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Makena Active Ingredient Compounding Ban Would Be Limited To Preterm Birth Prevention

 
• By Sue Sutter

The proposed ban would not affect compounding hydroxyprogesterone caproate for various gynecological indications which remain the subject of approved, albeit discontinued, new and generic drug applications, the US FDA said in an advisory committee briefing document.

Mortar and pestle
The FDA is proposing to prohibit compounding of Makena's active ingredient for preventing preterm birth. (Shutterstock)

The US Food and Drug Administration proposed banning the compounding of all drug products containing hydroxyprogesterone caproate, the active ingredient in Covis’ Makena, to reduce the risk of singleton spontaneous preterm birth.

Key Takeaways
  • The FDA proposed adding hydroxyprogesterone caproate products for reducing the risk of recurrent singleton spontaneous preterm birth to the Withdrawn or Removed List under sections...

The proposed ban would not affect the ability to compound hydroxyprogesterone caproate for various gynecological indications, the FDA said in a briefing document for a...

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