Newron Pharmaceuticals S.p.A., a research and development company focused on novel central nervous system (CNS) and pain therapies, and its commercial and development partner, Zambon S.p.A., an international pharmaceutical company, announced today that the New Drug Application (NDA) for Xadago (safinamide) has been accepted for filing by the U.S. Food and Drug Administration (FDA).

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of December 29, 2015 to complete its review of the NDA.

The application covers the proposed use of Xadago (safinamide) as add-on therapy in both early and mid-to-late stage Parkinson’s disease patients who are inadequately managed on their current treatment.

For more details, go to: http://www.newron.com/en