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Recorlev FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 6, 2022.

FDA Approved: Yes (First approved December 30, 2021)
Brand name: Recorlev
Generic name: levoketoconazole
Dosage form: Capsules
Company: Xeris Biopharma Holdings
Treatment for: Cushing's Syndrome

Recorlev (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome.

Development timeline for Recorlev

DateArticle
Dec 30, 2021Approval FDA Approves Recorlev (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome
May 13, 2021Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome
Mar  2, 2021Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the FDA

Further information

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