FDA lawyer digs in her heels as Mak­e­na ac­cel­er­at­ed ap­proval with­draw­al saga drags on

It’s been al­most 18 months since the FDA rec­om­mend­ed that Co­vis Phar­ma with­draw its con­tro­ver­sial preterm birth drug Mak­e­na, and still the drug, which first won an ac­cel­er­at­ed ap­proval in 2011 but failed a con­fir­ma­to­ry tri­al in 2018, re­mains on the mar­ket.

The on­go­ing saga, which will like­ly cul­mi­nate in a Co­vis-re­quest­ed hear­ing at an un­known date, re­veals how long a com­pa­ny can keep so-called “dan­gling” ac­cel­er­at­ed ap­provals on the mar­ket, even as the FDA has made clear mul­ti­ple times that the con­fir­ma­to­ry tri­al showed “no ef­fi­ca­cy on neona­tal out­comes,” which was the pri­ma­ry end­point.

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