CDER asks FDA to re­voke Mak­e­na's ac­cel­er­at­ed ap­proval less than a week af­ter AM­AG ac­qui­si­tion

Just a few days af­ter an­nounc­ing it was be­ing ac­quired for near­ly $650 mil­lion, AM­AG Phar­ma­ceu­ti­cals $AM­AG re­ceived some sour news it’s like­ly been ex­pect­ing for a while.

CDER has for­mal­ly rec­om­mend­ed that the FDA re­voke the ac­cel­er­at­ed ap­proval for AM­AG’s flag­ship drug, Mak­e­na. The med­i­cine, de­vel­oped to re­duce the risk of preterm birth in women who had pre­vi­ous­ly ex­pe­ri­enced one, failed to show a clin­i­cal ben­e­fit in its post-ap­proval con­fir­ma­to­ry tri­al, CDER said in a state­ment.

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