FDA OPDP Untitled Letters

Data through 26 October 2026.

OPDP untitled letters

120

Promotion warning letters

25

Untitled letters with a close-out

86

Snapshot rebuilt

11 November 2026

Latest letters

Vanda Pharmaceuticals: Nereus (tradipitant) Untitled letter · Omits or minimizes risk, Risk not clear and conspicuous, Broader use than approved

26 October 2026

Evolus: JEUVEAU (prabotulinumtoxina-xvfs) Untitled letter · Omits or minimizes risk, Risk not clear and conspicuous, Overstated or unsupported efficacy

28 September 2026

Alar Pharmaceuticals: ALA-3000 (ketamine pamoate) Untitled letter · Omits or minimizes risk, Overstated or unsupported efficacy, Unsupported superiority or comparison

21 August 2026

Amgen: Vectibix (panitumumab) Warning letter · Omits or minimizes risk, Broader use than approved, Missing required disclosure

12 August 2026

Travere Therapeutics: FILSPARI (sparsentan) Untitled letter · Omits or minimizes risk, Overstated or unsupported efficacy

28 July 2026

Sanofi: BEYFORTUS (nirsevimab-alip) Untitled letter · Broader use than approved

15 July 2026

Viatris Specialty: TOBI PODHALER (tobramycin inhalation powder) Untitled letter · Misleading dosing or convenience

13 July 2026

Lundbeck: Vyepti (eptinezumab-jjmr) Untitled letter · Overstated or unsupported efficacy

24 June 2026

Pinnacle Biologics: PHOTOFRIN (porfimer sodium) Untitled letter · Omits or minimizes risk, Risk not clear and conspicuous, Overstated or unsupported efficacy

22 June 2026

QOL Medical: Sucraid (sacrosidase) Untitled letter · Omits or minimizes risk, Risk not clear and conspicuous

26 May 2026

Letters by year

2026 (to 26 October 2026)

27

2025

73

2024

5

2023

5

2022

4

2021

6

2020

5

2019

10

2018

7

2017

3

Untitled and warning letters together. 52 untitled letters carry the date 9 September 2025.

Letters by quarter

Q4 2026 (so far)

1 (1 untitled, 0 warning)

Q3 2026

6 (5 untitled, 1 warning)

Q2 2026

8 (8 untitled, 0 warning)

Q1 2026

12 (11 untitled, 1 warning)

Q4 2025

4 (4 untitled, 0 warning)

Q3 2025

64 (56 untitled, 8 warning)

Counted by the date on each letter. The quarterly report, FDA drug promotion letters, Q3 2026, breaks the latest quarter down by format, audience and what FDA cited.

What FDA cited

Overstated or unsupported efficacy

88 letters

Omits or minimizes risk

72 letters

Risk not clear and conspicuous

62 letters

Broader use than approved

29 letters

Unsupported superiority or comparison

24 letters

Misleading dosing or convenience

21 letters

Missing required disclosure

16 letters

Not submitted on Form 2253

15 letters

A letter can carry several categories.

Letters by company

AstraZeneca

7 letters

Bristol Myers Squibb

5 letters

Eli Lilly

5 letters

Novartis

5 letters

AbbVie

4 letters

UCB

4 letters

Amgen

3 letters

BeOne Medicines

3 letters

Source: FDA's untitled letters page and its warning letter pages, read into a snapshot by a script. Violation categories are this tool's labels, assigned by a model reading each letter.

The Office of Prescription Drug Promotion (OPDP) is part of FDA's Center for Drug Evaluation and Research. FDA describes it as the office that regulates prescription drug promotion made by or on behalf of a manufacturer, packer or distributor. That covers TV and radio ads, printed material, websites and social media, speaker programs and sales presentations (FDA's Bad Ad Program page). Companies send promotional pieces to FDA on Form FDA 2253 when they first use them. OPDP reads some of them, and when it finds one false or misleading it writes to the company.

This database holds two kinds of letter. The first is every OPDP untitled letter on FDA's untitled letters page: 120 letters, dated 2017 to 26 October 2026. FDA moved earlier letters, 1997 to 2016, to its archive. The second is the 25warning letters whose subject is a company's promotion of a drug or biologic. FDA files those with all its other warning letters, under different issuing offices from year to year, so we picked them out by reading each one.

It leaves out warning letters to online pharmacies, compounders and sellers of unapproved products. Those are in the warning letter search. It also leaves out the thousands of letters FDA said it sent in September 2025 telling companies to review their advertising. FDA did not publish them.

Date

FDA's issued date for an untitled letter, and the letter date for a warning letter.

Company

The company the letter is addressed to, as the letter names it. Where FDA's table says a firm is a subsidiary of another, the letter is grouped under the parent.

Product and application

Brand and generic name, and the NDA, BLA or ANDA number from the letter's reference line.

Matter number

The MA number OPDP puts on its letters. The letter tells the company to quote it in all later correspondence.

Aimed at

Consumers (direct-to-consumer), healthcare professionals, or both.

Format

The kind of piece: TV ad, website, social post, exhibit booth, sales aid and so on. A letter can cover several.

What FDA cited

Up to eight violation categories, each backed by a sentence quoted from the letter. See the category list below.

Form FDA 2253 and Bad Ad Program

Whether the letter says the piece came in on Form FDA 2253, and whether it says FDA also received a complaint through the Bad Ad Program.

Close-out

The date of FDA's close-out letter, the days from the letter to the close-out, and a link to it.

Type a company, brand, generic name or application number. The box also reads the one-line summary and the category names, so “superiority” or “Instagram” works. Every word must match, so a second word narrows the list.

• Filter by what FDA cited to see every letter that raised, say, risk presentation.
• Filter by format and audience to read only TV ads, or only letters about professional sales aids.
• Tick “Closed out by FDA” to see which matters FDA considers resolved.

Tick “Search the full text of every letter” to search what the letters say. The tool then looks for your words in every sentence of every letter. Put a phrase in quotes to find it as written, so “individual results may vary” finds that sentence and not a letter that happens to use the four words apart. Case, hyphens and a plural “s” do not matter. All the words and phrases you enter must appear in the same letter, and each result shows the sentence that matched. The search runs in your browser. It downloads a text index of a few hundred kilobytes when you tick the box and not before.

The chips under the search box run the phrases reviewers ask about most. In the current data they find these letters:

• “individual results may vary”: 16 letters
• “major statement”: 41 letters, 40 of them untitled letters
• “single-arm”: 11 letters, 10 of them untitled letters
• “open-label”: 11 letters
• “exploratory”: 13 letters
• “quality of life”: 15 letters
• “boxed warning”: 34 letters, 17 of them untitled letters

“Individual results may vary” is the company's own on-screen disclaimer, quoted back to it. In nearly all of these letters FDA says the disclaimer does not mitigate the misleading impression. “Major statement” is the term 21 CFR 202.1(e)(1)(i)(A) gives to the major side effects and contraindications in a broadcast ad. It turns up in letters that say a TV ad did not present them in a clear, conspicuous and neutral manner.

The address bar updates with your filters, so a search can be linked. Each result opens a page for that letter with the quoted passages, the close-out and a link to the PDF on FDA.gov. The PDFs stay on FDA.gov, and a result shows only the sentences that match.

FDA describes a warning letter as its notice that it has found significant violations, one that asks for a response within a set time and may be followed by further action (About Warning and Close-Out Letters). An untitled letter is the same kind of document without the heading “Warning Letter”.

The letters in this database show the difference in what they say:

• 17 of 25 warning letters say that failing to correct the violations may bring regulatory action, including seizure or injunction. None of the 120 untitled letters says it.
• 104 of the 120 untitled letters ask for a written response within 15 working days. They ask the company to list every promotional piece with similar claims, with its 2253 submission date, and to explain how it will stop using them.
• Untitled letters close with the line that the letter “notifies you of our concerns and provides you with an opportunity to address them.”

Both are public, and a second letter about the same product is a pattern the next reader will notice. Several warning letters here open by recalling an earlier untitled letter on the same product.

Most OPDP letters follow one order.

• Opening paragraph.It names the piece FDA reviewed, says whether the company submitted it on Form FDA 2253, and states FDA's conclusion: the piece is false or misleading and so misbrands the drug. Older letters cite the law here: 21 U.S.C. 352(a) and (n), which are sections 502(a) and (n) of the FD&C Act, plus 321(n) and 331(a), and 21 CFR 202.1(e). Newer letters often leave the citations out.
• Background. The approved indication and the main risks from the prescribing information. This is the yardstick for the rest of the letter.
• The violations.Each opens with the claims FDA objects to, quoted with timestamps or frame numbers for video. Then comes FDA's reasoning, often in the form “we are not aware of data that would support” the suggestion. FDA routinely adds that a disclaimer such as “individual results may vary” does not fix the impression.
• Conclusion and requested action. The 15 working day response, the list of similar pieces, and the matter number. Every letter says the concerns are not necessarily a complete list, and that the company is responsible for compliance across its promotion.

The regulation under most of these letters is 21 CFR 202.1. It requires a true statement of side effects, contraindications and effectiveness in every prescription drug advertisement (paragraph (e)(1)). It says untrue or misleading content in one part of an ad is not cured by true content in another part ((e)(3)(i)). Section 502(n) of the Act is the statutory source (21 U.S.C. 352(n)).

These eight labels are ours. A model reads each letter against the list and quotes the sentence that supports each label. The regulation behind each is noted where the letters cite one.

• Omits or minimizes risk. The piece leaves out or plays down a warning, contraindication or side effect, or leaves a misleading impression of safety. 21 CFR 202.1(e)(1) and (e)(6).
• Risk not clear and conspicuous. The risk text is there but hard to notice or take in. For consumer TV ads, 202.1(e)(1)(ii) requires the major statement to be in consumer-friendly language, in audio and on-screen text at once, readable, and free of audio or visuals likely to interfere with understanding it. For print and web, 202.1(e)(7)(viii) asks for risk information with prominence and readability reasonably comparable to the benefit claims.
• Overstated or unsupported efficacy. Study data, endpoints, mechanism or quality-of-life claims that go beyond the evidence. Single-arm study results presented as time-to-event benefit are a recurring example in the 2025 letters.
• Unsupported superiority or comparison. Better, safer or faster than another drug without adequate head-to-head evidence.
• Broader use than approved. Suggests an indication, population, setting or dose the label does not support, or promotes a drug that is not yet approved. Letters about investigational drugs cite 21 CFR 312.7(a).
• Misleading dosing or convenience. Onset, ease of use, adherence or administration claims the label does not back.
• Missing required disclosure. No indication, no established name, no brief summary or adequate provision, or no boxed warning statement where the format needs one.
• Not submitted on Form 2253. The piece was not sent to FDA at first use. The rule is 21 CFR 314.81(b)(3)(i), applied to biologics by 601.12(f)(4).

A close-out letter is FDA's statement that it has evaluated the company's response. For untitled letters it says the evaluation is complete and that it appears the company addressed the violations. Then it adds that the letter does not relieve the company of responsibility for sustained compliance and does not rule out later action.

FDA's published close-out program describes warning letters, not untitled letters. It says a close-out issues only after FDA has verified the corrective actions, usually by follow-up inspection. Promotion letters rarely involve an inspection, so read this program text as background only.

FDA's table shows no close-out for any untitled letter dated before 8 March 2021, so for the 16 older letters we show the status as not published, not as never closed. Of the 104 untitled letters since then, 86 (83%) have a close-out letter, and the median wait from letter to close-out is 76 days. Letters from the last few months have not had time to be closed out, so the share understates what FDA will finish. A missing close-out does not mean FDA found the response unsatisfactory. FDA does not say.

• The categories are labels, not FDA findings. A model assigned them. We checked 22 letters by hand against the text: of 48 labels, 46 were right, and we found 3 the model missed. A second model agreed with the first on most labels. Treat the filters as a fast way to find letters, then read the letter.
• Only published letters are here. FDA said it sent thousands of letters in September 2025. The published untitled letters are a small share of them.
• Dates follow FDA's table. A few close-out letters cite a different date for the letter they close than the table does. We use the table date.
• Warning letters are selected by rule. A warning letter is included when OPDP issued it, or when it opens by saying FDA reviewed a promotional communication and cites the advertising provisions. An unusual letter could be missed.
• Scanned PDFs. Two close-out letters and one untitled letter have no usable text layer, so we read them with optical character recognition.

FDA offers the untitled letters as a web table and the PDFs behind it. It has no API. The dataset behind this page is public as JSON and as a spreadsheet (CSV). The scripts that build it, including the labeling prompt and the hand check, are in the scripts/opdp folder of this site's repository. For the analysis, see what OPDP cited in 2025 and 2026. For how few submitted pieces end in a letter, see promotional materials submitted against letters published. For the review process that sits upstream of these letters, see the MLR review guide and the glossary entries on untitled letters, the Office of Prescription Drug Promotion and Form FDA 2253. Many of the letters are about TV ads. One of the rules behind them is explained in FDA's plan to end adequate provision in TV and radio drug ads and in the glossary entry on adequate provision.

What is an FDA OPDP untitled letter?

A letter from the Office of Prescription Drug Promotion in FDA's drug center telling a company that a promotional piece for a prescription drug or biologic is false or misleading. It does not carry the heading "Warning Letter". It names the piece, the claims, and the rule it breaks, and it asks the company to stop using it and respond.

How is an untitled letter different from a warning letter?

FDA describes a warning letter as notice of significant violations. Many warning letters in this database end with a sentence saying failure to correct may bring regulatory action such as seizure or injunction (17 of 25). None of the 120 untitled letters contains it. 104 of the 120 ask for a written response within 15 working days.

How many OPDP untitled letters has FDA published?

120 on FDA's untitled letters page as of 11 November 2026, dated 2017 to 26 October 2026. FDA lists 5 for 2024 and 63 for 2025. FDA's page says earlier years are in its archive.

Why are there so many letters in 2025?

On 9 September 2025 FDA announced a crackdown on direct-to-consumer drug advertising and said it was sending thousands of letters to drug companies and about 100 cease-and-desist letters. 52 of the published untitled letters carry the date 9 September 2025. Most of the thousands of letters FDA mentioned are not public, so this database cannot show them.

Does this database include warning letters?

It includes 25 warning letters whose subject is a company's promotion of a drug or biologic. They come from FDA's warning letter pages. It leaves out warning letters to online pharmacies, compounders and sellers of unapproved products, which the warning letter search covers.

What does a close-out letter mean?

FDA's close-out letter says it evaluated the company's response and it appears the company addressed the violations. It also says the letter does not relieve the company of responsibility for compliance and does not stop later action. It is not a clearance of the piece.

How fast does FDA close out untitled letters?

86 of 104 untitled letters have a published close-out letter, counting untitled letters dated since 8 March 2021, when FDA's table starts listing them. The median gap from letter to close-out is 76 days. Recent letters have had less time to be closed out, so the share will rise.

How were the violation categories assigned?

A language model read each letter against a fixed list of eight categories and quoted the sentence that supports each one. A script checks that every quote appears in the letter. We then checked 22 letters by hand: of 48 category labels, 46 were right, and we found 3 that should have been added. The labels are ours, not FDA's, and the method is in the scripts/opdp folder of this site's repository.

How often is the database updated?

It is rebuilt from FDA's pages when new letters appear, and the data block shows when it last ran. The newest letter in it is dated 26 October 2026. A letter FDA posted in the last few days may not be in yet.

Can I search for a phrase in the letters themselves?

Yes. Tick "Search the full text of every letter" and type a word or a phrase. Put the phrase in quotes, for example "individual results may vary" or "major statement", to find it as written in one sentence. Every word and phrase you enter must appear in the same letter, and each result shows the sentence that matched. The search runs in your browser on a text index that downloads when you tick the box.

Is there an API or a download?

FDA publishes no API or data file for these letters, only a table. The dataset behind this tool is public as JSON at arca.inc/data/opdp-letters.json and as a spreadsheet at arca.inc/data/opdp-letters.csv.

How do I report a promotional piece to FDA?

Through FDA's Bad Ad Program, run by OPDP: email BadAd@fda.gov or call 855-RX-BADAD. Anyone can report, and reports can be anonymous. Several letters in this database say FDA received a complaint through the program.

The full list without filters, for readers who prefer a page to a search box. Each entry opens the letter's own page.

• 26 October 2026: Vanda Pharmaceuticals, Nereus (tradipitant) (untitled letter)
• 28 September 2026: Evolus, JEUVEAU (prabotulinumtoxina-xvfs) (untitled letter)
• 21 August 2026: Alar Pharmaceuticals, ALA-3000 (ketamine pamoate) (untitled letter)
• 12 August 2026: Amgen, Vectibix (panitumumab) (warning letter)
• 28 July 2026: Travere Therapeutics, FILSPARI (sparsentan) (untitled letter)
• 15 July 2026: Sanofi, BEYFORTUS (nirsevimab-alip) (untitled letter)
• 13 July 2026: Viatris Specialty, TOBI PODHALER (tobramycin inhalation powder) (untitled letter)
• 24 June 2026: Lundbeck, Vyepti (eptinezumab-jjmr) (untitled letter)
• 22 June 2026: Pinnacle Biologics, PHOTOFRIN (porfimer sodium) (untitled letter)
• 26 May 2026: QOL Medical, Sucraid (sacrosidase) (untitled letter)
• 12 May 2026: BeOne Medicines, BRUKINSA (zanubrutinib) (untitled letter)
• 28 April 2026: Bayer HealthCare Pharmaceuticals, NUBEQA (darolutamide) (untitled letter)
• 23 April 2026: Alnylam Pharmaceuticals, AMVUTTRA (vutrisiran) (untitled letter)
• 22 April 2026: Incyte, Niktimvo (axatilimab-csfr) (untitled letter)
• 8 April 2026: Pfizer, ADCETRIS (brentuximab vedotin) (untitled letter)
• 31 March 2026: Amneal Pharmaceuticals, ALYMSYS (bevacizumab-maly) (untitled letter)
• 27 March 2026: BioCorRx Pharmaceuticals, LUCEMYRA (lofexidine) (untitled letter)
• 13 March 2026: ImmunityBio, ANKTIVA (nogapendekin alfa inbakicept-pmln) (warning letter)
• 26 February 2026: Novo Nordisk, OZEMPIC (semaglutide) (untitled letter)
• 6 February 2026: Sobi, VONJO (pacritinib) (untitled letter)
• 6 February 2026: Johnson & Johnson, TREMFYA (guselkumab) (untitled letter)
• 5 February 2026: Novo Nordisk, Wegovy (untitled letter)
• 30 January 2026: argenx, VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) (untitled letter)
• 30 January 2026: argenx, VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) (untitled letter)
• 23 January 2026: ARS Pharmaceuticals, NEFFY (epinephrine nasal spray) (untitled letter)
• 7 January 2026: ImmunityBio, ANKTIVA (nogapendekin alfa inbakicept-pmln) (untitled letter)
• 7 January 2026: BeOne Medicines, BRUKINSA (zanubrutinib) (untitled letter)
• 19 December 2025: Esperion Therapeutics, NEXLIZET (bempedoic acid and ezetimibe) (untitled letter)
• 15 December 2025: Bristol Myers Squibb, COBENFY (xanomeline and trospium chloride) (untitled letter)
• 15 December 2025: BeOne Medicines, TEVIMBRA (tislelizumab-jsgr) (untitled letter)
• 24 November 2025: Daiichi Sankyo, TURALIO (pexidartinib) (untitled letter)
• 30 September 2025: SK Life Science, Xcopri (cenobamate) (untitled letter)
• 30 September 2025: PharmaTher, Ketamine (untitled letter)
• 23 September 2025: Novartis, FABHALTA (iptacopan) (untitled letter)
• 23 September 2025: AstraZeneca, FARXIGA (dapagliflozin) (untitled letter)
• 9 September 2025: UCB, RYSTIGGO (rozanolixizumab-noli) (untitled letter)
• 9 September 2025: UCB, BIMZELX (bimekizumab-bkzx) (untitled letter)
• 9 September 2025: UCB, BIMZELX (bimekizumab-bkzx) (untitled letter)
• 9 September 2025: UCB, BIMZELX (bimekizumab-bkzx) (untitled letter)
• 9 September 2025: Teva Neuroscience, AUSTEDO XR (deutetrabenazine) (untitled letter)
• 9 September 2025: Teva Neuroscience, AUSTEDO XR (deutetrabenazine) (untitled letter)
• 9 September 2025: Takeda, ICLUSIG (ponatinib) (untitled letter)
• 9 September 2025: Takeda, FRUZAQLA (fruquintinib) (untitled letter)
• 9 September 2025: Takeda, FRUZAQLA (fruquintinib) (untitled letter)
• 9 September 2025: Supernus Pharmaceuticals, Qelbree (viloxazine extended-release capsules) (untitled letter)
• 9 September 2025: Supernus Pharmaceuticals, Qelbree (viloxazine extended-release capsules) (untitled letter)
• 9 September 2025: Sanofi, TZIELD (teplizumab-mzwv) (untitled letter)
• 9 September 2025: Pinnacle Biologics, PHOTOFRIN (porfimer sodium) (untitled letter)
• 9 September 2025: Pinnacle Biologics, PHOTOFRIN (porfimer sodium) (untitled letter)
• 9 September 2025: Phathom Pharmaceuticals, VOQUEZNA (vonoprazan) (untitled letter)
• 9 September 2025: Phathom Pharmaceuticals, VOQUEZNA (vonoprazan) (untitled letter)
• 9 September 2025: Phathom Pharmaceuticals, VOQUEZNA (vonoprazan) (untitled letter)
• 9 September 2025: Pfizer, VELSIPITY (etrasimod) (untitled letter)
• 9 September 2025: Novo Nordisk, Wegovy (semaglutide) (warning letter)
• 9 September 2025: Novartis, PLUVICTO (lutetium lu 177 vipivotide tetraxetan) (untitled letter)
• 9 September 2025: Novartis, KISQALI (ribociclib) (untitled letter)
• 9 September 2025: Novartis, Kesimpta (ofatumumab) (untitled letter)
• 9 September 2025: Neurocrine Biosciences, INGREZZA (valbenazine) (untitled letter)
• 9 September 2025: Nalpropion Pharmaceuticals, Contrave (naltrexone hydrochloride and bupropion hydrochloride) (untitled letter)
• 9 September 2025: Ipsen Biopharmaceuticals, TAZVERIK (tazemetostat) (untitled letter)
• 9 September 2025: Incyte, PEMAZYRE (pemigatinib) (untitled letter)
• 9 September 2025: ImmunityBio, ANKTIVA (nogapendekin alfa inbakicept-pmln) (untitled letter)
• 9 September 2025: GlaxoSmithKline, APRETUDE (cabotegravir extended-release injectable suspension) (untitled letter)
• 9 September 2025: Galderma, NEMLUVIO (nemolizumab-ilto) (untitled letter)
• 9 September 2025: Evolus, JEUVEAU (prabotulinumtoxina-xvfs) (untitled letter)
• 9 September 2025: Eli Lilly, Zepbound and Mounjaro (tirzepatide) (warning letter)
• 9 September 2025: Eli Lilly, Zepbound (tirzepatide) (warning letter)
• 9 September 2025: Eli Lilly, ZEPBOUND (tirzepatide) (warning letter)
• 9 September 2025: CSL Behring, HIZENTRA (immune globulin subcutaneous (human)) (warning letter)
• 9 September 2025: Bristol Myers Squibb, Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) (untitled letter)
• 9 September 2025: Bristol Myers Squibb, Opdivo and Yervoy (nivolumab and ipilimumab) (untitled letter)
• 9 September 2025: Bristol Myers Squibb, CAMZYOS (mavacamten) (untitled letter)
• 9 September 2025: BridgeBio Pharma, ATTRUBY (acoramidis) (untitled letter)
• 9 September 2025: Boehringer Ingelheim, JARDIANCE (empagliflozin) (untitled letter)
• 9 September 2025: Boehringer Ingelheim, JARDIANCE (empagliflozin) (untitled letter)
• 9 September 2025: Boehringer Ingelheim, JARDIANCE (empagliflozin) (untitled letter)
• 9 September 2025: Bausch Health, JUBLIA (efinaconazole) (untitled letter)
• 9 September 2025: Azurity Pharmaceuticals, DANZITEN (nilotinib) (untitled letter)
• 9 September 2025: Aytu Biopharma, Cotempla XR-ODT (methylphenidate) (warning letter)
• 9 September 2025: Aytu Biopharma, Adzenys XR-ODT (amphetamine) (warning letter)
• 9 September 2025: Axsome Therapeutics, AUVELITY (dextromethorphan hydrobromide and bupropion hydrochloride) (untitled letter)
• 9 September 2025: AstraZeneca, TRUQAP (capivasertib) (untitled letter)
• 9 September 2025: AstraZeneca, FASENRA (benralizumab) (untitled letter)
• 9 September 2025: AstraZeneca, FASENRA (benralizumab) (untitled letter)
• 9 September 2025: AstraZeneca, FASENRA (benralizumab) (untitled letter)
• 9 September 2025: AstraZeneca, CALQUENCE (acalabrutinib) (untitled letter)
• 9 September 2025: ARS Pharmaceuticals, NEFFY (epinephrine nasal spray) (untitled letter)
• 9 September 2025: Amgen, IMDELLTRA (tarlatamab-dlle) (untitled letter)
• 9 September 2025: Alora Pharmaceuticals, RELEXXII (methylphenidate hydrochloride) (warning letter)
• 9 September 2025: Alnylam Pharmaceuticals, AMVUTTRA (vutrisiran) (untitled letter)
• 9 September 2025: Alexion Pharmaceuticals, ULTOMIRIS (ravulizumab-cwvz) (untitled letter)
• 9 September 2025: AbbVie, SKYRIZI (risankizumab-rzaa) (untitled letter)
• 9 September 2025: AbbVie, Qulipta (atogepant) (untitled letter)
• 9 September 2025: AbbVie, LINZESS (linaclotide) (untitled letter)
• 9 September 2025: Aadi Bioscience, FYARRO (sirolimus protein-bound particles for injectable suspension (albumin-bound)) (untitled letter)
• 29 May 2025: Sprout Pharmaceuticals, Addyi (flibanserin) (warning letter)
• 28 April 2025: Mayne Pharma, NEXTSTELLIS (drospirenone and estetrol) (untitled letter)
• 25 April 2025: Sarfez, SOAANZ (torsemide) (warning letter)
• 21 March 2025: Taiho Oncology, LYTGOBI (futibatinib) (untitled letter)
• 3 February 2025: Edenbridge Pharmaceuticals, HEMADY (dexamethasone) (untitled letter)
• 31 October 2024: Merz Pharmaceuticals, Xeomin (incobotulinumtoxina) (untitled letter)
• 29 August 2024: AbbVie, UBRELVY (ubrogepant) (untitled letter)
• 1 August 2024: Bristol Myers Squibb, KRAZATI (adagrasib) (untitled letter)
• 17 July 2024: kaleo, AUVI-Q (epinephrine injection) (untitled letter)
• 18 January 2024: Novartis, Kisqali (ribociclib) (untitled letter)
• 31 October 2023: Otsuka Pharmaceutical Development and Commercialization, Rexulti (brexpiprazole) (untitled letter)
• 31 October 2023: Evofem Biosciences, Phexxi (untitled letter)
• 11 August 2023: Exeltis, SLYND (drospirenone) (untitled letter)
• 4 August 2023: AstraZeneca, BREZTRI AEROSPHERE (budesonide, glycopyrrolate, and formoterol fumarate) (warning letter)
• 7 June 2023: Xeris Pharmaceuticals, Recorlev (levoketoconazole) (untitled letter)
• 2 June 2022: Althera Pharmaceuticals, Roszet (rosuvastatin and ezetimibe) (untitled letter)
• 31 March 2022: Bausch Health, DUOBRII (halobetasol propionate and tazarotene) (untitled letter)
• 11 February 2022: CytoDyn, leronlimab (warning letter)
• 19 January 2022: Eli Lilly, TRULICITY (dulaglutide) (untitled letter)
• 13 December 2021: Eli Lilly, EMGALITY (galcanezumab-gnlm) (untitled letter)
• 9 August 2021: Eton Pharmaceuticals, ALKINDI SPRINKLE (hydrocortisone) (untitled letter)
• 7 July 2021: Amgen, Neulasta (pegfilgrastim) (untitled letter)
• 8 March 2021: Biohaven Pharmaceuticals, Nurtec ODT (rimegepant) (untitled letter)
• 12 February 2021: CooperSurgical, Paragard (intrauterine copper contraceptive) (warning letter)
• 11 February 2021: AcelRx Pharmaceuticals, DSUVIA (sufentanil) (warning letter)
• 24 November 2020: Azurity Pharmaceuticals, XATMEP (methotrexate) (untitled letter)
• 22 September 2020: Nephron, Budesonide Inhalation Suspension (budesonide) (warning letter)
• 31 August 2020: Sprout Pharmaceuticals, Addyi (flibanserin) (warning letter)
• 14 August 2020: Xeris Pharmaceuticals, Gvoke (glucagon) (untitled letter)
• 21 February 2020: Outlook Pharmaceuticals, ProCentra (dextroamphetamine sulfate) (warning letter)
• 2 December 2019: Alkermes, VIVITROL (naltrexone for extended-release injectable suspension) (warning letter)
• 18 November 2019: Rockwell Medical, Triferic (ferric pyrophosphate citrate) (untitled letter)
• 1 November 2019: Nascent Biotech, Pritumumab (untitled letter)
• 24 September 2019: Kowa Pharmaceuticals, LIVALO (pitavastatin) (untitled letter)
• 13 September 2019: Galt Pharmaceuticals, DORAL (quazepam) (warning letter)
• 16 August 2019: Metuchen Pharmaceuticals, Stendra (avanafil) (warning letter)
• 25 July 2019: CooperSurgical, ParaGard (intrauterine copper contraceptive) (untitled letter)
• 14 June 2019: Aclaris Therapeutics, ESKATA (hydrogen peroxide) (untitled letter)
• 22 May 2019: VIVUS, QSYMIA (phentermine and topiramate extended-release) (untitled letter)
• 15 February 2019: Phoenix Molecular Imaging, 11C-Acetate (untitled letter)
• 22 October 2018: Vanda Pharmaceuticals, Fanapt and Hetlioz (iloperidone and tasimelteon) (warning letter)
• 11 October 2018: Eisai, Fycompa (perampanel) (untitled letter)
• 5 October 2018: MannKind, AFREZZA (insulin human) (warning letter)
• 16 August 2018: ASCEND Therapeutics, EstroGel (estradiol) (untitled letter)
• 28 June 2018: Arog Pharmaceuticals, Crenolanib (untitled letter)
• 19 June 2018: Pfizer, ESTRING (estradiol vaginal ring) (untitled letter)
• 9 February 2018: Collegium Pharmaceutical, XTAMPZA ER (oxycodone) (untitled letter)
• 28 December 2017: UCLA, Ga68-PSMA (untitled letter)
• 24 August 2017: Cipher Pharmaceuticals, ConZip (tramadol hydrochloride) (warning letter)
• 18 May 2017: Orexigen Therapeutics, CONTRAVE (naltrexone hcl and bupropion hcl) (untitled letter)