Opportunity
Federal Register #FDA-2026-N-6809
FDA Withdraws Approval for 34 Drug Applications from Multiple Manufacturers
Buyer
Food and Drug Administration
Posted
July 06, 2026
Identifier
FDA-2026-N-6809
The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has announced the withdrawal of approval for 34 new drug applications (NDAs) from multiple pharmaceutical manufacturers. - OEMs (Manufacturers) involved: - Endo Operations Limited - Monarch Pharmaceuticals (Pfizer) - Janssen Pharmaceuticals - GlaxoSmithKline - Teva - Acrotech Biopharma - Fougera Pharmaceuticals - Allergan - Sanofi-Aventis - EMD Serono - Hoffmann-La Roche (Genentech) - Viiv Healthcare - AbbVie - Actelion Pharmaceuticals - Cephalon (Teva) - Horizon Therapeutics - Innocoll Pharmaceuticals - Eli Lilly - Others - Products affected: - Percodan - Septra - Haldol - Rythmol - Alphagan - Flomax - Sporanox - Prefest - Euthyrox - Fuzeon - Lexivia - Zemplar - TriCor - Ventavis - Fentora - Rapaflo - Trilipix - Vimovo - Doxorubicin Hydrochloride - Oxycodone Hydrochloride - Rayos - Pennsaid - Posimir - Carnexiv - Dsuvia - Xaracoll - Reyvow - And others - All strengths and dosage forms included in the applications are affected, even if not explicitly listed - The withdrawal was requested by the applicants because the drugs are no longer marketed - This is an administrative action regarding drug approvals, not a procurement or award opportunity
Description
The Food and Drug Administration (FDA) is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants. The applicants notified the FDA that the drug products are no longer marketed and requested withdrawal of approval. The withdrawal is effective as of August 5, 2026. This action includes all amendments and supplements to the applications listed.