Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October

 
• By Sue Sutter

Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.

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Whether Makena should continue to be marketed for preventing preterm birth is the focus of an October AdComm. • Source: Shutterstock

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