5 October 2020 - Today, the U.S. FDA’s Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required post-market study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.

Makena received accelerated approval in 2011 to reduce the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth, which is delivery of a baby before 37 weeks.

Read FDA press release