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End Of The Line For Makena?

 
• By Sue Sutter

Pink Sheet infographic shows the many regulatory challenges and sponsors that the preterm birth prevention drug has endured leading up to the US FDA's proposal for market withdrawal.

The 5 October announcement that the US Food and Drug Administration's Center for Drug Evaluation and Research is proposing to withdraw the accelerated approval of AMAG Pharmaceuticals Inc.'s Makena (hydroxyprogesterone caproate) for preterm birth prevention caps a troubled 21-year history filled with regulatory complications, clinical trial challenges and multiple changes in sponsorship. (Also see "Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial" - Pink Sheet, 6 October, 2020.)

Graphic design by Jean Smith

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