Opportunity
Federal Register #2026-20762
FDA withdrawal of approval for 37 abbreviated new drug applications
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 09, 2026
Identifier
2026-20762
The FDA notice withdraws approval of 37 abbreviated new drug applications (ANDAs); it is a regulatory action, not a procurement opportunity. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Named applicants and related companies: Par Health USA LLC, U.S. agent for PH Health Limited; Watson Laboratories, Inc. and Barr Laboratories, LLC, identified as indirect, wholly owned subsidiaries of Teva Pharmaceuticals USA, Inc.; Fosun Pharma USA Inc.; Lachman Consultant Services, Inc., U.S. agent for Heather Drug Company; and Nukemed, Inc., doing business as SpectronRx. - Affected products: The applications include medicines such as ibuprofen, nifedipine, fluoxetine, fexofenadine and fexofenadine/pseudoephedrine, hormonal contraceptives, levetiracetam, ciprofloxacin, prednisolone, diphenhydramine, acetaminophen/codeine, butalbital/aspirin/caffeine, bupropion, radiopharmaceuticals, and bosentan. The notice does not provide product quantities or part numbers. - Reason and effect: The applicants reported that the associated products were no longer marketed and requested withdrawal of the applications. Withdrawal is without prejudice to refiling; certain existing inventory may continue to be dispensed until depleted, expired, or otherwise ineligible for distribution. - Procurement relevance: No products or services are being solicited for purchase, and no contract value or performance period is specified.
Description
The Food and Drug Administration is withdrawing approval of 37 abbreviated new drug applications from multiple applicants. The applicants notified FDA in writing that the drug products were no longer marketed and requested withdrawal of approval. Approval is withdrawn effective November 9, 2026. The notice states that withdrawal is without prejudice to refiling and specifies that certain existing inventory may continue to be dispensed until depleted, expired, or otherwise violative.