14 Mar 2025
💊FDA Withdraws Approval of Eight Drug Applications
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 drug application approvals indicates compliance and regulatory implications for businesses in the pharmaceutical sector. Businesses must ensure adherence to the regulations regarding drug approvals and inventory management, as any violations can lead to legal consequences.