37 Generic Drugs Yanked for Lack of Sales
Published Date: 10/9/2026
Notice
Summary
The FDA is officially pulling the plug on 37 generic drug approvals because the companies told them these drugs aren’t being sold anymore. This change kicks in on November 9, 2026, and it won’t stop companies from trying again later if they want. This mostly affects Par Health USA and a few others, so no more of these specific meds will be approved for sale after that date.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FDA withdraws 37 generic approvals
The FDA is withdrawing approval of 37 abbreviated new drug applications (ANDAs) as of November 9, 2026. This withdrawal covers the entire listed applications (including any strengths or dosage forms) and means the listed products may not be introduced into interstate commerce without an approved ANDA; doing so would violate 21 U.S.C. 355(a) and 331(d).
Existing inventory can still be dispensed
Drug products listed in the withdrawal table that are in inventory on November 9, 2026 may still be dispensed until the inventories have been depleted, the products reach their expiration dates, or they otherwise become violative, whichever occurs first. The applicants also waived their opportunity for a hearing, and withdrawal is without prejudice to refiling.
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