FDA Waves Bye to 11 Dormant Drug Files
Published Date: 2/20/2026
Notice
Summary
The FDA is officially pulling the plug on 11 drug approvals because the companies stopped selling these medicines. This change affects Masuu Global Solutions LLC and Breckenridge Pharmaceutical, with the withdrawal taking effect on March 23, 2026. No money penalties here—companies just asked to close these files, but they can apply again if they want.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Existing Inventory May Still Be Dispensed
Drug products listed in the withdrawn ANDAs that are in inventory on March 23, 2026 may continue to be dispensed until those inventories are used up or the products reach their expiration dates. After that date, introducing those products into interstate commerce without an approved application would violate federal law.
FDA Withdraws 11 Generic Approvals
The FDA is withdrawing approval of 11 abbreviated new drug applications (ANDAs) as of March 23, 2026. Applicants informed the Agency that the products were no longer marketed and asked FDA to withdraw the approvals, including ANDAs filed by Masuu Global Solutions LLC and others listed in the notice.
Withdrawals Are Without Prejudice; Refiling Allowed
The notice says withdrawal of approval under 21 CFR 314.150(c) is without prejudice to refiling and that the applicants waived their opportunity for a hearing. Companies asked FDA to close these files and may reapply if they choose.
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