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The RHB-103 New Drug Application (NDA) for marketing approval in the U.S. is subject to a standard 10-month review period and will have a Prescription Drug User Fee Act (PDUFA) action date (targeted date for completion of FDA review) of February 3, 2014
The Company recently received from FDA a PDUFA fee waiver and a subsequent refund of $979,400
RHB-103 is a proprietary, oral thin film formulation of rizatriptan, a leading drug for the treatment of acute migraine
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.
The acceptance of the NDA for review reflects FDA's determination that the application is sufficiently complete to permit a substantive review of RedHill's RHB-103 marketing application. FDA indicated that the NDA is subject to a standard 10-month review period and will have a Prescription Drug User Fee Act ("PDUFA") goal date of February 3, 2014. The PDUFA action goal date is the targeted date for FDA to complete its review of the NDA.
The Company has recently been granted a waiver of the PDUFA fee under the small business waiver provision of the Federal Food, Drug and Cosmetic Act and subsequently has received from FDA a refund in the amount of $979,400, which represents the PDUFA fee previously paid by the Company.