United Therapeutics FDA records
1 original NDA and BLA approval, 0 warning letters and 0 drug recall events in FDA records since 2022. Each record below links to FDA.
- Headquarters: United States
- Complete response letters: 0
- OPDP letters: 0
- Inspections classified: 3, 0 OAI
- Class I recall events: 0
- Newest record: 2026-11-03
FDA Records by Year
2022 to 2026. Darker cells are the year with more records in that row.
| Source | 2022 | 2023 | 2024 | 2025 | 2026to date | Total |
|---|---|---|---|---|---|---|
| Original NDA and BLA approvals | 1 | 0 | 0 | 0 | 0 | 1 |
| Complete response lettersLetters before 2025 are incomplete | 0 | 0 | 0 | 0 | 0 | 0 |
| Warning letters | 0 | 0 | 0 | 0 | 0 | 0 |
| OPDP letters | 0 | 0 | 0 | 0 | 0 | 0 |
| Drug recall events | 0 | 0 | 0 | 0 | 0 | 0 |
| Inspections classifiedBy FDA fiscal year, which ends 30 September | 0 | 0 | 1 | 2 | 0 | 3 |
Latest Records
Newest first across all sources, each linked to FDA| Date | Record | Source | State |
|---|---|---|---|
| United Therapeutics CorporationDurham, North Carolina, United States · Drug Quality Assurance | Inspections | VAI | |
| United Therapeutic CorporationBeltsville, Maryland, United States · Drug Quality Assurance | Inspections | VAI | |
| United Therapeutics CorporationSilver Spring, Maryland, United States · Drug Quality Assurance | Inspections | VAI | |
| Tyvaso dpiNDA 214324 · UNITED THERAP | Approvals | ||
| TreprostinilNDA 214324 · Facility inspections | CRLs | Later approved | |
| Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation…Defective Delivery System: Water ingress through the lower water cup sensor of the device. | Recalls | Class III | |
| RemodulinNDA 208276 · UNITED THERAP | Approvals | ||
| TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso…CGMP Deviations | Recalls | Class II |
Search warning lettersSearch complete response lettersSearch OPDP lettersSearch drug recallsSearch inspections
Matched firm names include United Therapeutics. Not Unither Manufacturing or Laboratoire Unither. The search tools match the text you enter, so they can show names this page does not attribute. Counts are public-record facts attributed by firm name; they say nothing about how United Therapeutics compares with other companies. Methods and coverage · Updated Nov 12, 2026
Methods and coverage
Why this company is listed and how records are counted
Why listed: Fiscal 2025 revenue US$3.18 billion (Form 10-K, SEC XBRL company facts). Counts are for the five calendar years 2022 to 2026 (the last one to date); inspections use FDA fiscal years. All 53 companies use the same method.
How FDA records are matched to a company
FDA names the firm on every record in its own way: "Pfizer Inc.", "Hospira, Inc.", "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.". A record belongs to a company when the firm name contains that company's name or the name of a subsidiary it owns today, as whole words, or equals a short name we reviewed one by one (such as "Lilly" or "Merck" in Drugs@FDA). A record is counted under the entity FDA names, for all dates, so a record from before an acquisition is counted with the current owner. A name that two companies could claim is left out of both, so counts can be lower than a company's true total.
The full matching table is a CSV. These are the names we left out on purpose:
| Name in FDA records | Why it is not attributed |
|---|---|
| Watson Laboratories, Actavis (all forms) | Owned by Teva today, but the Actavis name also covers the branded business that went to AbbVie. A name without "Teva" in it is not attributed. |
| ViiV Healthcare | GSK holds 78.3%, with Pfizer and Shionogi as shareholders. Left unattributed. |
| Johnson & Johnson Consumer, Kenvue | The consumer business became Kenvue in 2023. |
| Novartis Consumer Health, GSK Consumer Healthcare, Wyeth Consumer, Chattem Sanofi | Consumer health units that moved out of the parent (to GSK and then Haleon, or to Opella). Not attributed to either side. |
| Bausch + Lomb | A separately listed company, 88% owned by Bausch Health. |
| Otsuka ICU Medical | A joint venture, not an Otsuka subsidiary. |
| Zydus Hospira Oncology | A joint venture, not a Pfizer subsidiary. |
| Westwood-Squibb | Shares a name origin with Bristol Myers Squibb but is a separate company. |
| Taro Pharmaceutical, Sun Pharma Advanced Research Company | Sun Pharma affiliates that are separate legal and listed entities under their own names. |
| Merck Teknika | Could not be tied to Merck KGaA or to Merck & Co. from FDA's data. |
| GlaxoSmithKline Nebraska | Could not tell whether the site belonged to the pharma or the consumer business. |
| Johnson & Johnson Private Limited (India) | A consumer products entity as far as FDA's name shows; left unattributed. |
| Roxane Laboratories | Boehringer Ingelheim sold its Roxane generics business to Hikma in 2016, but "Boehringer Ingelheim Roxane" also appears under Boehringer's own name. A name with only "Roxane" in it is not attributed. |
| AvKARE, Kashiv Biosciences | Amneal affiliates that appear under their own names; the ownership at each record's date was not checked. |
| Kyowa Hakko Bio, Kyowa Chemical Industry | Separate companies that share the Kyowa name, not part of Kyowa Kirin's pharma business. |
| Unither Manufacturing, Laboratoire Unither | A name shared with a French company; the link to United Therapeutics was not confirmed from FDA's data. |
What each source covers and leaves out
- Approvals
- Original NDA and BLA applications with an approved original submission in Drugs@FDA, counted by the approval date. Drugs@FDA lists the company that holds the application today, not the one that held it at approval. It covers many, not all, therapeutic biologics, so BLA counts are incomplete. Supplements, tentative approvals and generic (ANDA) approvals are not counted. Applications of every kind count, including 505(b)(2) and older molecules, so this is not a count of new molecular entities. Source: Original NDA and BLA approvals. openFDA Drugs@FDA, collected daily.
- Complete response letters
- Letters FDA has published in the openFDA transparency dataset. FDA released more than 200 letters on 10 July 2025, all from 2020 to 2024 and all for products later approved. It added 89 letters for applications that were not approved on 4 September 2025 and says it now publishes new letters promptly. Years before 2025 therefore hold only some of the letters FDA sent, and a count of zero does not mean no letter was issued. Source: Complete response letters. openFDA transparency CRL dataset, collected daily.
- Warning letters
- Warning letters from CDER, CDRH and CBER on FDA's site, from a saved snapshot of FDA's pages that FDA's own site does not offer as data. Tobacco, food and veterinary letters are excluded. Coverage starts in 2017. A letter is counted under the firm name it was addressed to, so letters to a contract site that does not carry the company's name are not attributed. Letters about drug promotion also appear in the OPDP count. Source: Warning letters. FDA warning letter pages, snapshot refreshed weekly.
- OPDP letters
- Untitled letters and warning letters from FDA's Office of Prescription Drug Promotion, from May 2017. They concern specific promotional pieces. A promotion warning letter can appear both here and in the warning letter count, so the two counts are not added together. Source: OPDP untitled and warning letters. FDA OPDP letter pages, snapshot refreshed weekly.
- Drug recalls
- Human drug recalls in FDA's enforcement reports through openFDA, counted once per recall event by initiation date. One event can cover many products and lots. Device recalls are not counted, so a company that also makes devices is shown for its drugs only. FDA's class describes the recall's risk, and FDA classifies a recall after the firm starts it. Source: Drug recall events. openFDA drug enforcement reports, collected daily.
- Inspections
- Drug and biologic inspections that FDA has classified, from the FDA Data Dashboard, by FDA fiscal year (1 October to 30 September). An inspection that covers several project areas is counted once at its most serious classification. The counts include clinical investigator and bioresearch monitoring inspections, blood and plasma centers and sites abroad, so a plasma business shows many inspections. NAI is no action indicated, VAI voluntary action indicated and OAI official action indicated. Device inspections are not counted. Source: Inspections classified. FDA Data Dashboard, collected daily.
- Debarments
- FDA's debarment lists name individuals, not companies, so no listed company has a debarment record here.
Work from public records like these
Arca is building an enterprise agent OS for life sciences. Its agents research questions and draft documents from a team's own records, with each claim linked to its source.