Type:Notice
Citation:90 FR 3877
Reading Time:about a minute or two
The FDA is withdrawing approval for 12 new drug applications (NDAs) because the drugs are no longer being sold, and the companies that own them have requested this action. The approval withdrawal, effective February 14, 2025, affects all parts of the applications, including any dosage forms or strengths. Any remaining stock of these drugs can be sold until it is gone or expires.
Simple Explanation
The FDA is taking back its approval for 12 medicines because they aren't being sold anymore, and the companies that own them asked for this. People can still sell or use any leftover stock of these medicines until it's all gone or gets too old.