RedHill Biopharma Ltd. (RDHL) Announces FDA Acceptance for Review of RHB-103 NDA for Acute Migraine and PDUFA Goal Date of February 3, 2014
6/18/2013 8:59:24 AM
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TEL-AVIV, Israel, June 18, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, announced that the New Drug Application ("NDA") for marketing approval in the U.S. of RHB-103 of the Company and its co-development partner, IntelGenx Corp. ("IntelGenx"), has been accepted for substantive review by the U.S. Food and Drug Administration ("FDA"). RHB-103 is a proprietary, oral thin film formulation of rizatriptan, a leading drug for the treatment of acute migraine.
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