Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications
Published Date: 1/15/2025
Notice
Summary
The FDA is officially pulling the plug on 12 drug approvals because the companies stopped selling these medicines. This change kicks in on February 14, 2025, and it mainly affects the drug makers and anyone tracking these products. Don’t worry—companies can ask to bring these drugs back if they want to in the future!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
FDA Withdraws 12 Drug Approvals
The FDA is withdrawing approval of 12 New Drug Applications (NDAs) as of February 14, 2025, because the applicants told FDA the products are no longer marketed and asked for withdrawal. The withdrawal applies to the entire listed applications (all strengths and forms) and is without prejudice to refiling if an applicant wants to seek approval again.
Selling These Drugs Without Approval Is Prohibited
After February 14, 2025, introducing or delivering for introduction into interstate commerce any of the listed products without an approved NDA will violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Companies, distributors, or others who move these products across state lines must ensure an approved NDA is in place.
Existing Inventory Can Still Be Dispensed
Drug products listed in the withdrawn NDAs that are in inventory on February 14, 2025, may continue to be dispensed until those inventories are depleted or the products reach their expiration dates, or otherwise become violative, whichever occurs first. This allows current stock to be used after the approval withdrawal date rather than being immediately unusable.
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Previous / Next Documents
Previous: 2025-00742, Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
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.
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