Ahead of ac­cel­er­at­ed ap­proval with­draw­al hear­ing, Co­vis asks FDA to omit study po­ten­tial­ly link­ing Mak­e­na and can­cer

It’s been al­most 10 months since the FDA grant­ed Co­vis Phar­ma a hear­ing to re­view its con­tro­ver­sial preterm birth drug Mak­e­na, which won an ac­cel­er­at­ed ap­proval but failed its con­fir­ma­to­ry tri­al, and still the com­pa­ny and FDA are wran­gling over the de­tails of that hear­ing.

In a let­ter dat­ed Thurs­day, Co­vis lawyers from Si­d­ley are now ob­ject­ing to the hear­ing, in­clud­ing a pub­li­ca­tion that sug­gests a po­ten­tial link be­tween Mak­e­na and can­cer in the off­spring.

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