FDA lays the fin­ish­ing touch­es on its plan to pull Mak­e­na

FDA is go­ing to be is­su­ing its fi­nal de­ci­sion soon on whether or not to pull the long­stand­ing ac­cel­er­at­ed ap­proval for Co­vis’ con­tro­ver­sial pre­na­tal drug Mak­e­na, while an­oth­er nail is dri­ven in­to the drug’s cof­fin.

CDER deputy di­rec­tor Celia Wit­ten wrote in a re­port sum­ma­ry on the FDA’s ad­comm meet­ing on Mak­e­na to FDA Com­mis­sion­er Robert Califf and chief sci­en­tist Na­mand­jé Bum­pus Fri­day that she does not be­lieve that Mak­e­na “has been shown to be ef­fec­tive,” ei­ther in the cur­rent pop­u­la­tion or a more lim­it­ed pop­u­la­tion for the drug that Co­vis pro­posed.

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