15 Jan 2025
🚫FDA Withdraws Approval of 23 Abbreviated New Drug Applications
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 withdrawal of FDA approval for 23 ANDAs indicates significant regulatory compliance implications for pharmaceutical companies. Businesses must ensure they do not market or sell these products post-withdrawal, affecting their operations and inventory management. Additionally, companies can potentially refile applications.