RHB 103 (RedHill Biopharma) filed at FDA for treatment of acute Migraine

RedHill Biopharma Ltd. an emerging Israeli biopharmaceutical company has 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.has been accepted for substantive review by the FDA.

The 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.