FDA to review RedHill's RHB-103 for migraines

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) said FDA accepted for review an NDA for RHB-103 to treat acute migraine. The PDUFA date is Feb. 3, 2014. The NDA was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. RedHill has exclusive, worldwide rights to co-develop and commercialize RHB-103 from IntelGenx Corp. (TSX-V:IGX; OTCBB:IGXT) under a 2010 deal. The product is a fast-dissolving thin-film formulation of rizatriptan delivered using IntelGenx's VersaFilm oral disintegrating film. ...