Federal Register #2026-09011

FDA Regulatory Notice on MICARDIS (Telmisartan) and Withdrawal of Multiple Generic Drug Approvals

This FDA notice addresses the regulatory status of several prescription drug products: - The Food and Drug Administration (FDA), part of the Department of Health and Human Services, confirms that MICARDIS (telmisartan) tablets, 20 mg and 80 mg, were not withdrawn from sale for safety or effectiveness reasons - Original Equipment Manufacturer (OEM): Boehringer Ingelheim (holder of NDA 020850) - MICARDIS is indicated for hypertension and cardiovascular risk reduction in patients unable to take ACE inhibitors - This determination allows continued approval of generic (ANDA) applications referencing MICARDIS, provided all legal and regulatory requirements are met - The FDA is also withdrawing approval of 15 abbreviated new drug applications (ANDAs) from various applicants for other drugs, including: - Finasteride, Cilostazol, Amlodipine besylate, Carboplatin injectable, Ciprofloxacin extended-release, Ezetimibe, Anastrozole, Chlorzoxazone, Pantoprazole sodium delayed-release, Irbesartan and hydrochlorothiazide, Ibandronate sodium injectable, Dimethyl fumarate delayed-release, Esomeprazole magnesium delayed-release, and Ketorolac tromethamine - Notable applicants include Teva Pharmaceuticals USA, Inc., Par Health USA LLC., CHEMI S.p.A., Sawai USA, Inc., Cisen Pharmaceutical Co., Ltd., and Atnahs Pharma US Limited - No specific procurement, purchase quantities, or part numbers are provided for new acquisitions - The products remain listed in the FDA Orange Book's Discontinued Drug Product List for reasons other than safety or effectiveness - No new government purchase or contract is announced in this notice

Description

The Food and Drug Administration (FDA) has determined that MICARDIS (telmisartan), tablets, 20 mg and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not withdraw approval of the abbreviated new drug applications (ANDAs) that refer to these products and will continue to approve ANDAs that meet legal and regulatory requirements. MICARDIS is indicated for the treatment of hypertension and cardiovascular risk reduction in patients unable to take ACE inhibitors. The drug products are currently listed in the Discontinued Drug Product List section of the Orange Book, which includes drugs discontinued for reasons other than safety or effectiveness.

View original listing