Regulatory Affairs

FDA accepts NuPathe migraine patch NDA resubmission

PBR Staff Writer Published 02 August 2012

US based NuPathe announced that its New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the US Food and Drug Administration (FDA).

Migraine Patch (NP101 or Zelrix) is an active, single-use, transdermal patch in the development process to treat migraine.

NuPathe has received a Prescription Drug User Fee Act (PDUFA) date and the target date for the FDA to complete its review of the NDA is 17 January 2013.

NuPathe CEO Armando Anido said FDA acceptance of the company's NP101NDA resubmission is a significant achievement for the migraine patients who suffer from headache pain and debilitating migraine-related nausea.

"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,"Anido added.