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Makena: Professional Societies Finally See Eye To Eye With US FDA’s Drugs Center

 
• By Sue Sutter

After two decades of recommending use of intramuscular 17-OHPC to prevent preterm birth, the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine revised their clinical guidelines in the wake of the FDA’s order withdrawing Covis’ Makena and its generics.

Change in direction
ACOG and SMFM altered their clinical recommendations on Makena only after the FDA's withdrawal order came down. • Source: Shutterstock

For the first time in years, the US FDA’s Center for Drug Evaluation and Research and two professional societies are publicly aligned on the utility of Covis Pharma’s Makena (hydroxyprogesterone caproate) and its generics for prevention of preterm birth.

And it only took a drug withdrawal order from the agency to

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