Opportunity
Federal Register #2026-09012
FDA Withdrawal of Approval for 15 Generic Drug Applications from Multiple Manufacturers
Buyer
Food and Drug Administration
Posted
May 07, 2026
Identifier
2026-09012
The Food and Drug Administration (FDA), under the Department of Health and Human Services, is withdrawing approval for 15 Abbreviated New Drug Applications (ANDAs) from multiple pharmaceutical manufacturers: - Government Buyer: - Food and Drug Administration (FDA), Center for Drug Evaluation and Research - OEMs and Vendors: - Teva Pharmaceuticals USA, Inc. - Actavis Elizabeth LLC - Watson Laboratories, Inc. - Pharmachemie B.V. - Par Health USA LLC - Pliva Lachema AS - Barr Laboratories LLC - Actavis Totowa LLC - Freyr INC. - Upsher-Smith Laboratories, LLC - The WhiteOak Group, LLC - Parexel International - Products/Drugs Withdrawn (all strengths and dosage forms): - Finasteride tablet (ANDA 076905) - Cilostazol tablet (ANDA 077028) - Amlodipine besylate tablet (ANDA 077671) - Carboplatin injectable (ANDA 077679, ANDA 078631) - Ciprofloxacin extended-release tablet (ANDA 078166) - Ezetimibe tablet (ANDA 078724) - Anastrozole tablet (ANDA 078984) - Chlorzoxazone tablet (ANDA 089895) - Pantoprazole sodium delayed-release tablet (ANDA 090797) - Irbesartan and hydrochlorothiazide tablet (ANDA 091539) - Ibandronate sodium injectable (ANDA 202235) - Dimethyl fumarate delayed-release capsule (ANDA 210285) - Esomeprazole magnesium delayed-release pellets capsule (ANDA 213158) - Ketorolac tromethamine tablet (ANDA 216407) - Notable Requirements: - Withdrawal applies to all strengths and dosage forms of the listed drugs - These products are no longer marketed by the applicants - Introduction or delivery of these products into interstate commerce without an approved application is prohibited - No procurement or contract award is being announced; this is a regulatory action
Description
The Food and Drug Administration (FDA) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. The withdrawal of approval is effective as of June 8, 2026. This action includes all amendments and supplements to the applications and applies to all strengths and dosage forms of the drugs listed.