6 November 2020 - The US FDA is seeking to withdraw the approval of the only drug indicated to prevent recurrent preterm birth, based on a post-approval study showing a lack of efficacy.

Makena (hydroxyprogesterone caproate) was originally granted accelerated approval in 2001 and remains on the market. 

Makena’s manufacturer, AMAG Pharmaceuticals, has requested a public hearing to explore the issue. 

Read Regulatory Affairs Professional Society article