2022-19293: Proposal To Withdraw Approval of MAKENA; Hearing; Correction
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The Food and Drug Administration (FDA) is correcting a notice entitled "Proposal To Withdraw Approval of MAKENA; Hearing" that appeared in the Federal Register of August 17, 2022. The document announced the hearing on the Center for Drug Evaluation and Research's proposal to withdraw approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter, once weekly), new drug application 021945, held by Covis Pharma Group/Covis Pharma GmbH. The document was published with an incorrect deadline. This document corrects that error.
The agency’s own summary, as published.
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