Makena Enforcement Discretion, Compounding Still In Limbo Post Long-Awaited Withdrawal

US FDA Commissioner and Chief Scientist call for immediate withdrawal of the preterm birth prevention drug and generic versions but defer to the Center for Drug Evaluation and Research on how to implement key lingering details.

pregnant person — Makena and its generics were withdrawn from the US market 5 April. • Source: Shutterstock

Preterm birth prevention drug Makena was officially pulled from the market 5 April, more than four years after the drug’s confirmatory trial required as a condition of accelerated approval failed. But thanks to a degree of deference by US Food and Drug Administration Commissioner Robert Califf and Chief Scientist Namandje Bumpus, Covis Pharma’s branded product and generic versions of the drug could linger on the market for a bit longer and compounding of the active ingredient may be possible longer-term.

Califf and Bumpus directed the Center for Drug Evaluation and Research to determine the next steps to implement their decision...