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

Executive Summary

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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