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

 
• By Sue Sutter

Covis’ preterm birth prevention drug was withdrawn in April 2023. The agency now is considering whether hydroxyprogesterone caproate should be added to the list of products withdrawn or removed from the market after being found to be unsafe or not effective.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

More than a year-and-a-half after the US Food and Drug Administration withdrew accelerated approval of Covis Pharma’s preterm birth prevention drug Makena, an advisory committee will consider prohibiting compounding its active ingredient.

Key Takeaways

  • The FDA’s Pharmacy Compounding Advisory Committee will weigh whether compounding hydroxyprogesterone caproate for the prevention of preterm birth should be prohibited.

  • The adcomm marks the separate process that top FDA officials said was necessary to handle the compounding issue when they ordered the withdrawal of Makena

The Pharmacy Compounding Advisory Committee will meet 29 October to discuss whether to add certain drug products containing hydroxyprogesterone caproate to the list of those withdrawn or removed from the market because they were found to be unsafe or not effective

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