FDA Accepts NuPathe's Migraine Patch NDA Resubmission for Filing

NuPathe Inc.

, a biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that the company's New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the U.S. Food and Drug Administration (FDA). NuPathe has received a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of January 17, 2013. "As important as FDA acceptance of our NDA resubmission is for NuPathe, we believe it's even more significant for the millions of migraine patients who suffer from headache pain and debilitating migraine-related nausea," said Armando Anido, chief executive officer of NuPathe. "We look forward to working closely with the FDA to complete its review and to bringing our innovative new treatment option to migraine patients in 2013."