30 May 2025
🚫FDA Withdraws Approval of Two Drug Applications - Business Implications
Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two new drug applications (NDAs) from two 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 two new drug applications impacts businesses by potentially removing products from the market, which could affect sales and inventory management for companies like Meda AB and B. Braun Medical. The FDA's notice indicates compliance requirements for drug distribution, stressing that without an approved application, introducing these products into commerce would violate federal law.