More than a decade af­ter its ac­cel­er­at­ed ap­proval, vot­ing ques­tions set for pre­ma­ture birth drug's with­draw­al hear­ing

First ap­proved in 2011 un­der the ac­cel­er­at­ed ap­proval path­way to re­duce the risk of pre­ma­ture births, Co­vis Phar­ma’s Mak­e­na flunked its con­fir­ma­to­ry study, fail­ing to show the drug works, but still the com­pa­ny has re­fused to pull it from the mar­ket.

Since Oct. 5, 2020, when CDER first pro­posed with­draw­ing the ac­cel­er­at­ed ap­proval of Mak­e­na, Co­vis has been pro­vid­ing ad­di­tion­al in­fo and ex­chang­ing legalese with the FDA at mul­ti­ple turns on how this with­draw­al hear­ing should pro­ceed.

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