14 Mar 2025
💊FDA Withdraws Approval of Abbreviated New Drug Applications
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Four Abbreviated New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 approval for four ANDAs signifies regulatory compliance mandates for businesses that market these drug products. Companies must cease distribution unless they have updated approvals, which impacts inventory and market options. This demonstrates a shift in the pharmaceutical landscape that may require business adaptations.