Strongbridge Biopharma (SBBP) Announces FDA Filing Acceptance of NDA for RECORLEV for Treatment of Endogenous Cushing’s Syndrome
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Strongbridge 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
May 13, 2021 7:30 AM EDT~ FDA Sets Prescription Drug User Fee Act (PDUFA) Target Action Date of January 1, 2022 ~
~ If Approved, RECORLEV® (levoketoconazole) Launch Planned for First Quarter of 2022 ~
DUBLIN, Ireland and TREVOSE, Pa., May 13, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Companys New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the treatment... More
