FDA Plays Marie Kondo With 20 Dead Generic Drugs
Published Date: 12/12/2025
Notice
Summary
The FDA is officially pulling the plug on 20 drug approvals because the companies, including Pfizer and Monarch Pharmaceuticals, told the FDA they stopped selling these medicines. This change kicks in on January 12, 2026, but companies can apply again if they want. No money penalties here—just a cleanup to keep the drug list fresh and accurate.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Approval Withdrawn for 20 Drug ANDAs
The FDA is withdrawing approval of 20 abbreviated new drug applications (ANDAs) as of January 12, 2026. The notice lists specific products (for example, TAPAZOLE tablets, several NEOSPORIN formulations, Gentamicin sulfate injectables, ADRIAMYCIN PFS, Pancuronium Bromide, and others) whose approvals are withdrawn at that date.
Existing Inventory May Still Be Dispensed
Products listed in the withdrawal table that are in inventory on January 12, 2026 may continue to be dispensed until inventories are depleted, reach their expiration dates, or otherwise become violative, whichever occurs first. This allows existing stock to remain available to patients until those limits are reached.
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Key Dates
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