Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals

Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals

Source: 
RAPS.org
snippet: 

Earlier this week, an FDA advisory committee recommended that the agency withdraw Amag Pharmaceutical’s preterm birth drug Makena, a treatment that brought in more than $1 billion in sales before failing a confirmatory trial.

The agency is now faced with the task of whether to take the committee’s vote and pull Makena from the market or allow it to remain until another confirmatory trial can be completed. Keeping Makena on the market would also present a rare situation, as according to a recent study, the agency makes a decision that runs counter to its advisory committees only about one in five times.