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Makena Active Ingredient Compounding Ban Gets US FDA Panel Nod

 
• By Sue Sutter

The Pharmacy Compounding Advisory Committee unanimously voted to add hydroxyprogesterone caproate products for reducing the risk of recurrent singleton spontaneous preterm birth to the Withdrawn or Removed List under sections 503A and 503B of the Food, Drug and Cosmetic Act.

Sunset
The sun is quickly setting on compounding of HPC for preterm birth prevention. (Shutterstock)

Pharmacy compounding of hydroxyprogesterone caproate for prevention of preterm birth appears headed for a quiet ending in the US, a stark contrast to the controversy and debate that preceded withdrawal of the reference product, Covis Pharma’s Makena.

Key Takeaways
  • The Pharmacy Compounding Advisory Committee supported a ban on compounding hydroxyprogesterone caproate products for preterm birth prevention.
  • Several committee members said they...

On 29 October, the Food and Drug Administration’s Pharmacy Compounding Advisory Committee unanimously voted in favor of adding hydroxyprogesterone caproate (HPC) products for reducing the risk of recurrent singleton spontaneous...

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