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FDA to review Levadex NDA

August 3, 2011 12:12 AM UTC

FDA accepted for review an NDA from Map Pharmaceuticals Inc. (NASDAQ:MAPP) for Levadex for the acute treatment of migraines. The PDUFA date is March 26, 2012. The acceptance triggers a $20 million payment to Map from Allergan Inc. (NYSE:AGN), which has U.S. co-promotion rights. The application 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. ...