Mak­e­na's ac­cel­er­at­ed ap­proval with­draw­al hear­ing set for Oc­to­ber as Co­vis wants to do more re­search

The long-await­ed FDA hear­ing to re­view Co­vis Phar­ma’s ac­cel­er­at­ed ap­proval for its con­tro­ver­sial preterm birth in­jec­tion, which failed its con­fir­ma­to­ry tri­al, will take place from Oct. 17-19.

The FDA’s Ob­stet­rics, Re­pro­duc­tive and Uro­log­ic Drugs Ad­vi­so­ry Com­mit­tee will con­duct the hear­ing about the fu­ture of Mak­e­na (hy­drox­yprog­es­terone caproate in­jec­tion), the com­pa­ny said in a state­ment yes­ter­day.

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