'False hopes': FDA re­leas­es brief­ing docs on con­tro­ver­sial preterm birth med Mak­e­na ahead of ad­comm

The FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) dropped its brief­ing doc­u­ments spelling out why Co­vis’ con­tro­ver­sial preterm birth drug Mak­e­na should be pulled from the mar­ket — and it isn’t minc­ing words.

Ahead of an ad­vi­so­ry com­mit­tee meet­ing sched­uled for Oct. 17-19, CDER re­leased an 86-page brief­ing on Mak­e­na, which was ap­proved in 2011 through the FDA’s ac­cel­er­at­ed ap­proval path­way.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.