FDA fi­nal­ly de­cides to pull preterm birth drug Mak­e­na — ef­fec­tive im­me­di­ate­ly

The FDA on Thurs­day told Co­vis Phar­ma to im­me­di­ate­ly pull its preterm birth drug Mak­e­na, which first won ac­cel­er­at­ed ap­proval in 2011 but failed its con­fir­ma­to­ry tri­al, and re­cent­ly saw an FDA ad­comm vote 14-1 to pull the drug.

Lux­em­bourg-based Co­vis, which said in March it was will­ing to pull the drug fol­low­ing the ad­comm flop, had sought a wind-down pe­ri­od for its drug.

“Ef­fec­tive to­day, Mak­e­na and its gener­ics are no longer ap­proved and can­not law­ful­ly be dis­trib­uted in in­ter­state com­merce,” FDA said Thurs­day.

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