24 Sep 2025
❌FDA Withdraws Approval of 72 Drug Applications - Business Impact
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 72 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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
$$$ - High
The FDA's withdrawal of approval for 72 ANDAs directly impacts businesses involved in the manufacturing and distribution of the affected drugs. Companies must adjust their product lines and inventory strategies to comply with this regulatory change, potentially leading to financial losses or the need for new approvals.