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US FDA Tried, But Failed, To Take Compounding Issue Off The Table At Makena AdComm

 
• By Sue Sutter

Clinicians and patients would look for 17P wherever they could find it if AMAG’s FDA-approved formulation of the preterm birth drug comes off the market, panelists said; Cowen analysts believe the potential for safety concerns posed by compounded formulations will save Makena from the regulatory chopping block.

Mortar
Withdrawal of Makena will drive clinicians and patients to seek out compounded versions of 17P, panelists said. • Source: Shutterstock

Seemingly everyone wanted to discuss the issue of compounding at the recent US Food and Drug Administration advisory committee meeting on the future of AMAG Pharmaceuticals Inc.'s preterm birth drug Makena.

Everyone, that is, except

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