​​FDA withdraws approval of preterm prevention drug Makena®

May 5, 2023

​On April 6, 2023, the FDA withdrew the approval and distribution of the drug Makena® (hydroxyprogesterone caproate) and its generics. Effective immediately, AmeriHealth HMO, Inc. and AmeriHealth Insurance Company of New Jersey will not accept new authorizations for Makena.

Makena was approved by the FDA under the accelerated approval pathway in 2011. The product was manufactured to prevent premature (preterm) birth in parents who experienced preterm birth in earlier pregnancies.

The FDA based its decision on the manufacturer demonstrating an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. The agency's approval, however, also included a requirement that the manufacturer conduct a post-marketing confirmatory study. The ensuing confirmatory study did not verify clinical benefit.

How does this affect our members?

Current members on Makena should consult directly with their treating health care provider about their treatment options given the Makena's removal from the market.

Medical Policy update

The Medical Policy for Makena will be archived, and the policy position will be Not Medically Necessary based on the information from the FDA.

For more information

For more information on this decision, the complete statement on the U.S. market withdrawal of Makena can be found on the FDA website.​