FDA Calls for Market Withdrawal of Makena, Generics

October 7, 2020

The FDA is calling for AMAG Pharmaceuticals to withdraw its preterm birth injection Makena (hydroxyprogesterone caproate), as well as its generics, from the market after a postmarket study failed to demonstrate efficacy.

The move comes a year after an FDA advisory committee voted to revoke approval of the drug.  Nine members of the expert panel sought immediate withdrawal of approval, while seven voted to keep Makena on the market but mandated a new clinical trial.

Makena is the only FDA-approved drug for the prevention of preterm birth in women who are pregnant but have a history of preterm births. In 2011, the FDA granted the drug accelerated approval with the caveat that a confirmatory trial was required to verify clinical benefit.

However, results announced in March 2019 failed to show a statistically significant difference between the drug vs. placebo or that the treatment reduced rates of fetal and neonatal health problems or death.

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