FDA Decision on Recorlev for Endogenous Cushing’s Expected Early 2022

FDA Decision on Recorlev for Endogenous Cushing’s Expected Early 2022

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FDA Decision on Recorlev for Endogenous Cushing’s Expected Early 2022

The U.S. Food and Drug Administration (FDA) is reviewing an application from Strongbridge Biopharma seeking the approval of Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome. A final decision from the FDA is expected by Jan. 1, 2022 — meaning that Recorlev’s approval request will follow the standard 10-month review period. Strongbridge was notified of the action target date in an official letter from the U.S. regulatory agency, which was issued earlier than expected.…

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