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Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial

Executive Summary

Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.

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Makena Will Get Extended Time On Market, Even If AMAG’s Appeal Fails

AMAG’s decision to fight US FDA’s decision to pull the preterm birth product seems unlikely to result in victory, but Makena will get to stay on the market during the appeal process, which is expected to be protracted and will likely include accusations that the agency is being insensitive to affected patients.

End Of The Line For Makena?

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.

US FDA Tried, But Failed, To Take Compounding Issue Off The Table At Makena AdComm

Clinicians and patients would look for 17P wherever they could find it if AMAG’s FDA-approved formulation of the preterm birth drug comes off the market, panelists said; Cowen analysts believe the potential for safety concerns posed by compounded formulations will save Makena from the regulatory chopping block.

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