After 12 years on the market under an accelerated approval, the application holder for Makena has failed to provide sufficient efficacy data to the FDA to support continued marketing. The FDA said “[T]oday, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena.” The 26 page final decision (here) can be found with a little searching of the documents – look for the April 5th decision to withdrawal (took me about 10 minutes to find it on the link to regulations.gov above.). In its memo, FDA outlines its reasons for ultimate withdrawal.
The Agency notes that, because Makena and its generics now have their approvals withdrawn, firms may no longer legally distribute their product into interstate commerce. FDA recognizes that there may already be product distributed and says “[P]atients who have questions should talk to their healthcare provider. Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved.”
