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Makena: Formal Withdrawal Order Would Provide ‘Greater Certainty,’ Transparency – CDER

 
• By Sue Sutter

Final decision by the Office of Commissioner would provide more certainty than Covis’ proposal to voluntarily withdraw Makena ‘at some point in the future’ and assure that generic versions of the preterm birth prevention drug come off the market at the same time, the US FDA’s drugs center tells the Pink Sheet.

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CDER is seeking rock-solid assurance that Makena and its generics actually come off the market. • Source: Shutterstock

The US FDA’s Center for Drug Evaluation and Research rejected Covis Pharma’s proposal to voluntarily withdraw Makena (hydroxyprogesterone caproate injection) with a wind-down period because a final withdrawal order from the commissioner and chief scientist would provide “greater certainty,” transparency, as well as assurance that generic versions of the drug come off the market.

In response to questions from the Pink Sheet, the agency explained why it did not go along with Covis’ proposal, made shortly after the October 2022 public hearing under the accelerated approval regulations, to pull

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