9 Apr 2025
🚫FDA Withdraws Approval for 18 New Drug Applications
GE HealthCare, et al.; Withdrawal of Approval of 18 New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 18 NDAs impacts pharmaceutical companies and business owners by influencing their market strategies, inventory management, and potential financial liabilities. Companies must comply with the regulation to avoid marketing unapproved drugs.