4 Aug 2025
💊FDA Notice on Withdrawal of Abbreviated New Drug Applications
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
Summary
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice involves the withdrawal of 23 ANDA approvals, which has direct regulatory implications for businesses involved in drug manufacturing and distribution, potentially impacting revenue and market access.