RedHill Biopharma Ltd. Announces Successful Pre-NDA Meeting Wth FDA Toward a Filing of a U.S. New Drug Application (NDA) for its RHB-103 Anti-Migraine Oral Thin-Film
Published: Nov 09, 2012
TEL AVIV, Israel--(BUSINESS WIRE)--RedHill Biopharma Ltd. (TASE: RDHL), an Israeli biopharmaceutical company focusing primarily on development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, reported that on November 7th, the Company and its co-development partner, IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT), concluded a pre-New Drug Application ("pre-NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to RedHill's RHB-103, a patent protected, oral thin-film formulation of Rizatriptan (the active drug in Merck & Co.’s Maxalt-MLT® orally disintegrating tablets). RHB-103 is based on IntelGenx' proprietary immediate release "VersaFilm" oral thin-film technology for rapid dissolution.