Opportunity
Federal Register #FDA-2026-N-3445
FDA Withdrawal of Approval for Three Drug Applications (ANDAs)
Buyer
Food and Drug Administration
Posted
April 24, 2026
Identifier
FDA-2026-N-3445
This notice announces the FDA's withdrawal of approval for three abbreviated new drug applications (ANDAs): - Government buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and vendors: - Ambix Laboratories (Bacitracin-neomycin sulfate-polymyxin B sulfate ointment) - Egis Pharmaceuticals Ltd. (Captopril tablets, Piroxicam capsules) - Products/services affected: - Bacitracin-neomycin sulfate-polymyxin B sulfate ointment with diperodon hydrochloride (ANDA 060453) - Captopril tablets, 12.5 mg, 25 mg, 50 mg, 100 mg (ANDA 074748) - Piroxicam capsules, 10 mg and 20 mg (ANDA 074808) - Notable requirements: - Withdrawal is due to repeated failure to file required annual reports by the ANDA holders - Action is regulatory in nature, not a procurement or solicitation
Description
The Food and Drug Administration (FDA) is withdrawing approval of three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The withdrawal is due to the holders repeatedly failing to file required annual reports for these ANDAs. The approval is withdrawn as of April 24, 2026. The notice includes details about the specific ANDAs and the legal basis for the withdrawal under the Federal Food, Drug, and Cosmetic Act.