv_ad"],"piece":"45-second TV ad 'FARXIGA DTC TV: 45 – Places You Want to Be v2'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The TV ad is misleading because it misleadingly represents that Farxiga was approved only on the single endpoint of “reducing the risk of cardiovascular death” in adults with chronic kidney disease"},"summary":"A direct-to-consumer TV ad for Farxiga suggested the drug was approved only to reduce the risk of cardiovascular death in adults with chronic kidney disease or heart failure. FDA said this left out the other parts of the approved indications.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/189634/download?attachment","promo":[],"closeoutDate":"2025-11-25","closeoutUrl":"https://www.fda.gov/media/189991/download?attachment","closeoutKnown":true,"closeoutDays":63,"words":905,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-farxiga-2025-09-23"},{"id":"u188906","type":"untitled","date":"2025-09-09","company":"UCB","listedAs":"UCB, Inc.","brand":"RYSTIGGO","generic":"rozanolixizumab-noli","product":"RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use","appType":"BLA","appNumber":"761286","matter":"286","audience":"professional","channels":["website"],"piece":"Healthcare provider website landing, Efficacy and Study Design webpages","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"misleadingly suggest that Rystiggo provides a greater magnitude of benefit in the treatment of gMG than has been demonstrated","dosing_convenience":"Therefore, these results do not correlate with the “rapid” and near-complete resolution of gMG symptoms portrayed by the claims and presentations."},"summary":"The landing, Efficacy and Study Design pages of a healthcare provider website showed rapid-efficacy claims and animations of people moving without impairment. FDA said these overstated the benefit and how fast it appears, compared with the clinical trial results.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188906/download?attachment","promo":[{"url":"https://www.fda.gov/media/188896/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":865,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ucb-rystiggo-2025-09-09"},{"id":"u188695","type":"untitled","date":"2025-09-09","company":"UCB","listedAs":"UCB, Inc.","brand":"BIMZELX","generic":"bimekizumab-bkzx","product":"BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use","appType":"BLA","appNumber":"761151","matter":"279","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'Can't Wait To Say I'm Back 60'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"the magnitude of change suggested by these claims implies a greater improvement than was demonstrated in the clinical trials for Bimzelx."},"summary":"A direct-to-consumer TV ad for Bimzelx used patient narrative claims of transformative relief. FDA said these claims overstated the benefit shown in the clinical trials and created a misleading impression of treatment results.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188695/download?attachment","promo":[{"url":"https://www.fda.gov/media/188696/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-06","closeoutUrl":"https://www.fda.gov/media/190548/download?attachment","closeoutKnown":true,"closeoutDays":119,"words":605,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ucb-bimzelx-2025-09-09-3"},{"id":"u188693","type":"untitled","date":"2025-09-09","company":"UCB","listedAs":"UCB, Inc.","brand":"BIMZELX","generic":"bimekizumab-bkzx","product":"BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use","appType":"BLA","appNumber":"761151","matter":"310","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad 'Fade Cut'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The totality of these claims and representations misleadingly suggests that Bimzelx has a positive impact on one’s health-related quality of life (HRQoL).","risk_presentation":"some with frequent scene changes, during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Bimzelx suggested the drug improves emotional and social functioning in plaque psoriasis, which was not evaluated in its trials. Attention-grabbing visuals during the major statement also interfered with comprehension of the risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188693/download?attachment","promo":[{"url":"https://www.fda.gov/media/188694/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-06","closeoutUrl":"https://www.fda.gov/media/190546/download?attachment","closeoutKnown":true,"closeoutDays":119,"words":1069,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ucb-bimzelx-2025-09-09-2"},{"id":"u188691","type":"untitled","date":"2025-09-09","company":"UCB","listedAs":"UCB, Inc.","brand":"BIMZELX","generic":"bimekizumab-bkzx","product":"BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use","appType":"BLA","appNumber":"761151","matter":"337","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad 'Chaquira'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The totality of these claims and representations misleadingly suggests that Bimzelx has a positive impact on one’s health-related quality of life (HRQoL).","risk_presentation":"attention-grabbing visuals (e.g., patient amidst an industrious office scene and a busy restaurant engagement), some with frequent scene changes, during the presentation of the major statement interfere with comprehension of the major statement"},"summary":"A direct-to-consumer TV ad for Bimzelx in hidradenitis suppurativa suggested transformative improvements in emotional and social functioning without supporting data. FDA also said distracting visuals during the major statement interfered with comprehension of the risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188691/download?attachment","promo":[{"url":"https://www.fda.gov/media/188692/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-06","closeoutUrl":"https://www.fda.gov/media/190547/download?attachment","closeoutKnown":true,"closeoutDays":119,"words":1046,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ucb-bimzelx-2025-09-09"},{"id":"u188720","type":"untitled","date":"2025-09-09","company":"Teva Neuroscience","listedAs":"Teva Neuroscience, Inc.","brand":"AUSTEDO XR","generic":"deutetrabenazine","product":"AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use","appType":"NDA","appNumber":"216354","matter":"380","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'As You Go Spot #2'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These presentations misleadingly suggest that Austedo XR provides a greater magnitude of benefit in the treatment of TD than has been demonstrated."},"summary":"A direct-to-consumer TV ad for Austedo XR showed a patient with tardive dyskinesia moving with near-complete steadiness after treatment. FDA said this overstated the benefit shown in clinical studies, and that the on-screen disclaimers did not correct the impression.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/188720/download?attachment","promo":[],"closeoutDate":"2026-01-21","closeoutUrl":"https://www.fda.gov/media/191761/download?attachment","closeoutKnown":true,"closeoutDays":134,"words":978,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"teva-neuroscience-austedo-xr-2025-09-09-2"},{"id":"u188719","type":"untitled","date":"2025-09-09","company":"Teva Neuroscience","listedAs":"Teva Neuroscience, Inc.","brand":"AUSTEDO XR","generic":"deutetrabenazine","product":"AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use","appType":"NDA","appNumber":"216354","matter":"342","audience":"consumer","channels":["tv_ad"],"piece":"TV ads 'Daughter Knows Best' and 'Spouse Knows Best'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These presentations misleadingly suggest that Austedo XR provides a greater magnitude of benefit in the treatment of TD than has been demonstrated."},"summary":"Two direct-to-consumer TV ads for Austedo XR showed patients with tardive dyskinesia having near-complete resolution of involuntary movements after treatment. FDA said this overstated the modest benefit shown in the clinical studies.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188719/download?attachment","promo":[],"closeoutDate":"2026-02-26","closeoutUrl":"https://www.fda.gov/media/191760/download?attachment","closeoutKnown":true,"closeoutDays":170,"words":1014,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"teva-neuroscience-austedo-xr-2025-09-09"},{"id":"u188900","type":"untitled","date":"2025-09-09","company":"Takeda","listedAs":"Takeda Pharmaceuticals America, Inc.","brand":"ICLUSIG","generic":"ponatinib","product":"ICLUSIG® (ponatinib) tablets, for oral use","appType":"NDA","appNumber":"203469","matter":"695","audience":"professional","channels":["website"],"piece":"HCP website webpages 'T315I Mutation', 'OPTIC Efficacy', 'PACE Efficacy'","categories":["efficacy_claims","superiority"],"quotes":{"efficacy_claims":"misleadingly suggesting that PACE and OPTIC trials provided interpretable results regarding the effects of Iclusig on PFS and OS endpoints","superiority":"These claims misleadingly represent that the current NCCN Guidelines® state that Iclusig is the preferred treatment option for the treatment of CML in patients with a T315I mutation in any phase"},"summary":"Healthcare provider webpages for Iclusig presented overall and progression-free survival results from single-arm trials as interpretable. They also claimed the NCCN guidelines name ponatinib the preferred option for T315I-mutated CML in any phase. The current guidelines do not say that.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188900/download?attachment","promo":[{"url":"https://www.fda.gov/media/188909/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-03","closeoutUrl":"https://www.fda.gov/media/190034/download?attachment","closeoutKnown":true,"closeoutDays":85,"words":1457,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"takeda-iclusig-2025-09-09"},{"id":"u188752","type":"untitled","date":"2025-09-09","company":"Takeda","listedAs":"Takeda Pharmaceuticals USA, Inc.","brand":"FRUZAQLA","generic":"fruquintinib","product":"FRUZAQLA® (fruquintinib) capsules, for oral use","appType":"NDA","appNumber":"217564","matter":"174","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (US-FRZ-0501v1.0)","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"The TV ad is misleading because it presents efficacy claims and representations for Fruzaqla\nbut fails to communicate the warning and precaution of gastrointestinal perforation.","risk_presentation":"during\nthe presentation of the major statement interferes with comprehension of the major\nstatement."},"summary":"A direct-to-consumer TV ad for Fruzaqla made efficacy claims but did not mention the risk of gastrointestinal perforation. FDA also said distracting visuals during the major statement interfered with viewers understanding it.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188752/download?attachment","promo":[{"url":"https://www.fda.gov/media/188753/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-24","closeoutUrl":"https://www.fda.gov/media/189905/download?attachment","closeoutKnown":true,"closeoutDays":76,"words":608,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"takeda-fruzaqla-2025-09-09-2"},{"id":"u188744","type":"untitled","date":"2025-09-09","company":"Takeda","listedAs":"Takeda Pharmaceuticals USA, Inc.","brand":"FRUZAQLA","generic":"fruquintinib","product":"FRUZAQLA® (fruquintinib) capsules, for oral use","appType":"NDA","appNumber":"217564","matter":"174","audience":"consumer","channels":["website"],"piece":"'Quality of Life' webpage on the FRUZAQLA consumer website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These representations create a misleading impression that Fruzaqla has demonstrated a benefit on the patient reported outcome (PRO) measure of global quality of life (QoL), 3,4 when this is not the case."},"summary":"A Quality of Life webpage on the Fruzaqla consumer website presented FRESCO-2 patient-reported outcome data. FDA said the data were exploratory and too limited to support it, so the page misleadingly suggested a quality of life benefit.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188744/download?attachment","promo":[{"url":"https://www.fda.gov/media/188741/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-05","closeoutUrl":"https://www.fda.gov/media/190468/download?attachment","closeoutKnown":true,"closeoutDays":118,"words":1547,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"takeda-fruzaqla-2025-09-09"},{"id":"u188727","type":"untitled","date":"2025-09-09","company":"Supernus Pharmaceuticals","listedAs":"Supernus Pharmaceuticals, Inc.","brand":"Qelbree","generic":"viloxazine extended-release capsules","product":"QELBREE® (viloxazine extended-release capsules), for oral use","appType":"NDA","appNumber":"211964","matter":"497","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad 'Flying Colors'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"These presentations misleadingly suggest that Qelbree provides a greater magnitude of benefit in the treatment of ADHD than has been demonstrated.","risk_presentation":"The TV ad is misleading because frequent scene changes during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Qelbree showed adults with ADHD symptoms resolving completely, overstating the benefit shown in clinical studies. FDA also said frequent scene changes interfered with the major statement and upbeat visuals minimized the risks.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188727/download?attachment","promo":[{"url":"https://www.fda.gov/media/188728/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":857,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"supernus-pharmaceuticals-qelbree-2025-09-09-2"},{"id":"u188725","type":"untitled","date":"2025-09-09","company":"Supernus Pharmaceuticals","listedAs":"Supernus Pharmaceuticals, Inc.","brand":"Qelbree","generic":"viloxazine extended-release capsules","product":"QELBREE® (viloxazine extended-release capsules), for oral use","appType":"NDA","appNumber":"211964","matter":"497","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad 'Turn the Tables'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"These presentations misleadingly suggest that Qelbree provides a greater magnitude of benefit in the treatment of ADHD than has been demonstrated.","risk_presentation":"The TV ad is misleading because frequent scene changes during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Qelbree showed children whose ADHD symptoms resolved completely, which overstated the benefit shown in trials. FDA also said frequent scene changes during the major statement and happy visuals during risk information minimized the risks.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188725/download?attachment","promo":[{"url":"https://www.fda.gov/media/188726/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":882,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"supernus-pharmaceuticals-qelbree-2025-09-09"},{"id":"u188713","type":"untitled","date":"2025-09-09","company":"Sanofi","listedAs":"Sanofi","brand":"TZIELD","generic":"teplizumab-mzwv","product":"TZIELD® (teplizumab-mzwv) injection, for intravenous use","appType":"BLA","appNumber":"761183","matter":"377","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'Tzield WHEN Anthem OLV/CTV: 60s Spot-Family History'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The TV ad includes claims and presentations that misrepresent the efficacy of Tzield.","risk_presentation":"the TV ad is misleading because of the frequent scene changes and compelling, attention-grabbing visuals (e.g., the dog skating on a skateboard) during the presentation of the major statement"},"summary":"A direct-to-consumer TV ad for Tzield suggested the drug improves quality of life and lets patients overcome type 1 diabetes, which data do not support. Frequent scene changes and distracting visuals also interfered with the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188713/download?attachment","promo":[],"closeoutDate":"2025-11-25","closeoutUrl":"https://www.fda.gov/media/189990/download?attachment","closeoutKnown":true,"closeoutDays":77,"words":963,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"sanofi-tzield-2025-09-09"},{"id":"u188905","type":"untitled","date":"2025-09-09","company":"Pinnacle Biologics","listedAs":"Pinnacle Biologics, Inc.","brand":"PHOTOFRIN","generic":"porfimer sodium","product":"PHOTOFRIN® (porfimer sodium) for injection, for intravenous use","appType":"NDA","appNumber":"020451","matter":"178","audience":"professional","channels":["exhibit"],"piece":"Exhibit booth panel 'Tradeshow Booth Backdrop_Esophageal'","categories":["risk_omission"],"quotes":{"risk_omission":"The exhibit panel is misleading because it presents efficacy claims and representations for Photofrin but fails to communicate any risk information."},"summary":"An exhibit booth panel for Photofrin presented efficacy claims and esophageal cancer treatment images but left out all risk information, which FDA said created a misleading impression of the drug's safety.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188905/download?attachment","promo":[{"url":"https://www.fda.gov/media/188912/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-13","closeoutUrl":"https://www.fda.gov/media/189666/download?attachment","closeoutKnown":true,"closeoutDays":65,"words":728,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"pinnacle-biologics-photofrin-2025-09-09-2"},{"id":"u188904","type":"untitled","date":"2025-09-09","company":"Pinnacle Biologics","listedAs":"Pinnacle Biologics, Inc.","brand":"PHOTOFRIN","generic":"porfimer sodium","product":"PHOTOFRIN® (porfimer sodium) for injection, for intravenous use","appType":"NDA","appNumber":"020451","matter":"178","audience":"professional","channels":["exhibit"],"piece":"Exhibit booth panel 'Tradeshow Booth Backdrop - NSCLC'","categories":["risk_omission"],"quotes":{"risk_omission":"The exhibit panel is misleading because it presents efficacy claims and representations for Photofrin but fails to communicate any risk information."},"summary":"A tradeshow exhibit booth panel for Photofrin presented efficacy claims and treatment images for endobronchial cancer. FDA objected that it omitted all risk information, which created a misleading impression of the drug's safety.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188904/download?attachment","promo":[{"url":"https://www.fda.gov/media/188895/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-13","closeoutUrl":"https://www.fda.gov/media/189665/download?attachment","closeoutKnown":true,"closeoutDays":65,"words":718,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"pinnacle-biologics-photofrin-2025-09-09"},{"id":"u188756","type":"untitled","date":"2025-09-09","company":"Phathom Pharmaceuticals","listedAs":"Phathom Pharmaceuticals, Inc.","brand":"VOQUEZNA","generic":"vonoprazan","product":"VOQUEZNA (vonoprazan) tablets, for oral use","appType":"NDA","appNumber":"215151","matter":"185","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Direct-to-consumer video interview featuring spokesperson Kenan Thompson","categories":["risk_omission"],"quotes":{"risk_omission":"The video, however, entirely omits all risk information. By omitting the risks associated with\nVoquezna, the video fails to provide material information about the consequences that may"},"summary":"A direct-to-consumer video interview with paid spokesperson Kenan Thompson, posted on Rolling Out and its YouTube page, made efficacy claims for Voquezna. FDA objected that the video left out all risk information and gave a misleading impression of the drug's safety.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/188756/download?attachment","promo":[],"closeoutDate":"2025-11-24","closeoutUrl":"https://www.fda.gov/media/190312/download?attachment","closeoutKnown":true,"closeoutDays":76,"words":712,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"phathom-pharmaceuticals-voquezna-2025-09-09-3"},{"id":"u188755","type":"untitled","date":"2025-09-09","company":"Phathom Pharmaceuticals","listedAs":"Phathom Pharmaceuticals, Inc.","brand":"VOQUEZNA","generic":"vonoprazan","product":"VOQUEZNA (vonoprazan) tablets, for oral use","appType":"NDA","appNumber":"215151","matter":"185","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Direct-to-consumer video interview featuring spokesperson Kenan Thompson","categories":["risk_omission"],"quotes":{"risk_omission":"The video, however, entirely omits all risk information. By omitting the risks associated with Voquezna, the video fails to provide material information about the consequences that may result from the use of Voquezna"},"summary":"A direct-to-consumer video interview with paid spokesperson Kenan Thompson promoted Voquezna. FDA said the video made efficacy claims but left out all risk information, which created a misleading impression of the drug's safety.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/188755/download?attachment","promo":[],"closeoutDate":"2025-11-24","closeoutUrl":"https://www.fda.gov/media/190312/download?attachment","closeoutKnown":true,"closeoutDays":76,"words":666,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"phathom-pharmaceuticals-voquezna-2025-09-09-2"},{"id":"u188754","type":"untitled","date":"2025-09-09","company":"Phathom Pharmaceuticals","listedAs":"Phathom Pharmaceuticals, Inc.","brand":"VOQUEZNA","generic":"vonoprazan","product":"VOQUEZNA (vonoprazan) tablets, for oral use","appType":"NDA","appNumber":"215151","matter":"185","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Kenan Thompson interview video on The Dan Le Batard Show","categories":["risk_omission"],"quotes":{"risk_omission":"By omitting the risks associated with\nVoquezna, the video fails to provide material information about the consequences that may\nresult from the use of Voquezna and creates a misleading impression about the drug’s\nsafety."},"summary":"A direct-to-consumer video interview with paid spokesperson Kenan Thompson, aired on a podcast show and posted on YouTube, presented efficacy claims for Voquezna. FDA objected that it left out all risk information.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/188754/download?attachment","promo":[],"closeoutDate":"2025-11-24","closeoutUrl":"https://www.fda.gov/media/190312/download?attachment","closeoutKnown":true,"closeoutDays":76,"words":637,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"phathom-pharmaceuticals-voquezna-2025-09-09"},{"id":"u188715","type":"untitled","date":"2025-09-09","company":"Pfizer","listedAs":"Pfizer, Inc.","brand":"VELSIPITY","generic":"etrasimod","product":"VELSIPITY™ (etrasimod) tablets, for oral use","appType":"NDA","appNumber":"216956","matter":"228","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (PP-V1A-USA-1028) featuring ulcerative colitis creature","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The images of a creature depicting ulcerative colitis (UC) throughout the TV ad misleadingly\noverstate the efficacy of Velsipity.","risk_presentation":"chewing on something it\nfound outside during the presentation of the major statement interfere with comprehension of\nthe major statement."},"summary":"A direct-to-consumer TV ad for Velsipity used images of a creature representing ulcerative colitis. FDA said the visuals overstated efficacy beyond the clinical remission rates shown in studies, and that distracting creature actions during the major statement interfered with comprehension of risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188715/download?attachment","promo":[{"url":"https://www.fda.gov/media/188716/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-01","closeoutUrl":"https://www.fda.gov/media/190311/download?attachment","closeoutKnown":true,"closeoutDays":83,"words":718,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"pfizer-velsipity-2025-09-09"},{"id":"wnovo-nordisk-inc-716495-09092025","type":"warning","date":"2025-09-09","company":"Novo Nordisk","listedAs":"","brand":"Wegovy","generic":"semaglutide","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["tv_ad","website","online_video","spokesperson"],"piece":"42-minute video 'An Oprah Special: Shame, Blame, and the Weight Loss Revolution'","categories":["risk_omission","form_2253"],"quotes":{"risk_omission":"The video includes numerous representations about the benefits of Wegovy, Ozempic, and Victoza made by representatives of Novo Nordisk, but omits important risk information and otherwise minimizes the risks of these drug products.","form_2253":"In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A direct-to-consumer Oprah television special featuring paid Novo Nordisk consultants and a company executive promoted Wegovy, Ozempic and Victoza. FDA said it omitted and minimized serious risks, including boxed warning information, and was not submitted at first dissemination.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-716495-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":2959,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"novo-nordisk-wegovy-2025-09-09"},{"id":"u188710","type":"untitled","date":"2025-09-09","company":"Novartis","listedAs":"Novartis Pharmaceuticals Corporation","brand":"PLUVICTO","generic":"lutetium lu 177 vipivotide tetraxetan","product":"PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use","appType":"NDA","appNumber":"215833","matter":"587","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer broadcast TV ad (FA-11446517)","categories":["risk_presentation","efficacy_claims","broader_use"],"quotes":{"efficacy_claims":"misleading by suggesting that despite trying and failing previous prostate cancer treatments, perseverance combined with taking Pluvicto will definitively result in a successful outcome in treating prostate cancer.","broader_use":"By failing to adequately communicate the indication for Pluvicto, the TV ad creates a misleading impression about the drug’s FDA-approved indication.","risk_presentation":"during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Pluvicto suggested that persistence plus treatment would surely succeed against prostate cancer, overstating response rates. It also left out part of the approved indication and used distracting visuals during the major risk statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188710/download?attachment","promo":[{"url":"https://www.fda.gov/media/188711/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-11","closeoutUrl":"https://www.fda.gov/media/190160/download?attachment","closeoutKnown":true,"closeoutDays":93,"words":872,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"novartis-pluvicto-2025-09-09"},{"id":"u188751","type":"untitled","date":"2025-09-09","company":"Novartis","listedAs":"Novartis Pharmaceuticals Corporation","brand":"KISQALI","generic":"ribociclib","product":"KISQALI® (ribociclib) tablets, for oral use","appType":"NDA","appNumber":"209092","matter":"1975","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'KISQALI_mBC_OKE_Jordan 60 Second Major Statement Update'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"This claim creates a misleading impression about the efficacy of the drug."},"summary":"A 60-second TV ad for Kisqali presented overall survival data for premenopausal women from an exploratory analysis that was not pre-specified. FDA found this misleading about efficacy. It also said the supporting on-screen text was too fast to read and competed with the audio.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188751/download?attachment","promo":[{"url":"https://www.fda.gov/media/188745/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1109,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"novartis-kisqali-2025-09-09"},{"id":"u188723","type":"untitled","date":"2025-09-09","company":"Novartis","listedAs":"Novartis Pharmaceuticals Corporation","brand":"Kesimpta","generic":"ofatumumab","product":"KESIMPTA® (ofatumumab) injection, for subcutaneous use","appType":"BLA","appNumber":"125326","matter":"1749","audience":"consumer","channels":["tv_ad"],"piece":"60-second DTC TV ad 'KSM DTC My Time My Way'","categories":["risk_presentation","dosing_convenience"],"quotes":{"dosing_convenience":"This claim and presentation are misleading because they suggest that the overall administration process of Kesimpta can be completed in “1 minute,” thereby oversimplifying the steps involved.","risk_presentation":"during the presentation of the major statement interferes with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Kesimpta claimed it takes one minute a month at home, which FDA said oversimplifies administration. FDA also said attention-grabbing visuals during the major statement interfered with comprehension of the risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188723/download?attachment","promo":[{"url":"https://www.fda.gov/media/188724/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-28","closeoutUrl":"https://www.fda.gov/media/191763/download?attachment","closeoutKnown":true,"closeoutDays":80,"words":738,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"novartis-kesimpta-2025-09-09"},{"id":"u188721","type":"untitled","date":"2025-09-09","company":"Neurocrine Biosciences","listedAs":"Neurocrine Biosciences, Inc","brand":"INGREZZA","generic":"valbenazine","product":"INGREZZA® (valbenazine) capsules, for oral use","appType":"NDA","appNumber":"209241","matter":"1086","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'TakING on TD Pool Out 1'","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"These presentations misleadingly suggest that Ingrezza provides a greater magnitude of benefit in the treatment of TD than has been demonstrated.","dosing_convenience":"These claims misleadingly suggest that patients will experience improvement in TD symptoms earlier than was demonstrated in the clinical trial."},"summary":"A direct-to-consumer TV ad for Ingrezza showed near-complete resolution of tardive dyskinesia movements. It also made early-onset claims based on an exploratory week 2 endpoint and satisfaction claims drawn from an enriched rollover population. FDA found these overstated benefit and onset.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188721/download?attachment","promo":[{"url":"https://www.fda.gov/media/188722/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-04","closeoutUrl":"https://www.fda.gov/media/191762/download?attachment","closeoutKnown":true,"closeoutDays":86,"words":1144,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"neurocrine-biosciences-ingrezza-2025-09-09"},{"id":"u188701","type":"untitled","date":"2025-09-09","company":"Nalpropion Pharmaceuticals","listedAs":"Nalpropion Pharmaceuticals, LLC","brand":"Contrave","generic":"naltrexone hydrochloride and bupropion hydrochloride","product":"CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended release tablets, for oral use","appType":"NDA","appNumber":"200063","matter":"944","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'CONTRAVE TV Spot 60 Sec_v2'","categories":["risk_omission","efficacy_claims"],"quotes":{"efficacy_claims":"The TV ad includes claims and presentations that misrepresent the efficacy of Contrave.","risk_omission":"By omitting these serious risks associated with Contrave and material information pertaining to the risks of Contrave, the TV ad creates a misleading impression of the drug’s safety."},"summary":"A 60-second direct-to-consumer TV ad for Contrave. FDA said it suggested the drug's mechanism of action is fully understood. FDA also said it left out the mania warning, the directive to stop taking the drug, and the seizure risk.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188701/download?attachment","promo":[{"url":"https://www.fda.gov/media/188702/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1275,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"nalpropion-pharmaceuticals-contrave-2025-09-09"},{"id":"u188907","type":"untitled","date":"2025-09-09","company":"Ipsen Biopharmaceuticals","listedAs":"Ipsen Biopharmaceuticals, Inc.","brand":"TAZVERIK","generic":"tazemetostat","product":"TAZVERIK® (tazemetostat) tablets, for oral use","appType":"NDA","appNumber":"211723","matter":"572","audience":"professional","channels":["website"],"piece":"'Clinical Trial Results' webpage on Tazverik follicular lymphoma HCP website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"this promotional communication makes misleading representations or suggestions about the efficacy of Tazverik by presenting DCR calculations that include SD based on Study E7438-G000-101, which, as a single-arm trial, is not capable of supporting such representations or suggestions."},"summary":"A Clinical Trial Results webpage on the Tazverik follicular lymphoma healthcare provider website showed tumor volume reductions as disease control rates that included stable disease. FDA said the single-arm trial behind these figures could not support them, so the efficacy presentation was misleading.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188907/download?attachment","promo":[{"url":"https://www.fda.gov/media/188899/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-17","closeoutUrl":"https://www.fda.gov/media/189800/download?attachment","closeoutKnown":true,"closeoutDays":69,"words":1351,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ipsen-biopharmaceuticals-tazverik-2025-09-09"},{"id":"u188903","type":"untitled","date":"2025-09-09","company":"Incyte","listedAs":"Incyte Corporation","brand":"PEMAZYRE","generic":"pemigatinib","product":"PEMAZYRE® (pemigatinib) tablets, for oral use","appType":"NDA","appNumber":"213736","matter":"459","audience":"professional","channels":["sales_aid"],"piece":"Professional sales aid 'CCA CVA Update Print 8.5x11'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These representations make this promotional communication misleading by suggesting that Pemazyre improves DCR in patients with locally advanced or metastatic CCA based on a composite of complete response (CR), partial response (PR), and stable disease (SD)"},"summary":"A professional sales aid for Pemazyre presented disease control rate, progression-free survival and overall survival results from the single-arm FIGHT-202 trial. FDA said that trial design cannot support these efficacy representations and that the disclosures of its limitations did not correct the misleading impression.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188903/download?attachment","promo":[{"url":"https://www.fda.gov/media/188911/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-20","closeoutUrl":"https://www.fda.gov/media/189828/download?attachment","closeoutKnown":true,"closeoutDays":72,"words":1650,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"incyte-pemazyre-2025-09-09"},{"id":"u188898","type":"untitled","date":"2025-09-09","company":"ImmunityBio","listedAs":"Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)","brand":"ANKTIVA","generic":"nogapendekin alfa inbakicept-pmln","product":"ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use","appType":"BLA","appNumber":"761336","matter":"35","audience":"professional","channels":["website"],"piece":"'Efficacy and Safety' webpage on ANKTIVA HCP branded website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"misleadingly suggesting that QUILT-3.032 provided interpretable results regarding the effects of Anktiva on cystectomy avoidance and DSS, even though the design of the QUILT-3.032 study was not capable of establishing improvement on these time-to-event efficacy endpoints"},"summary":"A healthcare provider webpage for Anktiva presented cystectomy avoidance and disease-specific survival results from a single-arm study. FDA said the study design could not establish these time-to-event endpoints, so the results were uninterpretable and the claims were misleading.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188898/download?attachment","promo":[{"url":"https://www.fda.gov/media/188893/download?attachment","format":"PDF"}],"closeoutDate":"2026-01-27","closeoutUrl":"https://www.fda.gov/media/190821/download?attachment","closeoutKnown":true,"closeoutDays":140,"words":808,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"immunitybio-anktiva-2025-09-09"},{"id":"u189906","type":"untitled","date":"2025-09-09","company":"GlaxoSmithKline","listedAs":"GlaxoSmithKline LLC","brand":"APRETUDE","generic":"cabotegravir extended-release injectable suspension","product":"NDA 215499 APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use","appType":"NDA","appNumber":"215499","matter":"706","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'A Game 60 TV Ad Pool Out 2025'","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"These claims and presentations misleadingly suggest that Apretude provides a sense of sexual freedom without the need to practice safer sex to reduce the risk of sexually transmitted infections (STIs).","risk_presentation":"the frequent scene changes and attention-grabbing visuals (e.g., the sexually suggestive behaviors described above) during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Apretude. FDA said it misleadingly suggested sexual freedom without the need for safer sex to reduce STI risk, and that frequent scene changes and attention-grabbing visuals interfered with comprehension of the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/189906/download?attachment","promo":[{"url":"https://www.fda.gov/media/189907/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-12","closeoutUrl":"https://www.fda.gov/media/190308/download?attachment","closeoutKnown":true,"closeoutDays":94,"words":880,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"glaxosmithkline-apretude-2025-09-09"},{"id":"u188706","type":"untitled","date":"2025-09-09","company":"Galderma","listedAs":"Galderma Laboratories, L.P.","brand":"NEMLUVIO","generic":"nemolizumab-ilto","product":"NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use","appType":"BLA","appNumber":"761391","matter":"57","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad 'Scratch Resistance'","categories":["efficacy_claims","broader_use"],"quotes":{"broader_use":"the claims and presentations above suggest that Nemluvio can be used alone for the treatment of moderate-to-severe atopic dermatitis, when this is not the case.","efficacy_claims":"the claims and presentations above imply that treatment with Nemluvio provides itch relief as soon as 48 hours after treatment initiation, when this has not been demonstrated."},"summary":"A direct-to-consumer TV ad for Nemluvio suggested the drug could be used alone for eczema, although it is indicated with topical treatments. FDA also said the ad overstated itch relief within 48 hours and lasting clear skin.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188706/download?attachment","promo":[],"closeoutDate":"2026-01-21","closeoutUrl":"https://www.fda.gov/media/190863/download?attachment","closeoutKnown":true,"closeoutDays":134,"words":1295,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"galderma-nemluvio-2025-09-09"},{"id":"u188902","type":"untitled","date":"2025-09-09","company":"Evolus","listedAs":"Evolus, Inc.","brand":"JEUVEAU","generic":"prabotulinumtoxina-xvfs","product":"JEUVEAU® (prabotulinumtoxinA-xvfs) for injection, for intramuscular use","appType":"BLA","appNumber":"761085","matter":"559","audience":"professional","channels":["other"],"piece":"Professional newsletter 'Science Behind Jeuveau'","categories":["risk_omission","efficacy_claims","superiority"],"quotes":{"superiority":"We are not aware of any head-to-head studies comparing Jeuveau to other botulinum toxin products for this use that could be used to support claims that Jeuveau has any unique or added benefits","efficacy_claims":"These claims are not supported by the cited review article1 that summarizes various manufacturing processes and describes in vitro, in vivo and clinical studies.","risk_omission":"Thus, the newsletter minimizes the risk of immunogenicity with Jeuveau treatment and misleadingly suggests Jeuveau offers additional benefits compared to other botulinum products due to manufacturing processes."},"summary":"A professional newsletter for Jeuveau suggested that its manufacturing process and formulation gave it benefits over other botulinum toxin products. FDA said these claims lacked head-to-head evidence and that the newsletter minimized the risks of distant toxin spread and immunogenicity.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188902/download?attachment","promo":[{"url":"https://www.fda.gov/media/188910/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-19","closeoutUrl":"https://www.fda.gov/media/189737/download?attachment","closeoutKnown":true,"closeoutDays":71,"words":1346,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"evolus-jeuveau-2025-09-09"},{"id":"weli-lilly-and-company-716485-09092025","type":"warning","date":"2025-09-09","company":"Eli Lilly","listedAs":"","brand":"Zepbound and Mounjaro","generic":"tirzepatide","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Video 'An Oprah Special: Shame, Blame, and the Weight Loss Revolution'","categories":["risk_omission","risk_presentation","form_2253"],"quotes":{"risk_omission":"the video omits an important concept from the boxed warning for both drugs; specifically the contraindication in patients with a personal or family history of MEN 2 due to the risk of thyroid c-cell tumors.","risk_presentation":"the video is also misleading because it fails to present information related to side effects and contraindications for Zepbound and Mounjaro with a prominence and readability reasonably comparable","form_2253":"these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A direct-to-consumer TV special video featuring paid consultants and a company executive discussed Zepbound and Mounjaro. FDA said it left out boxed warning and other serious risks, played down side effects as overhyped and mild, and was not submitted at first use.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716485-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":2992,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"eli-lilly-zepbound-and-mounjaro-2025-09-09"},{"id":"weli-lilly-and-company-716475-09092025","type":"warning","date":"2025-09-09","company":"Eli Lilly","listedAs":"","brand":"Zepbound","generic":"tirzepatide","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Online news video interview with Eli Lilly representatives","categories":["risk_omission","missing_disclosure","form_2253"],"quotes":{"risk_omission":"By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety.","missing_disclosure":"By failing to disclose the limitations of use associated with Zepbound, the video creates a misleading suggestion about the FDA-approved indication and use for Zepbound.","form_2253":"A copy of the video was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A direct-to-consumer online video interview with Eli Lilly representatives about Zepbound made benefit claims but omitted all risk information and the limitations of use. It was also not submitted to FDA on Form FDA-2253 at first publication.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716475-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1860,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"eli-lilly-zepbound-2025-09-09-2"},{"id":"weli-lilly-and-company-716462-09092025","type":"warning","date":"2025-09-09","company":"Eli Lilly","listedAs":"","brand":"ZEPBOUND","generic":"tirzepatide","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Sponsored online video interview with Eli Lilly representatives on okcfox.com","categories":["risk_omission","missing_disclosure","form_2253"],"quotes":{"risk_omission":"By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety.","missing_disclosure":"By failing to disclose the limitations of use associated with Zepbound, the video creates a misleading suggestion about the FDA-approved indication and use for Zepbound.","form_2253":"A copy of the video was not submitted to OPDP under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A sponsored online video interview with two Eli Lilly representatives promoted Zepbound. FDA said it made benefit claims while omitting all risk information, omitted the limitations of use, and was not submitted on Form FDA-2253 at first publication.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716462-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1863,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"eli-lilly-zepbound-2025-09-09"},{"id":"wcsl-behring-716297-09092025","type":"warning","date":"2025-09-09","company":"CSL Behring","listedAs":"","brand":"HIZENTRA","generic":"immune globulin subcutaneous (human)","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad 'Live in Strength: Supermarket'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The overall impression of this DTC TV ad, including its imagery and the above statements, misleadingly overstates the efficacy of HIZENTRA.","risk_presentation":"The presentation of limitations and risk information in the DTC TV ad is not reasonably comparable to the presentation of benefits."},"summary":"A direct-to-consumer TV ad showed a treated woman shielded from all germs in a supermarket. FDA said it overstated efficacy and that fast pacing, distracting visuals and small, low-contrast text undermined the risk information and the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/csl-behring-716297-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1490,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"csl-behring-hizentra-2025-09-09"},{"id":"u188707","type":"untitled","date":"2025-09-09","company":"Bristol Myers Squibb","listedAs":"Bristol-Myers Squibb","brand":"Opdivo Qvantig","generic":"nivolumab and hyaluronidase-nvhy","product":"OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use","appType":"BLA","appNumber":"761381","matter":"116","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (1992-US-2500295)","categories":["risk_presentation","dosing_convenience"],"quotes":{"dosing_convenience":"The totality of these representations makes the TV ad misleading by suggesting that patients receiving Opdivo Qvantig will spend little to no time in a clinical setting","risk_presentation":"during the presentation of the major statement interfere with the comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Opdivo Qvantig suggested patients would spend little to no time in a clinical setting. FDA also said attention-grabbing visuals and frequent scene changes during the major statement interfered with comprehension of the risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188707/download?attachment","promo":[],"closeoutDate":"2025-12-11","closeoutUrl":"https://www.fda.gov/media/190158/download?attachment","closeoutKnown":true,"closeoutDays":93,"words":814,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bristol-myers-squibb-opdivo-qvantig-2025-09-09"},{"id":"u188708","type":"untitled","date":"2025-09-09","company":"Bristol Myers Squibb","listedAs":"Bristol-Myers Squibb","brand":"Opdivo and Yervoy","generic":"nivolumab and ipilimumab","product":"OPDIVO® (nivolumab) injection, for intravenous use YERVOY® (ipilimumab) injection, for intravenous use","appType":"BLA","appNumber":"125554","matter":"5220","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad (1506-US-2400730) featuring three patient 'heroes'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"the TV ad is misleading by suggesting that treatment with Opdivo plus Yervoy will positively impact a patient's health-related quality of life (HRQoL)","risk_presentation":"during the presentation of the major statement interfere with the comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Opdivo plus Yervoy in advanced non-small cell lung cancer. FDA said it overstated patients' functioning and quality-of-life benefits without supporting data, and that distracting visuals interfered with the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188708/download?attachment","promo":[],"closeoutDate":"2025-12-11","closeoutUrl":"https://www.fda.gov/media/190159/download?attachment","closeoutKnown":true,"closeoutDays":93,"words":993,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bristol-myers-squibb-opdivo-and-yervoy-2025-09-09"},{"id":"u188699","type":"untitled","date":"2025-09-09","company":"Bristol Myers Squibb","listedAs":"Bristol Myers Squibb","brand":"CAMZYOS","generic":"mavacamten","product":"CAMZYOS® (mavacamten) capsules for oral use","appType":"NDA","appNumber":"214998","matter":"432","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'Feel/See Basketball'","categories":["risk_omission","risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"Therefore, claims and presentations implying that all patients can reasonably expect to perform this level of activity or functioning while being on treatment with Camzyos are misleading.","risk_omission":"By omitting this material risk information, the TV ad minimizes the warning and precaution for embryo-fetal toxicity and creates a misleading impression of the drug’s safety.","risk_presentation":"the size and style of font, contrast with background, and placement on screen of the text portion of the major statement, do not allow the information to be read easily."},"summary":"A 60-second direct-to-consumer TV ad for Camzyos suggested that all patients with obstructive HCM could do vigorous activities, and it misrepresented how the drug works. FDA also said the ad left out embryo-fetal toxicity risk and that its major statement was hard to read.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188699/download?attachment","promo":[{"url":"https://www.fda.gov/media/188700/download?attachment","format":"PDF"}],"closeoutDate":"2026-03-18","closeoutUrl":"https://www.fda.gov/media/191777/download?attachment","closeoutKnown":true,"closeoutDays":190,"words":1352,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bristol-myers-squibb-camzyos-2025-09-09"},{"id":"u188687","type":"untitled","date":"2025-09-09","company":"BridgeBio Pharma","listedAs":"BridgeBio Pharma, Inc.","brand":"ATTRUBY","generic":"acoramidis","product":"ATTRUBY® (acoramidis) tablets","appType":"NDA","appNumber":"216540","matter":"74","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer broadcast TV ad (MAT-US-ACO-0617)","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The totality of these claims and presentations also misleadingly suggests that treatment with Attruby will broadly improve a patient’s overall quality of life when this has not been demonstrated."},"summary":"A direct-to-consumer TV ad for Attruby suggested patients could live carefree, return to life before their ATTR-CM diagnosis, and broadly improve their quality of life. FDA said trial data showed only a slower decline, not improvement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188687/download?attachment","promo":[{"url":"https://www.fda.gov/media/188688/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-20","closeoutUrl":"https://www.fda.gov/media/189803/download?attachment","closeoutKnown":true,"closeoutDays":72,"words":1036,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bridgebio-pharma-attruby-2025-09-09"},{"id":"u188748","type":"untitled","date":"2025-09-09","company":"Boehringer Ingelheim","listedAs":"Boehringer Ingelheim Pharmaceuticals, Inc.","brand":"JARDIANCE","generic":"empagliflozin","product":"JARDIANCE® (empagliflozin tablets), for oral use","appType":"NDA","appNumber":"204629","matter":"3988","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad set in a supermarket with singing and dancing","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"distract the viewer from important information about the benefits of Jardiance and, therefore, creates a misleading impression about the drug’s efficacy.","risk_presentation":"the size and style of font, contrast with background, and placement on screen of the text portion of the major statement, do not allow the information to be read easily"},"summary":"A direct-to-consumer TV ad for Jardiance showed singing and dancing in a supermarket. FDA said the distracting visuals and music undermined the indication and limitations of use, and that the major statement's text was hard to read and competed with attention-grabbing visuals.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188748/download?attachment","promo":[],"closeoutDate":"2025-12-01","closeoutUrl":"https://www.fda.gov/media/190402/download?attachment","closeoutKnown":true,"closeoutDays":83,"words":798,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"boehringer-ingelheim-jardiance-2025-09-09-3"},{"id":"u188747","type":"untitled","date":"2025-09-09","company":"Boehringer Ingelheim","listedAs":"Boehringer Ingelheim Pharmaceuticals, Inc.","brand":"JARDIANCE","generic":"empagliflozin","product":"JARDIANCE® (empagliflozin tablets), for oral use","appType":"NDA","appNumber":"204629","matter":"4131","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad 'jardiancet2dbigstorysoftball75syoutubeolv-cm'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"distract the viewer from important information about the benefits of Jardiance and, therefore, creates a misleading impression about the drug’s efficacy.","risk_presentation":"the size and style of font, contrast with background, and placement on screen of the text portion of the major statement, do not allow the information to be read easily."},"summary":"A direct-to-consumer TV ad for Jardiance used fast-paced softball and dancing visuals that FDA said distracted from the indication and limitations of use. FDA also said the major statement text was hard to read and undermined by competing visuals.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188747/download?attachment","promo":[],"closeoutDate":"2025-12-01","closeoutUrl":"https://www.fda.gov/media/190400/download?attachment","closeoutKnown":true,"closeoutDays":83,"words":816,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"boehringer-ingelheim-jardiance-2025-09-09-2"},{"id":"u188746","type":"untitled","date":"2025-09-09","company":"Boehringer Ingelheim","listedAs":"Boehringer Ingelheim Pharmaceuticals, Inc.","brand":"JARDIANCE","generic":"empagliflozin","product":"JARDIANCE® (empagliflozin tablets), for oral use","appType":"NDA","appNumber":"204629","matter":"4235","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad 'jardiancetdtvspot6movienight-cm'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"competing presentational aspects that distract the viewer from important information about the benefits of Jardiance and, therefore, creates a misleading impression about the drug’s efficacy","risk_presentation":"the size and style of font, contrast with background, and placement on screen of the text portion of the major statement, do not allow the information to be read easily"},"summary":"A direct-to-consumer TV ad for Jardiance used fast-paced, distracting movie-night visuals and music that undermined the indication and limitations of use, and it presented the major statement in hard-to-read text alongside competing visuals.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188746/download?attachment","promo":[],"closeoutDate":"2025-12-01","closeoutUrl":"https://www.fda.gov/media/190401/download?attachment","closeoutKnown":true,"closeoutDays":83,"words":792,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"boehringer-ingelheim-jardiance-2025-09-09"},{"id":"u188749","type":"untitled","date":"2025-09-09","company":"Bausch Health","listedAs":"Bausch Health Companies Inc.","brand":"JUBLIA","generic":"efinaconazole","product":"JUBLIA® (efinaconazole) topical solution, 10% for topical use","appType":"NDA","appNumber":"203567","matter":"852","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad (JUB.0058.USA.24)","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"The TV ad is misleading because it creates a misleading impression that all patients, once treated with Jublia, can expect a complete cure, when this has not been demonstrated.","dosing_convenience":"the TV ad is misleading because it creates the impression that Jublia can offer immediate results treating onychomycosis, when this has not been demonstrated."},"summary":"A direct-to-consumer TV ad for Jublia used a Bigfoot foot portrayal and the line don't fear the fungus. FDA objected that the ad implied a complete cure for all patients and immediate results, which the clinical data do not support.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188749/download?attachment","promo":[{"url":"https://www.fda.gov/media/188742/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-19","closeoutUrl":"https://www.fda.gov/media/189736/download?attachment","closeoutKnown":true,"closeoutDays":71,"words":1054,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"bausch-health-jublia-2025-09-09"},{"id":"u188703","type":"untitled","date":"2025-09-09","company":"Azurity Pharmaceuticals","listedAs":"Azurity Pharmaceuticals, Inc.","brand":"DANZITEN","generic":"nilotinib","product":"DANZITEN (nilotinib) tablets, for oral use","appType":"NDA","appNumber":"219293","matter":"71","audience":"both","channels":["tv_ad","online_video"],"piece":"TV skin/background (PP-DAN-US-0177) and video (PP-DAN-US-0172)","categories":["risk_omission","risk_presentation","broader_use","missing_disclosure"],"quotes":{"risk_omission":"the background and video completely omit information regarding the warnings and precautions for cardiac and arterial vascular occlusive events, tumor lysis syndrome, hemorrhage, fluid retention, and embryo-fetal toxicity","risk_presentation":"the presentation of risk information in the video does not appear in a sequence that discloses risk information in the order of severity, and thus misleadingly minimizes the risks associated with Danziten","missing_disclosure":"The background and video are misleading because they fail to provide material information regarding Danziten’s full FDA-approved indication.","broader_use":"the video suggests that Danziten is for patients in chronic or accelerated phase CML after intolerance or resistance to any prior therapy"},"summary":"A professional and consumer TV background and a video for Danziten left out major warnings, such as cardiac events, hemorrhage and embryo-fetal toxicity. They also listed risks out of order of severity and misstated the approved indication.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188703/download?attachment","promo":[{"url":"https://www.fda.gov/media/188704/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-03","closeoutUrl":"https://www.fda.gov/media/190083/download?attachment","closeoutKnown":true,"closeoutDays":85,"words":889,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"azurity-pharmaceuticals-danziten-2025-09-09"},{"id":"waytu-biopharma-716604-09092025","type":"warning","date":"2025-09-09","company":"Aytu Biopharma","listedAs":"","brand":"Cotempla XR-ODT","generic":"methylphenidate","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["search_ad"],"piece":"Google sponsored search links for Cotempla XR-ODT","categories":["risk_omission","efficacy_claims","missing_disclosure","form_2253"],"quotes":{"risk_omission":"The sponsored links are misleading because they include representations about the efficacy of Cotempla XR-ODT but fail to communicate any risk information.","efficacy_claims":"The sponsored links for Cotempla XR-ODT include misleading representations about its efficacy","missing_disclosure":"The sponsored links fail to present the established name for Cotempla XR-ODT, thereby misbranding the product.","form_2253":"A copy of the sponsored links was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"Google sponsored search links for Cotempla XR-ODT made efficacy claims without any risk information. They called the drug an equivalent substitute for Concerta, which has not been shown. They also left out the established name and were not submitted on Form FDA-2253.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aytu-biopharma-716604-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1852,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"aytu-biopharma-cotempla-xr-odt-2025-09-09"},{"id":"waytu-biopharma-716599-09092025","type":"warning","date":"2025-09-09","company":"Aytu Biopharma","listedAs":"","brand":"Adzenys XR-ODT","generic":"amphetamine","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["search_ad"],"piece":"Google sponsored search links for Adzenys XR-ODT","categories":["risk_omission","missing_disclosure","form_2253"],"quotes":{"risk_omission":"The sponsored links are misleading because they include representations about the efficacy of Adzenys XR-ODT but fail to communicate any risk information.","missing_disclosure":"The sponsored links fail to present the established name for Adzenys XR-ODT, thereby misbranding the product.","form_2253":"A copy of the sponsored links was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"Google sponsored search links for Adzenys XR-ODT made efficacy claims but gave no risk information and left out the established name. They were also not submitted to FDA on Form FDA-2253 when first published.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aytu-biopharma-716599-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1402,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"aytu-biopharma-adzenys-xr-odt-2025-09-09"},{"id":"u188689","type":"untitled","date":"2025-09-09","company":"Axsome Therapeutics","listedAs":"Axsome Therapeutics, Inc.","brand":"AUVELITY","generic":"dextromethorphan hydrobromide and bupropion hydrochloride","product":"AUVELITY® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral use","appType":"NDA","appNumber":"215430","matter":"148","audience":"consumer","channels":["print_ad"],"piece":"DTC print advertisement (PP-AUV-US-2400051)","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"create a misleading representation that treatment with Auvelity will provide a specific benefit of improving symptoms of anhedonia in patients with MDD, allowing patients to feel pleasure and joy, when this benefit has not been demonstrated."},"summary":"A direct-to-consumer print ad for Auvelity claimed it improves anhedonia in patients with major depressive disorder. FDA said the claims rested on an unvalidated post hoc subscale analysis, so they misleadingly implied a benefit that has not been demonstrated.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188689/download?attachment","promo":[{"url":"https://www.fda.gov/media/188690/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-15","closeoutUrl":"https://www.fda.gov/media/190569/download?attachment","closeoutKnown":true,"closeoutDays":97,"words":1116,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"axsome-therapeutics-auvelity-2025-09-09"},{"id":"u188712","type":"untitled","date":"2025-09-09","company":"AstraZeneca","listedAs":"AstraZeneca Pharmaceuticals LP","brand":"TRUQAP","generic":"capivasertib","product":"TRUQAP® (capivasertib) tablets, for oral use","appType":"NDA","appNumber":"218197","matter":"169","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad '2025 TRUQAP Branded Patient TV Spot'","categories":["risk_presentation"],"quotes":{"risk_presentation":"The TV ad is misleading because the frequent scene changes, some with compelling and attention-\ngrabbing visuals, during the presentation of the major statement interfere with comprehension\nof the major statement."},"summary":"A direct-to-consumer TV ad for Truqap. FDA said frequent scene changes and attention-grabbing visuals during the major statement interfere with comprehension of the risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188712/download?attachment","promo":[],"closeoutDate":"2025-11-21","closeoutUrl":"https://www.fda.gov/media/190592/download?attachment","closeoutKnown":true,"closeoutDays":73,"words":573,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-truqap-2025-09-09"},{"id":"u188733","type":"untitled","date":"2025-09-09","company":"AstraZeneca","listedAs":"AstraZeneca Pharmaceuticals LP","brand":"FASENRA","generic":"benralizumab","product":"FASENRA® (benralizumab) injection, for subcutaneous use","appType":"BLA","appNumber":"761070","matter":"1274","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'FASENRA Rachel's Story – End card update'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The totality of these claims and presentations misleadingly suggests that Fasenra provides greater benefits to patients ages 6 years and older with severe asthma, and with an eosinophilic phenotype than has been demonstrated.","risk_presentation":"Therefore, the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer TV ad featured a patient's before-and-after story. FDA said it overstated how much and how long Fasenra improves asthma control and social and emotional functioning, and that its major statement left out hypersensitivity audio and lacked dual modality.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188733/download?attachment","promo":[],"closeoutDate":"2026-02-11","closeoutUrl":"https://www.fda.gov/media/191216/download?attachment","closeoutKnown":true,"closeoutDays":155,"words":1228,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-fasenra-2025-09-09-3"},{"id":"u188732","type":"untitled","date":"2025-09-09","company":"AstraZeneca","listedAs":"AstraZeneca Pharmaceuticals LP","brand":"FASENRA","generic":"benralizumab","product":"FASENRA® (benralizumab) injection, for subcutaneous use","appType":"BLA","appNumber":"761070","matter":"1150","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'FASENRA TV 30 Frisbee'","categories":["risk_omission","risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"misleadingly suggests that Fasenra provides greater benefits to patients ages 6 years and older with severe asthma, and with an eosinophilic phenotype than has been demonstrated","risk_omission":"The TV ad is misleading because it fails to include material information in the major statement about the advertised drug in the manner required for TV ads for human prescription drugs.","risk_presentation":"Therefore, the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality)."},"summary":"A direct-to-consumer TV ad for Fasenra implied that it improves social and emotional functioning, which goes beyond the evidence. FDA also said the ad's audio major statement left out the hypersensitivity information and that the major statement was not presented in both audio and text.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188732/download?attachment","promo":[],"closeoutDate":"2026-02-11","closeoutUrl":"https://www.fda.gov/media/191203/download?attachment","closeoutKnown":true,"closeoutDays":155,"words":994,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-fasenra-2025-09-09-2"},{"id":"u188717","type":"untitled","date":"2025-09-09","company":"AstraZeneca","listedAs":"AstraZeneca Pharmaceuticals LP","brand":"FASENRA","generic":"benralizumab","product":"FASENRA® (benralizumab) injection, for subcutaneous use","appType":"BLA","appNumber":"761070","matter":"1157","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'FASENRA TV 30 SALSA'","categories":["risk_omission","risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"The totality of these claims and presentations misleadingly suggests that Fasenra provides greater benefits to patients ages 6 years and older with severe asthma, and with an eosinophilic phenotype than has been demonstrated.","risk_omission":"The TV ad is misleading because it fails to include material information in the major statement about the advertised drug in the manner required for TV ads for human prescription drugs.","risk_presentation":"the TV ad is misleading because the attention-grabbing visuals and background music (i.e., fast-paced salsa dancing and music) during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Fasenra used social media scenes of a woman salsa dancing. FDA said the ad overstated social and emotional benefits, left hypersensitivity information out of the audio major statement, lacked dual modality, and used visuals that distracted from risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188717/download?attachment","promo":[{"url":"https://www.fda.gov/media/188718/download?attachment","format":"PDF"}],"closeoutDate":"2026-02-11","closeoutUrl":"https://www.fda.gov/media/191215/download?attachment","closeoutKnown":true,"closeoutDays":155,"words":1085,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-fasenra-2025-09-09"},{"id":"u188697","type":"untitled","date":"2025-09-09","company":"AstraZeneca","listedAs":"AstraZeneca Pharmaceuticals LP","brand":"CALQUENCE","generic":"acalabrutinib","product":"CALQUENCE® (acalabrutinib) capsules, for oral use","appType":"NDA","appNumber":"216387","matter":"824","audience":"consumer","channels":["tv_ad"],"piece":"TV ad '2025 CALQUENCE DTC Commercial - Major Statement Update'","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"misleading impression that patients on Calquence can maintain a normal, active lifestyle\nwhile undergoing treatment, thereby downplaying the serious side effects and monitoring\nrequirements.","risk_presentation":"couple goes sightseeing during the presentation of the major statement interfere with\ncomprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Calquence showed patients living active lives. FDA said this misleadingly played down the drug's serious side effects and monitoring requirements, and that distracting visuals during the major statement interfered with comprehension of the risks.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188697/download?attachment","promo":[{"url":"https://www.fda.gov/media/188698/download?attachment","format":"PDF"}],"closeoutDate":"2025-12-16","closeoutUrl":"https://www.fda.gov/media/190307/download?attachment","closeoutKnown":true,"closeoutDays":98,"words":768,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-calquence-2025-09-09"},{"id":"u188705","type":"untitled","date":"2025-09-09","company":"ARS Pharmaceuticals","listedAs":"ARS Pharmaceutical Operations, Inc.","brand":"NEFFY","generic":"epinephrine nasal spray","product":"NEFFY® (epinephrine nasal spray)","appType":"NDA","appNumber":"214697","matter":"136","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer broadcast TV ad (NEF-US-0507-1)","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These claims also misleadingly suggest that Neffy will eliminate patients’ concerns in terms of needle fear when this has not been demonstrated."},"summary":"A direct-to-consumer TV ad for Neffy suggested that patients could avoid all needles, would lose their fear of needles, and could stop worrying about allergen exposure. FDA said none of these benefits had been demonstrated.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188705/download?attachment","promo":[],"closeoutDate":"2026-06-16","closeoutUrl":"https://www.fda.gov/media/193227/download?attachment","closeoutKnown":true,"closeoutDays":280,"words":863,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"ars-pharmaceuticals-neffy-2025-09-09"},{"id":"u188901","type":"untitled","date":"2025-09-09","company":"Amgen","listedAs":"Amgen Inc.","brand":"IMDELLTRA","generic":"tarlatamab-dlle","product":"IMDELLTRA™ (tarlatamab-dlle) for injection, for intravenous use","appType":"BLA","appNumber":"761344","matter":"54","audience":"professional","channels":["website"],"piece":"“ORR” webpage on IMDELLTRA Healthcare Provider Branded Website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"Consequently, the presentation of the “depth of response” achieved by patients treated with Imdelltra, which includes SD data, is not supported by the data cited."},"summary":"An ORR webpage on the Imdelltra healthcare provider website showed a waterfall plot of depth of response that included stable disease data. FDA said the single-arm trial cannot show that stable disease results came from the drug, and that the disclaimer did not correct this.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188901/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":1152,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"amgen-imdelltra-2025-09-09"},{"id":"walora-pharmaceuticals-716591-09092025","type":"warning","date":"2025-09-09","company":"Alora Pharmaceuticals","listedAs":"","brand":"RELEXXII","generic":"methylphenidate hydrochloride","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["search_ad"],"piece":"Google sponsored links 'Alora Pharmaceuticals Relexxii Paid Search Campaign'","categories":["risk_omission"],"quotes":{"risk_omission":"The sponsored links are misleading because they include representations about the efficacy of Relexxii but fail to communicate any risk information."},"summary":"Google paid search sponsored links for Relexxii made efficacy claims about once-daily, tailored ADHD treatment but included no risk information. FDA said this created a misleading impression of the drug's safety, despite a referral to the website.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alora-pharmaceuticals-716591-09092025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1321,"citesStatute":true,"asks15Days":true,"warnsEnforcement":true,"slug":"alora-pharmaceuticals-relexxii-2025-09-09"},{"id":"u188686","type":"untitled","date":"2025-09-09","company":"Alnylam Pharmaceuticals","listedAs":"Alnylam Pharmaceuticals, Inc.","brand":"AMVUTTRA","generic":"vutrisiran","product":"AMVUTTRA® (vutrisiran) injection, for subcutaneous use","appType":"NDA","appNumber":"215515","matter":"257","audience":"consumer","channels":["tv_ad"],"piece":"DTC broadcast TV ad (AMV-USA-00862)","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"The totality of these claims and presentations also misleadingly suggests that treatment with Amvuttra will broadly improve a patient’s overall quality of life when this has not been demonstrated.","dosing_convenience":"By omitting material information explaining these timeframes, the TV ad misleadingly suggests that Amvuttra has a faster onset of effect than what has been demonstrated."},"summary":"A direct-to-consumer TV ad for Amvuttra suggested that patients with ATTR-CM could live carefree or as before their diagnosis, with broadly improved quality of life. FDA said this was not demonstrated and that the ad overstated how quickly the drug takes effect.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188686/download?attachment","promo":[],"closeoutDate":"2025-11-20","closeoutUrl":"https://www.fda.gov/media/189804/download?attachment","closeoutKnown":true,"closeoutDays":72,"words":1134,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"alnylam-pharmaceuticals-amvuttra-2025-09-09"},{"id":"u188731","type":"untitled","date":"2025-09-09","company":"Alexion Pharmaceuticals","listedAs":"Alexion Pharmaceuticals, Inc.","brand":"ULTOMIRIS","generic":"ravulizumab-cwvz","product":"ULTOMIRIS® (ravulizumab-cwvz) injection, for intravenous use","appType":"BLA","appNumber":"761108","matter":"972","audience":"consumer","channels":["tv_ad"],"piece":"DTC TV ad 'ULTOMIRIS gMG DTC TV Spot – 2025 2_(v1.0)'","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"These claims and presentations misleadingly suggest that Ultomiris provides treatment\nbenefits beyond what has been demonstrated.","risk_presentation":"frequent scene changes during the presentation of the major\nstatement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Ultomiris in generalized myasthenia gravis. FDA said its continuous symptom control and daily activity claims overstated the trial evidence, and that distracting visuals and frequent scene changes interfered with comprehension of the major statement.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188731/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":true,"closeoutDays":null,"words":861,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"alexion-pharmaceuticals-ultomiris-2025-09-09"},{"id":"u188908","type":"untitled","date":"2025-09-09","company":"AbbVie","listedAs":"AbbVie, Inc.","brand":"SKYRIZI","generic":"risankizumab-rzaa","product":"SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous or intravenous use","appType":"BLA","appNumber":"761105","matter":"2876","audience":"professional","channels":["website"],"piece":"\"SKYRIZI VS STELARA (ustekinumab)\" webpage on HCP branded website","categories":["efficacy_claims","superiority"],"quotes":{"superiority":"These claims misleadingly represent that Skyrizi has been shown to be superior to Stelara in the treatment of patients with moderately to severely active Crohn’s disease.","efficacy_claims":"SEQUENCE was inadequately designed to support conclusory representations that Skyrizi is superior to Stelara."},"summary":"A healthcare provider webpage compared Skyrizi with Stelara in Crohn's disease. FDA said its superiority claims were not supported because the open-label SEQUENCE study had bias, unequal dropout and missing assessments, and a data limitation statement did not cure this.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188908/download?attachment","promo":[{"url":"https://www.fda.gov/media/188897/download?attachment","format":"PDF"}],"closeoutDate":"2026-02-13","closeoutUrl":"https://www.fda.gov/media/191202/download?attachment","closeoutKnown":true,"closeoutDays":157,"words":1306,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"abbvie-skyrizi-2025-09-09"},{"id":"u188729","type":"untitled","date":"2025-09-09","company":"AbbVie","listedAs":"AbbVie, Inc.","brand":"Qulipta","generic":"atogepant","product":"QULIPTA® (atogepant) tablets, for oral use","appType":"NDA","appNumber":"215206","matter":"903","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer TV ad (US-QLP-250169)","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"These claims and compelling before-and-after presentation misleadingly create an impression of total migraine prevention when this has not been demonstrated.","risk_presentation":"during the presentation of the major statement interferes with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Qulipta. FDA said its claims and before-and-after visuals implied total migraine prevention, which the trial data do not support, and that distracting visuals during the major statement interfered with comprehension of the risk information.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/188729/download?attachment","promo":[{"url":"https://www.fda.gov/media/188730/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-28","closeoutUrl":"https://www.fda.gov/media/191765/download?attachment","closeoutKnown":true,"closeoutDays":80,"words":857,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"abbvie-qulipta-2025-09-09"},{"id":"u188750","type":"untitled","date":"2025-09-09","company":"AbbVie","listedAs":"AbbVie, Inc.","brand":"LINZESS","generic":"linaclotide","product":"LINZESS® (linaclotide) capsules, for oral use","appType":"NDA","appNumber":"202811","matter":"1615","audience":"consumer","channels":["tv_ad"],"piece":"Direct-to-consumer broadcast TV ad (US-LIN-240235)","categories":["risk_presentation"],"quotes":{"risk_presentation":"The TV ad is misleading because the frequent scene changes and compelling and attention-grabbing visuals during the presentation of the major statement interfere with comprehension of the major statement."},"summary":"A direct-to-consumer TV ad for Linzess. FDA said its frequent scene changes and attention-grabbing visuals during the major statement interfered with comprehension of the risk information.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188750/download?attachment","promo":[{"url":"https://www.fda.gov/media/188743/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-25","closeoutUrl":"https://www.fda.gov/media/190310/download?attachment","closeoutKnown":true,"closeoutDays":77,"words":621,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"abbvie-linzess-2025-09-09"},{"id":"u188963","type":"untitled","date":"2025-09-09","company":"Aadi Bioscience","listedAs":"Aadi Bioscience","brand":"FYARRO","generic":"sirolimus protein-bound particles for injectable suspension (albumin-bound)","product":"FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albuminbound), for intravenous use","appType":"NDA","appNumber":"213312","matter":"48","audience":"professional","channels":["website"],"piece":"'Efficacy Data' webpage on FYARRO Branded Healthcare Provider Website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These representations of SD and DCR make this promotional communication misleading by suggesting that Fyarro improves SD and DCR in patients with locally advanced or metastatic malignant perivascular epithelioid cell tumor"},"summary":"An Efficacy Data webpage on the Fyarro healthcare provider website presented stable disease, disease control rate, progression-free survival and overall survival results from a single-arm trial. FDA said that trial design could not support these efficacy representations.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/188963/download?attachment","promo":[{"url":"https://www.fda.gov/media/188964/download?attachment","format":"PDF"}],"closeoutDate":"2025-11-17","closeoutUrl":"https://www.fda.gov/media/189938/download?attachment","closeoutKnown":true,"closeoutDays":69,"words":1588,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"aadi-bioscience-fyarro-2025-09-09"},{"id":"wsprout-pharmaceuticals-inc-709942-05292025","type":"warning","date":"2025-05-29","company":"Sprout Pharmaceuticals","listedAs":"","brand":"Addyi","generic":"flibanserin","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["social_media","spokesperson"],"piece":"CEO Instagram post on account cindypinkceo with People.com screenshot","categories":["risk_omission","broader_use","missing_disclosure","form_2253"],"quotes":{"risk_omission":"The post is misleading because it includes representations about the benefits of Addyi but fails to communicate any risk information.","missing_disclosure":"The post is misleading because it fails to provide material information regarding Addyi’s full FDA-approved indication, including important limitations of use.","broader_use":"This broad claim suggests that Addyi is indicated, among other things, to enhance sexual performance, which is particularly concerning given the limitations of use and serious risks of this product.","form_2253":"A copy of the post was not submitted to OPDP under cover of Form FDA-2253 at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"An Instagram post by Sprout's CEO promoted Addyi. FDA said the post made benefit claims without any risk information. It also left out the full indication and limitations of use, and the post was not submitted on Form FDA-2253.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-709942-05292025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1940,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"sprout-pharmaceuticals-addyi-2025-05-29"},{"id":"u186470","type":"untitled","date":"2025-04-28","company":"Mayne Pharma","listedAs":"Mayne Pharma LLC","brand":"NEXTSTELLIS","generic":"drospirenone and estetrol","product":"NEXTSTELLIS (drospirenone and estetrol tablets), for oral use","appType":"NDA","appNumber":"214154","matter":"107","audience":"professional","channels":["speaker_program"],"piece":"Speaker deck for Nextstellis promotional programs with speaker notes","categories":["risk_omission","efficacy_claims","superiority"],"quotes":{"risk_omission":"the risk presentation on slides 34-38 omits material facts regarding the risks of hyperkalemia, migraine, and bleeding irregularities and amenorrhea associated with Nextstellis.","superiority":"These claims and presentations misleadingly suggest that Nextstellis is “unique” and intrinsically different from other estrogens, making Nextstellis a safer form of estrogen-containing oral contraception due to its “low-impact” properties.","efficacy_claims":"This claim is misleading because it is based on data that are inadequate to support such conclusions."},"summary":"A professional speaker deck for Nextstellis promotional programs suggested that estetrol makes it safer than other combined hormonal contraceptives. FDA said it played down liver, metabolic, clotting, breast and bleeding risks, left out risk information, and overstated exploratory bleeding-pattern data.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/186470/download?attachment","promo":[{"url":"https://www.fda.gov/media/186471/download?attachment","format":"PDF"}],"closeoutDate":"2025-06-02","closeoutUrl":"https://www.fda.gov/media/187014/download?attachment","closeoutKnown":true,"closeoutDays":35,"words":4163,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"mayne-pharma-nextstellis-2025-04-28"},{"id":"wsarfez-pharmaceuticals-inc-708901-04252025","type":"warning","date":"2025-04-25","company":"Sarfez","listedAs":"","brand":"SOAANZ","generic":"torsemide","product":"","appType":"","appNumber":"","matter":"","audience":"both","channels":["website","online_video","brochure","exhibit"],"piece":"Soaanz webpages, healthcare provider pamphlet, and ACC exhibit booth panel","categories":["risk_omission","efficacy_claims","superiority","broader_use","form_2253"],"quotes":{"efficacy_claims":"misleadingly represent that Soaanz has shown a benefit regarding natriuretic efficacy, when this has not been demonstrated.","superiority":"misleadingly suggest that Soaanz is superior to generic loop diuretics due to its pharmacologic profile, when this has not been demonstrated.","risk_omission":"By omitting the risks associated with Soaanz, the exhibit panel fails to provide material information about the consequences that may result from the use of Soaanz","broader_use":"This claim omits material information from the full FDA-approved indication for Soaanz and misleadingly represents Soaanz’s effectiveness in heart failure patients.","form_2253":"were not submitted to OPDP under cover of Form FDA-2253 at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"Two Soaanz webpages with an embedded video, a healthcare provider pamphlet and an ACC exhibit booth panel made unsupported claims about urination, bladder benefits, hypokalemia, natriuresis and superiority over other loop diuretics. They also minimized or left out risks, gave an incomplete indication and were not submitted on Form FDA-2253.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sarfez-pharmaceuticals-inc-708901-04252025","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":2956,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"sarfez-soaanz-2025-04-25"},{"id":"u185959","type":"untitled","date":"2025-03-21","company":"Taiho Oncology","listedAs":"Taiho Oncology, Inc.","brand":"LYTGOBI","generic":"futibatinib","product":"NDA 214801, LYTGOBI (futibatinib) tablets, for oral use","appType":"NDA","appNumber":"214801","matter":"89","audience":"professional","channels":["website"],"piece":"'Efficacy Results' webpage on LYTGOBI HCP branded website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The webpage makes false or misleading representations about the benefits of Lytgobi."},"summary":"An Efficacy Results webpage on the Lytgobi healthcare provider website showed progression-free survival, overall survival and disease control rate results from a single-arm trial. FDA said that study design could not support these efficacy representations, and the disclaimers did not correct them.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/185959/download?attachment","promo":[{"url":"https://www.fda.gov/media/185960/download?attachment","format":"PDF"}],"closeoutDate":"2025-05-21","closeoutUrl":"https://www.fda.gov/media/186728/download?attachment","closeoutKnown":true,"closeoutDays":61,"words":2192,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"taiho-oncology-lytgobi-2025-03-21"},{"id":"u185653","type":"untitled","date":"2025-02-03","company":"Edenbridge Pharmaceuticals","listedAs":"Edenbridge DBA Dexcel","brand":"HEMADY","generic":"dexamethasone","product":"NDA 211379, HEMADY (dexamethasone tablets), for oral use","appType":"NDA","appNumber":"211379","matter":"33","audience":"professional","channels":["exhibit"],"piece":"Exhibit booth panel 'Hemady Conference Banner'","categories":["risk_omission","efficacy_claims","superiority","dosing_convenience"],"quotes":{"risk_omission":"The exhibit panel is misleading because it presents efficacy claims for Hemady but fails to communicate any risk information.","efficacy_claims":"the referenced study does not support conclusions regarding comparative adherence to Hemady and generic dexamethasone 4 mg in the treatment of patients with MM due to limitations associated with the study design and methodology.","superiority":"the results of the study do not establish improved patient adherence associated with Hemady relative to generic dexamethasone 4 mg.","dosing_convenience":"suggesting improved patient adherence to Hemady as compared with generic dexamethasone 4 mg tablets."},"summary":"An exhibit booth panel for Hemady presented efficacy claims with no risk information. FDA also said its real-world comparison table suggested better adherence than generic dexamethasone, but the cited study's design and methodology did not support that conclusion.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/media/185653/download?attachment","promo":[{"url":"https://www.fda.gov/media/185654/download?attachment","format":"PDF"}],"closeoutDate":"2025-03-21","closeoutUrl":"https://www.fda.gov/media/185994/download?attachment","closeoutKnown":true,"closeoutDays":46,"words":1756,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"edenbridge-pharmaceuticals-hemady-2025-02-03"},{"id":"u183512","type":"untitled","date":"2024-10-31","company":"Merz Pharmaceuticals","listedAs":"Merz Pharmaceuticals GmbH","brand":"Xeomin","generic":"incobotulinumtoxina","product":"BLA 125360 XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use","appType":"BLA","appNumber":"125360","matter":"883","audience":"consumer","channels":["social_media","spokesperson"],"piece":"Instagram reel 'Xeomin Aesthetic Social Media' with Nate Berkus","categories":["risk_presentation","superiority","dosing_convenience"],"quotes":{"risk_presentation":"The overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Xeomin.","dosing_convenience":"This presentation misleadingly suggests that Xeomin provides faster or more rapid results than have been demonstrated.","superiority":"These claims misleadingly suggest that due to its manufacturing process and formulation, Xeomin offers benefits over other botulinum toxin products, when this has not been demonstrated."},"summary":"An Instagram reel by Merz and paid partner Nate Berkus promoted Xeomin. FDA said it put the risk information in fast, small scrolling text after the reel seemed to end, implied results in time for a same-day event, and implied an unproven advantage over other botulinum toxins.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/183512/download?attachment","promo":[{"url":"https://www.fda.gov/media/183513/download?attachment","format":""}],"closeoutDate":"2025-04-07","closeoutUrl":"https://www.fda.gov/media/186666/download?attachment","closeoutKnown":true,"closeoutDays":158,"words":1810,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"merz-pharmaceuticals-xeomin-2024-10-31"},{"id":"u181754","type":"untitled","date":"2024-08-29","company":"AbbVie","listedAs":"AbbVie, Inc.","brand":"UBRELVY","generic":"ubrogepant","product":"NDA 211765, UBRELVY (ubrogepant) tablets, for oral use","appType":"NDA","appNumber":"211765","matter":"934","audience":"consumer","channels":["tv_ad","spokesperson"],"piece":"30-second TV ad 'Serena TV :30' featuring Serena Williams","categories":["efficacy_claims","dosing_convenience"],"quotes":{"efficacy_claims":"These claims and presentations misleadingly suggest that Ubrelvy provides greater benefits to patients with acute migraine headache than has been demonstrated.","dosing_convenience":"misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials."},"summary":"A direct-to-consumer TV ad featuring Serena Williams claimed one dose of Ubrelvy works fast to eliminate migraine pain. FDA said it overstated the benefit and speed of relief, since only about 19% to 22% of trial patients were pain free at two hours.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/181754/download?attachment","promo":[{"url":"https://www.fda.gov/media/181755/download?attachment","format":"PDF"}],"closeoutDate":"2024-10-30","closeoutUrl":"https://www.fda.gov/media/183357/download?attachment","closeoutKnown":true,"closeoutDays":62,"words":1850,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"abbvie-ubrelvy-2024-08-29"},{"id":"u180633","type":"untitled","date":"2024-08-01","company":"Bristol Myers Squibb","listedAs":"Mirati Therapeutics Inc., a Bristol Myers Squibb Co.","brand":"KRAZATI","generic":"adagrasib","product":"NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use","appType":"NDA","appNumber":"216340","matter":"166","audience":"professional","channels":["website"],"piece":"'KRYSTAL-1 Efficacy' webpage on healthcare provider branded website","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The median DOR reported from this graph, “12.5 MONTHS,” misleadingly overstates the efficacy of Krazati."},"summary":"A KRYSTAL-1 efficacy webpage on the Krazati healthcare provider website presented disease control rate, overall and progression-free survival, pooled duration of response and intracranial response claims. FDA said these claims are not supported by the single-arm trial data and overstate efficacy.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/media/180633/download?attachment","promo":[{"url":"https://www.fda.gov/media/180634/download?attachment","format":"PDF"}],"closeoutDate":"2024-12-11","closeoutUrl":"https://www.fda.gov/media/184455/download?attachment","closeoutKnown":true,"closeoutDays":132,"words":2953,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"bristol-myers-squibb-krazati-2024-08-01"},{"id":"u180350","type":"untitled","date":"2024-07-17","company":"kaleo","listedAs":"Kaleo, Inc.","brand":"AUVI-Q","generic":"epinephrine injection","product":"NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use","appType":"NDA","appNumber":"201739","matter":"1021","audience":"consumer","channels":["social_media","spokesperson","online_video"],"piece":"Paid influencer Instagram reel post by Brittany Mahomes","categories":["risk_omission"],"quotes":{"risk_omission":"The post is misleading because it presents efficacy claims for Auvi-Q but fails to communicate any risk information."},"summary":"A paid influencer Instagram post by Brittany Mahomes for Auvi-Q made efficacy claims but left out all risk information. FDA said this creates a misleading impression of the drug's safety.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/180350/download?attachment","promo":[{"url":"https://www.fda.gov/media/180349/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/180362/download?attachment","format":""}],"closeoutDate":"2024-09-27","closeoutUrl":"https://www.fda.gov/media/182364/download?attachment","closeoutKnown":true,"closeoutDays":72,"words":1219,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"kaleo-auvi-q-2024-07-17"},{"id":"u175584","type":"untitled","date":"2024-01-18","company":"Novartis","listedAs":"Novartis Pharmaceuticals Corporation","brand":"Kisqali","generic":"ribociclib","product":"NDA 209092 KISQALI (ribociclib) tablets, for oral use","appType":"NDA","appNumber":"209092","matter":"1344","audience":"consumer","channels":["tv_ad"],"piece":"TV ad 'KISQALI_MBC_Long Live-Post Meno_US_11.22'","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The TV ad makes false or misleading representations about the efficacy of Kisqali."},"summary":"A direct-to-consumer TV ad for Kisqali claimed it preserves quality of life and helps women live longer. FDA said the quality-of-life claims lacked support from exploratory data, and the survival qualifying text was too fast and drowned out by competing visuals and audio.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/175584/download?attachment","promo":[{"url":"https://www.fda.gov/media/175585/download?attachment","format":"PDF"}],"closeoutDate":"2024-03-15","closeoutUrl":"https://www.fda.gov/media/180499/download?attachment","closeoutKnown":true,"closeoutDays":57,"words":2443,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"novartis-kisqali-2024-01-18"},{"id":"u173730","type":"untitled","date":"2023-10-31","company":"Otsuka Pharmaceutical Development and Commercialization","listedAs":"Otsuka Pharmaceutical Development and Commercialization, Inc","brand":"Rexulti","generic":"brexpiprazole","product":"NDA 205422 REXULTI (brexpiprazole) tablets, for oral use","appType":"NDA","appNumber":"205422","matter":"772","audience":"consumer","channels":["tv_ad","website"],"piece":"TV ad 'See the Signs' and desktop display banners","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"The TV ad and banner make false or misleading claims and representations about the efficacy of Rexulti."},"summary":"A consumer TV ad and desktop display banners for Rexulti claimed that adding it to an antidepressant cut depression symptoms 62% more. FDA said study data showed a reduction of only about 5% to 12%, so the claim overstated efficacy.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/173730/download?attachment","promo":[{"url":"https://www.fda.gov/media/173731/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/173732/download?attachment","format":"PDF"}],"closeoutDate":"2023-12-20","closeoutUrl":"https://www.fda.gov/media/175161/download?attachment","closeoutKnown":true,"closeoutDays":50,"words":1610,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"otsuka-pharmaceutical-development-and-commercialization-rexulti-2023-10-31"},{"id":"u173696","type":"untitled","date":"2023-10-31","company":"Evofem Biosciences","listedAs":"Evofem Biosciences","brand":"Phexxi","generic":"","product":"NDA 208352 PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gel","appType":"NDA","appNumber":"208352","matter":"176","audience":"consumer","channels":["brochure"],"piece":"Phexxi brochure with per-act-of-sex efficacy claims","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These claims create a misleading impression by overstating the efficacy of Phexxi."},"summary":"A Phexxi brochure claimed the product prevented pregnancy 99% of the time, based on a per-act-of-sex analysis. FDA said this method is not validated and overstates efficacy compared with the pregnancy rates in the prescribing information.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/173696/download?attachment","promo":[{"url":"https://www.fda.gov/media/173695/download?attachment","format":"PDF"}],"closeoutDate":"2024-01-05","closeoutUrl":"https://www.fda.gov/media/175295/download?attachment","closeoutKnown":true,"closeoutDays":66,"words":1032,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"evofem-biosciences-phexxi-2023-10-31"},{"id":"u171460","type":"untitled","date":"2023-08-11","company":"Exeltis","listedAs":"Exeltis USA Inc.","brand":"SLYND","generic":"drospirenone","product":"NDA 211367 SLYND (drospirenone) tablets, oral","appType":"NDA","appNumber":"211367","matter":"40","audience":"professional","channels":["social_media"],"piece":"Facebook sponsored post 'Slynd (drospirenone)'","categories":["risk_omission","efficacy_claims","form_2253"],"quotes":{"risk_omission":"is misleading because it presents claims and representations about the benefits of Slynd but fails to communicate any risk information","efficacy_claims":"This claim is misleading because it overstates the efficacy of Slynd by claiming patients will have a “period,” or bleeding, that is predictable and “on a schedule” when this has not been demonstrated.","form_2253":"A copy of the post was not submitted to OPDP under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A Facebook sponsored post for Slynd made benefit claims but included no risk information. FDA also said it overstated efficacy by claiming periods on a schedule, and that the post was not submitted on Form FDA-2253 at first publication.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/171460/download?attachment","promo":[{"url":"https://www.fda.gov/media/171459/download?attachment","format":"PDF"}],"closeoutDate":"2023-10-20","closeoutUrl":"https://www.fda.gov/media/173365/download?attachment","closeoutKnown":true,"closeoutDays":70,"words":1491,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"exeltis-slynd-2023-08-11"},{"id":"wastrazeneca-pharmaceuticals-lp-664789-08042023","type":"warning","date":"2023-08-04","company":"AstraZeneca","listedAs":"","brand":"BREZTRI AEROSPHERE","generic":"budesonide, glycopyrrolate, and formoterol fumarate","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["sales_aid"],"piece":"Professional sales aid (US-68433)","categories":["efficacy_claims"],"quotes":{"efficacy_claims":"These claims and presentation are concerning from a public health perspective because they overstate the efficacy of the drug and misleadingly suggest that Breztri will have a positive impact on ACM"},"summary":"A professional sales aid for Breztri presented an all-cause mortality benefit from secondary, non-significant trial data. It also presented a severe exacerbation reduction versus ICS/LABA with a p-value implying statistical significance. FDA said both claims overstate the drug's efficacy.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-08042023","promo":[],"closeoutDate":"2024-05-29","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-05292024","closeoutKnown":true,"closeoutDays":299,"words":1954,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"astrazeneca-breztri-aerosphere-2023-08-04"},{"id":"u169419","type":"untitled","date":"2023-06-07","company":"Xeris Pharmaceuticals","listedAs":"Xeris Pharmaceuticals, Inc.","brand":"Recorlev","generic":"levoketoconazole","product":"NDA 214133 RECORLEV (levoketoconazole) tablets, oral","appType":"NDA","appNumber":"214133","matter":"14","audience":"consumer","channels":["website"],"piece":"Consumer website webpages 'What is Recorlev?' and 'Taking Recorlev'","categories":["risk_omission","risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"misleadingly overstates the efficacy of Recorlev","risk_omission":"This presentation minimizes the serious and significant risks associated with the use of Recorlev by acknowledging that","risk_presentation":"the boxed warnings are relegated to the middle of this consolidated risk section, after the contraindications and indication and use statement, and without any significant signal to alert the viewer to them"},"summary":"Two pages of the Recorlev consumer website overstated efficacy using SONICS and LOGICS study results and left out material study limitations. They also minimized serious risks, including the boxed warnings for hepatotoxicity and QT prolongation, and suggested that monitoring would avoid side effects.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/169419/download?attachment","promo":[{"url":"https://www.fda.gov/media/169418/download?attachment","format":"PDF"}],"closeoutDate":"2023-08-09","closeoutUrl":"https://www.fda.gov/media/170996/download?attachment","closeoutKnown":true,"closeoutDays":63,"words":2272,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"xeris-pharmaceuticals-recorlev-2023-06-07"},{"id":"u158997","type":"untitled","date":"2022-06-02","company":"Althera Pharmaceuticals","listedAs":"Althera Pharmaceuticals","brand":"Roszet","generic":"rosuvastatin and ezetimibe","product":"NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral use","appType":"NDA","appNumber":"213072","matter":"4","audience":"professional","channels":["other"],"piece":"Roszet promotional communication with LDL-C reduction claims","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"These claims and presentations create a misleading impression regarding the efficacy of Roszet in achieving specific levels of LDL-C reduction over specific periods of time.","risk_presentation":"fails to present information relating to the contraindications and warnings and precautions for Roszet with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Roszet."},"summary":"A Roszet promotional piece made LDL-C reduction claims based on combined unrelated studies and limited trials, and omitted the diet context of the indication. Its serious risk information was far less prominent than its benefit claims.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/158997/download?attachment","promo":[{"url":"https://www.fda.gov/media/158998/download?attachment","format":"PDF"}],"closeoutDate":"2022-06-15","closeoutUrl":"https://www.fda.gov/media/160679/download?attachment","closeoutKnown":true,"closeoutDays":13,"words":2478,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"althera-pharmaceuticals-roszet-2022-06-02"},{"id":"u159926","type":"untitled","date":"2022-03-31","company":"Bausch Health","listedAs":"Bausch Health Companies Inc","brand":"DUOBRII","generic":"halobetasol propionate and tazarotene","product":"NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical use","appType":"NDA","appNumber":"209354","matter":"178","audience":"both","channels":["online_video","spokesperson","website"],"piece":"Direct-to-consumer video and healthcare professional efficacy webpage","categories":["risk_omission","risk_presentation","efficacy_claims","superiority"],"quotes":{"risk_omission":"Moreover, the video fails to include any information regarding the warning and precaution for","risk_presentation":"The overall effect of disclosing risk information in this manner undermines the","efficacy_claims":"The webpage creates a misleading impression regarding the efficacy and mechanism of","superiority":"Together, these claims are misleading because they suggest that Duobrii is clinically superior"},"summary":"A consumer video featuring physician and patient spokespersons, and an efficacy page on the healthcare professional website. FDA said the video left out serious risks and buried risk information, and that both pieces made unsupported first-and-only, superiority, synergy and efficacy claims.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/159926/download?attachment","promo":[{"url":"https://www.fda.gov/media/157589/download?attachment","format":"PDF"},{"url":"https://www.fda.gov/media/157590/download?attachment","format":"PDF"}],"closeoutDate":"2022-06-02","closeoutUrl":"https://www.fda.gov/media/159196/download?attachment","closeoutKnown":true,"closeoutDays":63,"words":2407,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"bausch-health-duobrii-2022-03-31"},{"id":"wcytodyn-inc-626957-02112022","type":"warning","date":"2022-02-11","company":"CytoDyn","listedAs":"","brand":"leronlimab","generic":"leronlimab","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["online_video","spokesperson","website"],"piece":"Proactive Media video interview featuring Dr. Nader Pourhassan","categories":["efficacy_claims","broader_use"],"quotes":{"broader_use":"The video represents in a promotional context that leronlimab, an investigational new drug, is safe and effective for the purpose for which it is being investigated or otherwise promotes the drug.","efficacy_claims":"the video is extremely concerning because it significantly mischaracterizes the clinical trial data for leronlimab in the treatment of COVID-19"},"summary":"A Proactive Media video interview with CytoDyn's chief executive, linked from the company website, promoted investigational leronlimab for COVID-19. FDA said it presented the drug as safe and effective and mischaracterized clinical trial data.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-02112022","promo":[],"closeoutDate":"2023-04-27","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-04272023","closeoutKnown":true,"closeoutDays":440,"words":2076,"citesStatute":false,"asks15Days":true,"warnsEnforcement":false,"slug":"cytodyn-leronlimab-2022-02-11"},{"id":"u155627","type":"untitled","date":"2022-01-19","company":"Eli Lilly","listedAs":"Eli Lilly & Company","brand":"TRULICITY","generic":"dulaglutide","product":"BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous use","appType":"BLA","appNumber":"125469","matter":"1035","audience":"consumer","channels":["social_media"],"piece":"Instagram post 'Trulicity 2020 Instagram Ad – 10,080 Minutes'","categories":["risk_omission","risk_presentation","efficacy_claims","broader_use"],"quotes":{"broader_use":"By failing to adequately communicate the indication and limitations of use associated with Trulicity, the post creates a misleading impression about the scope of the FDA-approved indication.","efficacy_claims":"the suggestion that Trulicity will help “lower A1C” in all patients, when this has not been demonstrated.","risk_presentation":"the risk information is in a small window relegated to the bottom of the post and is presented using fast-paced, scrolling, small font that is difficult to read","risk_omission":"By omitting this material information about this risk, the post creates a misleading impression about the drug’s safety."},"summary":"An Instagram video post for Trulicity said the drug lowers A1C but did not properly convey the indication or its limits. FDA said it showed risk information in small, fast-scrolling text and left out the hypoglycemia risk when used with insulin secretagogues or insulin.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/media/155627/download?attachment","promo":[{"url":"https://www.fda.gov/media/155628/download?attachment","format":"PDF"}],"closeoutDate":"2022-02-22","closeoutUrl":"https://www.fda.gov/media/156514/download?attachment","closeoutKnown":true,"closeoutDays":34,"words":1491,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"eli-lilly-trulicity-2022-01-19"},{"id":"u155419","type":"untitled","date":"2021-12-13","company":"Eli Lilly","listedAs":"Emgality","brand":"EMGALITY","generic":"galcanezumab-gnlm","product":"BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use","appType":"BLA","appNumber":"761063","matter":"558","audience":"consumer","channels":["tv_ad","spokesperson"],"piece":"TV ads 'The Journey Forward: Ryan Murphy' and 'Allysa Seely'","categories":["risk_omission","missing_disclosure","form_2253"],"quotes":{"risk_omission":"By omitting the major side effects and contraindications associated with Emgality, the TV ads fail to provide material information about the consequences that may result from the use of the drug","missing_disclosure":"The TV ads also fail to either provide adequate provision or a brief summary as required by 21 CFR 202.1(e)(1).","form_2253":"A copy of each TV ad was not submitted to OPDP under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i)."},"summary":"Two direct-to-consumer TV ads featuring Team USA athletes suggested Emgality's use for migraine but gave no risk information, no brief summary or adequate provision, an incomplete indication, and were not submitted to FDA at first publication.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/155419/download?attachment","promo":[],"closeoutDate":"2022-01-12","closeoutUrl":"https://www.fda.gov/media/155420/download?attachment","closeoutKnown":true,"closeoutDays":30,"words":1513,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"eli-lilly-emgality-2021-12-13"},{"id":"u151527","type":"untitled","date":"2021-08-09","company":"Eton Pharmaceuticals","listedAs":"Alkindi Sprinkle","brand":"ALKINDI SPRINKLE","generic":"hydrocortisone","product":"NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules","appType":"NDA","appNumber":"213876","matter":"13","audience":"consumer","channels":["search_ad"],"piece":"Google sponsored links","categories":["risk_omission"],"quotes":{"risk_omission":"These sponsored links are false or misleading in that they present information about the benefits of Alkindi Sprinkle, but fail to include any risk information about the drug."},"summary":"Google sponsored links for Alkindi Sprinkle presented benefit and dosing claims for children with adrenal insufficiency. FDA objected that they included no risk information, creating a misleading impression of the drug's safety.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/151527/download?attachment","promo":[{"url":"https://www.fda.gov/media/151528/download?attachment","format":"PDF"}],"closeoutDate":"2021-10-04","closeoutUrl":"https://www.fda.gov/media/155609/download?attachment","closeoutKnown":true,"closeoutDays":56,"words":1061,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"eton-pharmaceuticals-alkindi-sprinkle-2021-08-09"},{"id":"u150751","type":"untitled","date":"2021-07-07","company":"Amgen","listedAs":"Amgen","brand":"Neulasta","generic":"pegfilgrastim","product":"BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use","appType":"BLA","appNumber":"125031","matter":"1706","audience":"professional","channels":["other"],"piece":"Professional animated banner for Neulasta Onpro","categories":["efficacy_claims","superiority"],"quotes":{"efficacy_claims":"These claims and presentations create a misleading impression regarding the benefit of the product by stating that there is a statistically significant higher risk of febrile neutropenia","superiority":"could cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector (OBI) is more effective than Neulasta delivered via prefilled syringe (PFS)"},"summary":"A professional animated banner for Neulasta cited a real-world study to claim a higher febrile neutropenia risk with the prefilled syringe than with the Onpro on-body injector. FDA said the study's design limitations do not support the comparative claims.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/150751/download?attachment","promo":[{"url":"https://www.fda.gov/media/150752/download?attachment","format":"PDF"}],"closeoutDate":"2022-01-11","closeoutUrl":"https://www.fda.gov/media/155610/download?attachment","closeoutKnown":true,"closeoutDays":188,"words":1930,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"amgen-neulasta-2021-07-07"},{"id":"u146528","type":"untitled","date":"2021-03-08","company":"Biohaven Pharmaceuticals","listedAs":"Biohaven Pharmaceuticals","brand":"Nurtec ODT","generic":"rimegepant","product":"NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use","appType":"NDA","appNumber":"212728","matter":"71","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Spokesperson video interview with Khloé Kardashian on The View","categories":["risk_presentation","efficacy_claims","superiority","dosing_convenience","missing_disclosure","form_2253"],"quotes":{"efficacy_claims":"There were no pre-specified endpoints that evaluated the efficacy of the drug at 15 or 30 minutes after dosing.","dosing_convenience":"These claims misleadingly suggest that patients treated with Nurtec ODT will experience “relief” within 15 to 30 minutes of taking the drug.","superiority":"These comparative claims are misleading because they suggest that Nurtec ODT is clinically superior to or more effective than other prescription and over-the-counter (OTC) products, when this has not been demonstrated.","missing_disclosure":"it fails to adequately communicate Nurtec ODT’s full FDA-approved indication and limitations of use.","risk_presentation":"the video contains claims and/or representations about the benefits of Nurtec ODT in the audio portion, while the risk information is presented in text only format and in small font.","form_2253":"A copy of the video was not submitted to OPDP under cover of Form FDA-2253 at the time of initial dissemination as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A direct-to-consumer video interview with paid spokesperson Khloé Kardashian on The View. FDA said it made unsupported claims about how fast the drug relieves migraine, implied it beats other treatments, did not convey the full indication, buried the risk information, and was not submitted on Form FDA-2253.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/media/146528/download?attachment","promo":[],"closeoutDate":"2021-11-19","closeoutUrl":"https://www.fda.gov/media/155611/download?attachment","closeoutKnown":true,"closeoutDays":256,"words":1975,"citesStatute":true,"asks15Days":true,"warnsEnforcement":false,"slug":"biohaven-pharmaceuticals-nurtec-odt-2021-03-08"},{"id":"wcoopersurgical-inc-613339-02122021","type":"warning","date":"2021-02-12","company":"CooperSurgical","listedAs":"","brand":"Paragard","generic":"intrauterine copper contraceptive","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["online_video","spokesperson"],"piece":"Sponsored video 'Paragard: Family Planning During The Pandemic'","categories":["risk_omission","form_2253"],"quotes":{"risk_omission":"The video is false or misleading in that it presents efficacy claims for Paragard, but fails to communicate any risk information associated with its use.","form_2253":"A copy of the video was not submitted to OPDP under cover of Form FDA-2253 at the time of initial dissemination as required by 21 CFR 314.81(b)(3)(i)."},"summary":"A sponsored direct-to-consumer video segment featured a physician interview promoting Paragard as a non-hormonal family planning option. FDA objected that it made efficacy claims without any risk information and was not submitted at first dissemination.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/coopersurgical-inc-613339-02122021","promo":[],"closeoutDate":"2022-01-19","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/coopersurgical-inc-613339-01192022","closeoutKnown":true,"closeoutDays":341,"words":1444,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"coopersurgical-paragard-2021-02-12"},{"id":"wacelrx-pharmaceuticals-inc-613257-02112021","type":"warning","date":"2021-02-11","company":"AcelRx Pharmaceuticals","listedAs":"","brand":"DSUVIA","generic":"sufentanil","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["website","exhibit"],"piece":"'SDS Banner Ad' banner and tabletop display","categories":["risk_omission","risk_presentation","dosing_convenience"],"quotes":{"dosing_convenience":"These presentations are misleading because they imply that the administration of Dsuvia consists of a simple, one-step process, when this is not the case.","risk_omission":"By omitting this material information about the maximum daily dosage, the banner creates a misleading impression about the safe use of Dsuvia.","risk_presentation":"the banner and display fail to present information relating to the Boxed Warning, Contraindications, Warnings and Precautions, and Adverse Reactions for Dsuvia with a prominence and readability reasonably comparable"},"summary":"A banner ad and tabletop display for Dsuvia implied administration was a simple one-step process, omitted the maximum daily dose, inadequately conveyed limitations of use, and presented risk information with less prominence than benefit claims.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acelrx-pharmaceuticals-inc-613257-02112021","promo":[],"closeoutDate":"2022-03-28","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acelrx-pharmaceuticals-inc-613257-03282022","closeoutKnown":true,"closeoutDays":410,"words":1969,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"acelrx-pharmaceuticals-dsuvia-2021-02-11"},{"id":"u144115","type":"untitled","date":"2020-11-24","company":"Azurity Pharmaceuticals","listedAs":"Azurity Pharmaceuticals Inc.","brand":"XATMEP","generic":"methotrexate","product":"NDA 208400 XATMEP® (methotrexate) oral solution","appType":"NDA","appNumber":"208400","matter":"50","audience":"professional","channels":["email"],"piece":"Healthcare professional email (XTM-27)","categories":["risk_omission","risk_presentation","broader_use"],"quotes":{"risk_omission":"By minimizing the Boxed Warning and omitting the other material information related to the serious risks associated with Xatmep, the email misleadingly suggests that Xatmep is safer than has been demonstrated.","risk_presentation":"the email fails to also present the limited risk information included in the email with a prominence and readability reasonably comparable to the presentation of information relating to the benefits of the drug.","broader_use":"it suggests the drug is approved for use in patients of all ages without consideration for the necessity of other treatments as part of a combination therapy"},"summary":"A healthcare professional email for Xatmep put its Boxed Warning after the signature block, left out other risk information, and did not fully state the approved pediatric combination-therapy indication.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/144115/download?attachment","promo":[{"url":"https://www.fda.gov/media/144114/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1016,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"azurity-pharmaceuticals-xatmep-2020-11-24"},{"id":"wnephron-sc-inc-610867-09222020","type":"warning","date":"2020-09-22","company":"Nephron","listedAs":"","brand":"Budesonide Inhalation Suspension","generic":"budesonide","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["email"],"piece":"Two promotional emails, including one linking a YouTube physician video","categories":["risk_omission","broader_use"],"quotes":{"broader_use":"The emails provide evidence that Budesonide is intended for a new use for which it lacks approval, specifically treatment of symptoms associated with “Coronavirus Disease 2019” (COVID-19)","risk_omission":"the emails fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the safety of Budesonide."},"summary":"Emails from Nephron's executive and a sales representative promoted budesonide inhalation suspension for COVID-19 symptoms, a use it is not approved for. FDA also objected that the emails described benefits but gave no risk information.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nephron-sc-inc-610867-09222020","promo":[],"closeoutDate":"2021-02-19","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nephron-sterile-compounding-center-llc-610867-02192021","closeoutKnown":true,"closeoutDays":150,"words":1720,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"nephron-budesonide-inhalation-suspension-2020-09-22"},{"id":"wsprout-pharmaceuticals-inc-610569-08312020","type":"warning","date":"2020-08-31","company":"Sprout Pharmaceuticals","listedAs":"","brand":"Addyi","generic":"flibanserin","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["radio_ad"],"piece":"Direct-to-consumer radio ad (US—1900289.03)","categories":["risk_omission","broader_use"],"quotes":{"risk_omission":"However, it completely omits all the contraindications associated with the use of Addyi.","broader_use":"This is particularly concerning given the serious risks of this product and the suggestion that Addyi is approved for all women “frustrated by their low libido” when this is not the case."},"summary":"A direct-to-consumer radio ad for Addyi left out its contraindications and important Boxed Warning and other risk information. FDA also said it overstated the approved indication by omitting the limitations of use.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-610569-08312020","promo":[],"closeoutDate":"2021-03-15","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-610569-03152021","closeoutKnown":true,"closeoutDays":196,"words":1704,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"sprout-pharmaceuticals-addyi-2020-08-31"},{"id":"u141347","type":"untitled","date":"2020-08-14","company":"Xeris Pharmaceuticals","listedAs":"Xeris Pharmaceuticals, Inc.","brand":"Gvoke","generic":"glucagon","product":"NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use","appType":"NDA","appNumber":"212097","matter":"43","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'Gvoke PFS TV Commercial (:60)'","categories":["risk_omission","dosing_convenience"],"quotes":{"risk_omission":"the TV ad fails to include the contraindication in patients with a known hypersensitivity to glucagon or to any of the excipients in Gvoke","dosing_convenience":"These claims misleadingly suggest that the Gvoke pre-filled syringe can be easily used and individuals can confidently recognize that they have correctly administered the product."},"summary":"A direct-to-consumer TV ad for Gvoke left out hypersensitivity risks and the consequences of key contraindications. FDA also said it made unsupported ease-of-use claims, minimized the seriousness of severe hypoglycemia and omitted when and by whom the drug should be given.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/141347/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1696,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"xeris-pharmaceuticals-gvoke-2020-08-14"},{"id":"woutlook-pharmaceuticals-inc-605071-02212020","type":"warning","date":"2020-02-21","company":"Outlook Pharmaceuticals","listedAs":"","brand":"ProCentra","generic":"dextroamphetamine sulfate","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["search_ad"],"piece":"Google.com sponsored link for ProCentra","categories":["risk_omission","missing_disclosure"],"quotes":{"risk_omission":"This sponsored link is false or misleading in that it presents information about the benefits of ProCentra, but fails to include any risk information about the drug.","missing_disclosure":"The sponsored link fails to present the established name for ProCentra (dextroamphetamine sulfate), thereby misbranding the product."},"summary":"A Google sponsored search link for ProCentra oral solution presented benefit claims such as liquid form and bubblegum flavor but included no risk information, including the Boxed Warning, and omitted the required established name.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/outlook-pharmaceuticals-inc-605071-02212020","promo":[],"closeoutDate":"2021-11-17","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mikart-llc-605071-11172021","closeoutKnown":true,"closeoutDays":635,"words":1573,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"outlook-pharmaceuticals-procentra-2020-02-21"},{"id":"walkermes-inc-597260-12022019","type":"warning","date":"2019-12-02","company":"Alkermes","listedAs":"","brand":"VIVITROL","generic":"naltrexone for extended-release injectable suspension","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["print_ad"],"piece":"Print advertisement (VIV-003460-v2)","categories":["risk_omission"],"quotes":{"risk_omission":"By omitting this serious and potentially fatal risk, the print ad fails to provide material information about the consequences that may result from the use of the drug"},"summary":"A print ad for Vivitrol presented benefit claims but left out the risk of potentially fatal opioid overdose, along with other warnings such as injection site reactions and the most common adverse reactions.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alkermes-inc-597260-12022019","promo":[],"closeoutDate":"2020-09-09","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alkermes-inc-597260-09092020","closeoutKnown":true,"closeoutDays":282,"words":1648,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"alkermes-vivitrol-2019-12-02"},{"id":"u133021","type":"untitled","date":"2019-11-18","company":"Rockwell Medical","listedAs":"Rockwell Medical, Inc","brand":"Triferic","generic":"ferric pyrophosphate citrate","product":"NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration","appType":"NDA","appNumber":"206317","matter":"26","audience":"professional","channels":["website"],"piece":"Company webpage 'Triferic' under the Therapeutic Focus tab","categories":["risk_omission","superiority","broader_use","missing_disclosure"],"quotes":{"risk_omission":"The webpage contains claims and/or representations about the benefits of Triferic but fails to communicate any risk information about the product.","superiority":"These claims are misleading because they suggest Triferic is safer and more effective than other IV iron replacement products, when this has not been demonstrated.","missing_disclosure":"the webpage is misleading because it fails to provide material information regarding Triferic’s full FDA-approved indication, including important limitations of use.","broader_use":"This broad claim suggests that Triferic is indicated for patients receiving any type of dialysis, when it is not intended for use in patients receiving peritoneal dialysis"},"summary":"A company webpage for Triferic described its benefits without any risk information. FDA said it implied Triferic is safer and more effective than other IV iron products without evidence, and left out the full indication and limitations of use.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/133021/download?attachment","promo":[{"url":"https://www.fda.gov/media/133022/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1405,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"rockwell-medical-triferic-2019-11-18"},{"id":"u132641","type":"untitled","date":"2019-11-01","company":"Nascent Biotech","listedAs":"Nascent Biotech, Inc.","brand":"Pritumumab","generic":"pritumumab","product":"Pritumumab","appType":"","appNumber":"","matter":"1","audience":"consumer","channels":["website"],"piece":"Nascent Biotech company website Pritumumab product pages","categories":["risk_omission","efficacy_claims","broader_use"],"quotes":{"broader_use":"The website represents in a promotional context that Pritumumab, an investigational new drug, is safe and effective for the purpose for which it is being investigated or otherwise promotes the drug.","efficacy_claims":"These claims and presentations are extremely concerning given the lack of adequate safety and efficacy data for Pritumumab.","risk_omission":"The conclusions reflected in the above claims create a misleading impression regarding the safety and effectiveness of the product."},"summary":"Nascent's company website promoted investigational Pritumumab for brain cancer. FDA objected that it made conclusory claims of safety and efficacy, including a cure, before approval, and did not clearly disclose the drug's investigational status.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/132641/download?attachment","promo":[{"url":"https://www.fda.gov/media/132642/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1263,"citesStatute":false,"asks15Days":false,"warnsEnforcement":false,"slug":"nascent-biotech-pritumumab-2019-11-01"},{"id":"u131190","type":"untitled","date":"2019-09-24","company":"Kowa Pharmaceuticals","listedAs":"Kowa Pharmaceuticals, Inc.","brand":"LIVALO","generic":"pitavastatin","product":"NDA 022363 Livalo (pitavastatin) tablet, for oral use","appType":"NDA","appNumber":"022363","matter":"609","audience":"consumer","channels":["online_video"],"piece":"YouTube patient testimonial video montage (LIV-MT-3158)","categories":["risk_omission","risk_presentation","superiority"],"quotes":{"risk_omission":"it creates a misleading impression regarding the side effects a patient may experience as a result of Livalo treatment and deemphasizes the risks associated with taking the drug","superiority":"This presentation misleadingly suggests that Livalo is safer than its competitors by implying that patients switching to Livalo from other statins will experience a reduction in side effects compared to other statins","risk_presentation":"fails to present information relating to contraindications, warnings, precautions and adverse reactions for Livalo with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Livalo"},"summary":"A direct-to-consumer patient testimonial video on YouTube suggested that patients who switch to Livalo from other statins will have fewer or no side effects. FDA also objected that risk information appeared only as scrolling text at the bottom, competing with the testimonials.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/131190/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1638,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"kowa-pharmaceuticals-livalo-2019-09-24"},{"id":"wgalt-pharmaceuticals-llc-593156-09132019","type":"warning","date":"2019-09-13","company":"Galt Pharmaceuticals","listedAs":"","brand":"DORAL","generic":"quazepam","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["email"],"piece":"Professional email GLT-DOR-016","categories":["risk_omission","efficacy_claims","superiority","broader_use"],"quotes":{"risk_omission":"However, it completely omits the warning and precaution regarding benzodiazepine withdrawal syndrome.","superiority":"These claims and presentation are misleading because they minimize the risks of abuse and dependence associated with Doral and suggest that this C-IV scheduled drug is superior in safety to other prescription and over-the-counter (OTC) products.","efficacy_claims":"This claim is false because it suggests that Doral is the only marketed medication indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.","broader_use":"By omitting this information, the email creates a misleading impression about the use of Doral."},"summary":"A professional email for Doral omitted serious risk information, including benzodiazepine withdrawal and abuse potential, and claimed lower abuse potential than other sleep aids. It also falsely claimed Doral was the only medication for all three insomnia components and left out limits on its use.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/galt-pharmaceuticals-llc-593156-09132019","promo":[],"closeoutDate":"2020-06-03","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/galt-pharmaceuticals-llc-593156-06032020","closeoutKnown":true,"closeoutDays":264,"words":2251,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"galt-pharmaceuticals-doral-2019-09-13"},{"id":"wmetuchen-pharmaceuticals-llc-590713-08162019","type":"warning","date":"2019-08-16","company":"Metuchen Pharmaceuticals","listedAs":"","brand":"Stendra","generic":"avanafil","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["print_ad","website"],"piece":"Direct-to-consumer print ad and display banners","categories":["risk_omission","risk_presentation","efficacy_claims","superiority","broader_use","dosing_convenience","missing_disclosure"],"quotes":{"broader_use":"This claim provides evidence that Stendra is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use.","risk_omission":"they fail to include any of the contraindications or warnings and precautions of the drug, creating a misleading impression about the safety of Stendra.","risk_presentation":"the print ad fails to present the risk information with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of the drug","dosing_convenience":"This claim is misleading because it suggests that Stendra can safely be dosed to provide efficacy at any timepoint (i.e. “whenever you want”), when this is not the case.","efficacy_claims":"FDA is not aware of data to support Stendra’s efficacy outside of 15 minutes to 2 hours after dosing.","superiority":"This claim is misleading because it suggests that by being, “[T]he next-generation, PDE-5 inhibitor,” Stendra is safer or more effective than its competitors.","missing_disclosure":"The banners “06” are misleading because they fail to communicate material information regarding the indication for Stendra."},"summary":"FDA reviewed a consumer print ad and display banners for Stendra. It objected to a heart failure risk reduction claim, omitted risks, poorly presented risk information, unsupported claims about dosing whenever wanted and next-generation superiority, and banners that left out the indication.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/metuchen-pharmaceuticals-llc-590713-08162019","promo":[],"closeoutDate":"2020-09-18","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/metuchen-pharmaceuticals-llc-590713-09182020","closeoutKnown":true,"closeoutDays":399,"words":2728,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"metuchen-pharmaceuticals-stendra-2019-08-16"},{"id":"u129526","type":"untitled","date":"2019-07-25","company":"CooperSurgical","listedAs":"CooperSurgical, Inc.","brand":"ParaGard","generic":"intrauterine copper contraceptive","product":"NDA 018680 ParaGard T380A Intrauterine Copper Contraceptive","appType":"NDA","appNumber":"018680","matter":"578","audience":"consumer","channels":["tv_ad"],"piece":"30-second DTC TV ad 'Paragard 30 sec DTC Ad (Musical)'","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"By omitting serious risks associated with ParaGard and material facts pertaining to the risks of ParaGard, the TV ad misleadingly suggests that ParaGard is safer than has been demonstrated.","risk_presentation":"The TV ad is also misleading because it communicates important risk information in the visual portion of the TV ad only, i.e., as SUPERs."},"summary":"A 30-second direct-to-consumer TV ad for ParaGard left out important risks such as contraindications, pelvic inflammatory disease and expulsion. FDA also said distracting visuals, text-only risk statements and repeated hormone-free claims downplayed the device's risks.","badAd":true,"form2253":true,"letterUrl":"https://www.fda.gov/media/129526/download?attachment","promo":[{"url":"https://www.fda.gov/media/129525/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1749,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"coopersurgical-paragard-2019-07-25"},{"id":"u128151","type":"untitled","date":"2019-06-14","company":"Aclaris Therapeutics","listedAs":"Aclaris Therapeutics, Inc.","brand":"ESKATA","generic":"hydrogen peroxide","product":"NDA 209305 ESKATA (hydrogen peroxide) topical solution","appType":"NDA","appNumber":"209305","matter":"56","audience":"consumer","channels":["spokesperson","press_media","social_media","online_video"],"piece":"Paid physician spokesperson interview video broadcast on ABC's The View","categories":["risk_omission","risk_presentation","efficacy_claims"],"quotes":{"risk_omission":"By omitting the warnings and precautions associated with Eskata, the video fails to provide material information about the consequences that may result from the use of the drug","risk_presentation":"This large amount of unrelated information is presented at a fast pace over approximately 10 seconds and all competes for the consumer’s attention.","efficacy_claims":"These claims and presentations misleadingly represent that the typical patient treated with Eskata will experience similar results, i.e., complete clearance of all treated SK lesions."},"summary":"A direct-to-consumer video of a paid physician spokesperson interview, broadcast on The View and posted on Facebook and LinkedIn, left out serious eye and skin risks, played down common side effects and overstated how often lesions fully clear.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/128151/download?attachment","promo":[{"url":"https://www.fda.gov/media/128152/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":2331,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"aclaris-therapeutics-eskata-2019-06-14"},{"id":"u126604","type":"untitled","date":"2019-05-22","company":"VIVUS","listedAs":"VIVUS, Inc.","brand":"QSYMIA","generic":"phentermine and topiramate extended-release","product":"NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV","appType":"NDA","appNumber":"022580","matter":"414","audience":"consumer","channels":["website"],"piece":"Homepage of the Qsymia consumer website (qsymia.com)","categories":["risk_presentation","efficacy_claims"],"quotes":{"efficacy_claims":"These claims misleadingly suggest that Qsymia can help patients lose weight 3 times faster than diet and exercise alone.","risk_presentation":"The webpage fails to present information relating to contraindications, warnings, precautions, and adverse reactions for Qsymia with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Qsymia."},"summary":"The homepage of the Qsymia consumer website claimed 3 times faster weight loss without support. It presented selected weight-loss results without the diet and exercise context, placebo results, baseline or dropout context, and gave the risk information much less prominence than the benefits.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/126604/download?attachment","promo":[{"url":"https://www.fda.gov/media/126605/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":2011,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"vivus-qsymia-2019-05-22"},{"id":"u120674","type":"untitled","date":"2019-02-15","company":"Phoenix Molecular Imaging","listedAs":"Phoenix Molecular Imaging Center","brand":"11C-Acetate","generic":"11c-acetate","product":"Sodium Acetate (C-11)","appType":"","appNumber":"","matter":"1","audience":"consumer","channels":["website"],"piece":"Webpage describing 11C-Acetate PET imaging for recurrent prostate cancer","categories":["efficacy_claims","superiority","broader_use"],"quotes":{"broader_use":"The webpage contains claims and presentations that promote 11C-Acetate as safe and effective for the purpose for which it is being investigated or otherwise promote the drug","efficacy_claims":"an efficacy claim of clinical benefit that has not been established.","superiority":"suggest in a promotional context that 11C-Acetate, an investigational new drug, has been shown to be different from or superior to approved therapies for PET imaging"},"summary":"A webpage promoted 11C-Acetate, an investigational PET imaging agent, for detecting recurrent prostate cancer. FDA objected that it presented the unapproved drug as safe and effective, made unsupported efficacy claims, and suggested it was superior to approved imaging agents.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/120674/download?attachment","promo":[{"url":"https://www.fda.gov/media/120675/download?attachment","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1201,"citesStatute":false,"asks15Days":false,"warnsEnforcement":false,"slug":"phoenix-molecular-imaging-11c-acetate-2019-02-15"},{"id":"wvanda-pharmaceuticals-576442-10222018","type":"warning","date":"2018-10-22","company":"Vanda Pharmaceuticals","listedAs":"","brand":"Fanapt and Hetlioz","generic":"iloperidone and tasimelteon","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["website"],"piece":"Vanda corporate webpage titled 'Products'","categories":["risk_omission"],"quotes":{"risk_omission":"This webpage is false or misleading in that it presents information about the benefits of Fanapt and Hetlioz, but fails to include any risk information about either drug."},"summary":"A Vanda corporate webpage titled Products presented benefit claims for Fanapt and Hetlioz but included no risk information. FDA said this was misleading about the drugs' safety, given Fanapt's Boxed Warning.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vanda-pharmaceuticals-576442-10222018","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1359,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"vanda-pharmaceuticals-fanapt-and-hetlioz-2018-10-22"},{"id":"u117097","type":"untitled","date":"2018-10-11","company":"Eisai","listedAs":"Eisai Inc.","brand":"Fycompa","generic":"perampanel","product":"NDA 202834; 208277 Fycompa (perampanel) oral suspension, CIII Fycompa(perampanel) tablets, for oral use, CIII","appType":"NDA","appNumber":"202834","matter":"352","audience":"professional","channels":["spokesperson","speaker_program"],"piece":"Sales representative oral statements during presentation to healthcare professionals","categories":["risk_omission","broader_use"],"quotes":{"broader_use":"the Eisai sales representative made statements that provide evidence that Fycompa is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.","risk_omission":"The presentation minimizes the serious risks associated with Fycompa and misleadingly suggests the drug is safer than has been demonstrated."},"summary":"An Eisai sales representative made oral statements to healthcare professionals about Fycompa. FDA said the statements suggested unapproved new uses and minimized the serious risks in the Boxed Warning, including psychiatric and behavioral reactions.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/media/117097/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":912,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"eisai-fycompa-2018-10-11"},{"id":"wmannkind-corporation-578282-10052018","type":"warning","date":"2018-10-05","company":"MannKind","listedAs":"","brand":"AFREZZA","generic":"insulin human","product":"","appType":"","appNumber":"","matter":"","audience":"consumer","channels":["social_media"],"piece":"Facebook post on the Afrezza Facebook page","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"By suggesting that there are no risks associated with use of Afrezza, this post is misleading with respect to the drug’s safety.","risk_presentation":"However, presenting risk information for Afrezza in this manner does not mitigate the misleading impression from the claims in the post."},"summary":"A Facebook post for Afrezza suggested the drug carries no safety concerns. FDA said it omitted contraindications and warnings, and that a hover pop-up and a link to prescribing information did not correct the misleading impression of safety.","badAd":true,"form2253":false,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mannkind-corporation-578282-10052018","promo":[],"closeoutDate":"2019-10-23","closeoutUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mannkind-corporation-578282-10232019","closeoutKnown":true,"closeoutDays":383,"words":1480,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"mannkind-afrezza-2018-10-05"},{"id":"u114329","type":"untitled","date":"2018-08-16","company":"ASCEND Therapeutics","listedAs":"ASCEND Therapeutics US, LLC","brand":"EstroGel","generic":"estradiol","product":"NDA 021166 EstroGel 0.06% (estradiol gel) for topical use","appType":"NDA","appNumber":"021166","matter":"430","audience":"professional","channels":["sales_aid"],"piece":"Professional sell sheet 'EstroGel Sell Sheet-PS' (2017-EG-0022)","categories":["efficacy_claims","superiority"],"quotes":{"efficacy_claims":"This sell sheet makes false or misleading claims and/or representations about the efficacy of EstroGel.","superiority":"falsely suggests that EstroGel contains the lowest effective dose of estrogen compared to other estrogen products when, in fact, there are other FDA-approved products that are available at doses lower than EstroGel."},"summary":"A professional sell sheet for EstroGel claimed it provides the lowest effective dose of estrogen. FDA said the cited studies did not compare it with other estrogen products, and other approved products have lower doses.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/114329/download","promo":[{"url":"https://www.fda.gov/media/115891/download","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1376,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"ascend-therapeutics-estrogel-2018-08-16"},{"id":"u114446","type":"untitled","date":"2018-06-28","company":"Arog Pharmaceuticals","listedAs":"Arog Pharmaceuticals, Inc.","brand":"Crenolanib","generic":"crenolanib","product":"Crenolanib besylate","appType":"","appNumber":"","matter":"2","audience":"professional","channels":["exhibit","website"],"piece":"ASH exhibit booth display and Crenolanib webpage","categories":["efficacy_claims","superiority","broader_use"],"quotes":{"broader_use":"The booth display and webpage include claims and presentations that promote Crenolanib as safe and effective for the purposes for which it is being investigated or otherwise promote the drug","efficacy_claims":"states that Crenolanib is a “potent inhibitor for FLT3-ITD and secondary KD mutants,” an efficacy claim of clinical benefit that has not been established.","superiority":"these claims suggest in a promotional context that Crenolanib, an investigational new drug, has been shown to be different from or superior to other approved therapies for treating AML"},"summary":"An exhibit booth display at ASH and a webpage promoted the investigational drug Crenolanib for AML. FDA said they presented it as safe and effective, made unsupported efficacy claims, and suggested superiority over approved therapies.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/114446/download","promo":[{"url":"https://www.fda.gov/media/114454/download","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1321,"citesStatute":false,"asks15Days":false,"warnsEnforcement":false,"slug":"arog-pharmaceuticals-crenolanib-2018-06-28"},{"id":"u130321","type":"untitled","date":"2018-06-19","company":"Pfizer","listedAs":"Pfizer Inc.","brand":"ESTRING","generic":"estradiol vaginal ring","product":"NDA 020472 ESTRING® (estradiol vaginal ring)","appType":"NDA","appNumber":"020472","matter":"275","audience":"consumer","channels":["online_video","website","spokesperson"],"piece":"Spokesperson video interview on michiganmomliving.com","categories":["risk_omission","efficacy_claims","dosing_convenience"],"quotes":{"risk_omission":"However, the video fails to communicate any risk information about the product.","efficacy_claims":"FDA is not aware of data to support claims that Estring provides instant relief of moderate to severe symptoms of VVA due to menopause.","dosing_convenience":"This claim misleadingly suggests that patients will experience similar results, i.e., instant relief of their symptoms, after initiating treatment with Estring."},"summary":"A consumer video interview with paid Pfizer physician and patient spokespersons, posted on a website. FDA objected that it omitted all risk information despite a boxed warning, implied no side effects, and claimed instant symptom relief without supporting data.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/130321/download?attachment","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1584,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"pfizer-estring-2018-06-19"},{"id":"u111101","type":"untitled","date":"2018-02-09","company":"Collegium Pharmaceutical","listedAs":"Collegium Pharmaceuticals, Inc.","brand":"XTAMPZA ER","generic":"oxycodone","product":"NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use","appType":"NDA","appNumber":"208090","matter":"114","audience":"professional","channels":["exhibit"],"piece":"Exhibit booth PP-XT-US-0275 at ASHP Summer Meetings 2017","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"provide material information about the drug’s limitations of use and the serious and life-threatening consequences that may result from the use of the drug, thereby creating a misleading impression about the drug’s safety.","risk_presentation":"the side panel utilized a much smaller font size and plain white background, without any visual elements linking it to the principal display panel."},"summary":"An exhibit booth at a 2017 pharmacist meeting promoted Xtampza ER's abuse-deterrent properties. FDA said the main panel omitted the indication, limitations of use and boxed warning risks, and that risk and abuse-deterrence limitation information was placed where viewers could not easily see it.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/media/111101/download","promo":[{"url":"https://www.fda.gov/media/111117/download","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1790,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"collegium-pharmaceutical-xtampza-er-2018-02-09"},{"id":"u110684","type":"untitled","date":"2017-12-28","company":"UCLA","listedAs":"University of California Los Angeles (UCLA)","brand":"Ga68-PSMA","generic":"ga68-psma","product":"Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure)","appType":"","appNumber":"","matter":"1","audience":"consumer","channels":["website","brochure"],"piece":"UCLA webpage and brochure on PSMA-PET imaging","categories":["broader_use"],"quotes":{"broader_use":"these claims and presentations suggest in a promotional context that Ga68-PSMA , an investigational new drug, is safe or effective for"},"summary":"A UCLA webpage and brochure presented the investigational PET imaging agent Ga68-PSMA as safe and effective for detecting prostate cancer cells. FDA objected that this was promotion of an investigational drug that FDA has not approved for any use.","badAd":false,"form2253":false,"letterUrl":"https://www.fda.gov/media/110684/download","promo":[{"url":"https://www.fda.gov/media/110693/download","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1017,"citesStatute":false,"asks15Days":false,"warnsEnforcement":false,"slug":"ucla-ga68-psma-2017-12-28"},{"id":"wcipher-pharmaceuticals-us-llc-460380-08242017","type":"warning","date":"2017-08-24","company":"Cipher Pharmaceuticals","listedAs":"","brand":"ConZip","generic":"tramadol hydrochloride","product":"","appType":"","appNumber":"","matter":"","audience":"professional","channels":["sales_aid"],"piece":"Professional detail aid (CNZSA03201402)","categories":["risk_omission","missing_disclosure"],"quotes":{"risk_omission":"However, the detail aid fails to communicate any risk information about the product.","missing_disclosure":"the detail aid is misleading because it fails to provide material information regarding ConZip’s full FDA-approved indication, including important limitations of use."},"summary":"A professional detail aid for ConZip extended-release capsules made efficacy claims but included no risk information. FDA also said it left out the full approved indication and its important limitations of use.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipher-pharmaceuticals-us-llc-460380-08242017","promo":[],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1407,"citesStatute":true,"asks15Days":false,"warnsEnforcement":true,"slug":"cipher-pharmaceuticals-conzip-2017-08-24"},{"id":"uics-inc-contrave-untitled-letter-5182017","type":"untitled","date":"2017-05-18","company":"Orexigen Therapeutics","listedAs":"Orexigen Therapeutics, Inc.","brand":"CONTRAVE","generic":"naltrexone hcl and bupropion hcl","product":"NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets","appType":"NDA","appNumber":"200063","matter":"301","audience":"consumer","channels":["tv_ad"],"piece":"60-second TV ad 'BRAIN BOR WOMAN'S DAY: 60'","categories":["risk_omission","risk_presentation"],"quotes":{"risk_omission":"By omitting serious risks associated with Contrave, the TV ad misleadingly suggests that Contrave is safer than has been demonstrated.","risk_presentation":"The TV ad is also misleading because it communicates important risk information in the visual portion of the TV ad only, i.e., as SUPERs, and presents unrelated risk information in competing audio messages."},"summary":"A 60-second direct-to-consumer TV ad for Contrave left out contraindications and boxed warning information on neuropsychiatric reactions. It also showed key risk information only in on-screen text, while unrelated audio played over it.","badAd":false,"form2253":true,"letterUrl":"https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/orexigen-therapeutics-inc-contrave-untitled-letter-5182017","promo":[{"url":"https://www.fda.gov/media/105564/download","format":"PDF"}],"closeoutDate":"","closeoutUrl":"","closeoutKnown":false,"closeoutDays":null,"words":1559,"citesStatute":true,"asks15Days":false,"warnsEnforcement":false,"slug":"orexigen-therapeutics-contrave-2017-05-18"}]}