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One More Message From Makena: Fighting US FDA Can Pay Off

 
• By Michael McCaughan

The US FDA process to force the withdrawal of the pre-term labor drug Makena is in its final stages. The product seems likely to finally leave the market – but may also demonstrate that there is a business to be built in contesting FDA withdrawal proceedings.

makena hearing cash register
• Source: Shutterstock

The Makena withdrawal process will provide many lessons for sponsors and regulators alike as efforts continue to optimize the US Food & Drug Administration’s Accelerated Approval pathway.

The lopsided vote by FDA’s Obstetrics, Reproductive & Urologic Drugs Advisory Committee to support withdrawal of the pre-term labor drug hydroxyprogesterone all but guarantees the

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