15 Jan 2025
💊FDA Withdraws Approval of 12 Drug Applications
Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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
$$ - Med
The FDA's withdrawal of approval for 12 NDAs indicates a regulatory change impacting pharmaceutical companies and their product lines. Businesses may face compliance challenges and potential impacts on inventory management due to the cessation of marketing these drugs. Additionally, companies may need to reassess their future product strategies or refiling options.