Type:Notice
Citation:90 FR 3876
Reading Time:about a minute or two
The Food and Drug Administration (FDA) has decided to withdraw its approval of 23 abbreviated new drug applications (ANDAs) after being informed by the applicants that these drug products are no longer being marketed. This withdrawal is effective from February 14, 2025. The applicants have waived their right to a hearing regarding this decision. According to the regulations, any remaining inventory of these products can be dispensed until it runs out, expires, or otherwise becomes non-compliant.
Simple Explanation
The FDA is stopping the official approval of some medicines because the companies told them no one is selling these medicines anymore. They can still be used until they're gone or too old.