US FDA Panel To Consider Compounding Ban For Makena’s Active Ingredient

Covis’ preterm birth prevention drug was withdrawn in April 2023. The agency now is considering whether hydroxyprogesterone caproate should be added to the list of products withdrawn or removed from the market after being found to be unsafe or not effective.

Hydroxyprogesterone caproate molecule
Hydroxyprogesterone caproate may be headed for a compounding ban. • Source: Shutterstock

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