Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Published Date: 1/15/2025
Notice
Summary
The FDA is officially pulling the plug on 23 drug approvals because the companies told them these medicines aren’t being sold anymore. This change affects several drug makers, including Teva and Sandoz, and takes effect on February 14, 2025. No money penalties here—companies just asked to close these files, but they can always apply again if they want.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Approval withdrawn for 23 ANDAs
The FDA is withdrawing approval of 23 abbreviated new drug applications (ANDAs) as of February 14, 2025. The notice names multiple applicants (for example, Teva and Sandoz) and says approval of each entire application is withdrawn, including any strengths or dosage forms; introducing those products into interstate commerce without an approved new drug application or ANDA would violate the Federal Food, Drug, and Cosmetic Act (sections 505(a) and 301(d)).
Existing inventory may still be dispensed
Drug products listed in the notice that are in inventory on February 14, 2025 may continue to be dispensed until those inventories are depleted, the products reach their expiration dates, or they otherwise become violative, whichever occurs first. This provides a temporary continuation of access from existing stock after approval is withdrawn.
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