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)

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