The US Food and Drug Administration and Covis Pharma are navigating uncharted waters with the agency-ordered withdrawal of preterm birth prevention drug Makena (hydroxyprogesterone caproate) for lack of demonstrated efficacy.
Accelerated Approval: US FDA, Covis Navigate Novel Issues With Makena’s Withdrawal
Ahead of the final withdrawal decision, FDA terminated internal separation of functions so that the Office of the Commissioner and CDER could coordinate next steps; Makena’s NDA approval has been withdrawn, but the product’s website lives on, albeit with a pop-up window explaining the regulatory action.
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