4 Aug 2025
💊FDA Withdraws Approval of 39 New Drug Applications
Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 39 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The withdrawal of approval for 39 drug products may impact manufacturers and associated businesses, necessitating compliance with new market restrictions and inventory management. The FDA’s prohibition on distribution without approval emphasizes regulatory obligations for affected entities.