Xadago
Generic name: safinamide
Treatment for: Parkinson's Disease
Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA
Milan, Italy, March 2nd, 2015 - Newron Pharmaceuticals S.p.A. ("Newron"), 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 Admin-istration (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.
"The acceptance of the NDA submission for review is based on extensive inputs re-ceived from the FDA during the last six months. This decision indicates that the process of review of the comprehensive efficacy and safety data on Xadago can proceed expeditiously, and brings Xadago® closer to becoming available for patients in the U.S.," said Ravi Anand, M.D., Chief Medical Officer. "If approved by the FDA, Xadago will provide an innovative add-on treatment option for patients during all stages of Parkinson’s disease".
"We are in late stage negotiations with interested potential partners for Xadago in the U.S.", said Maurizio Castorina, Chief Executive Officer at Zambon. "And subject to FDA approval, Zambon expects the commercial launch of this New Chemical Entity by our North American partner in the first quarter of 2016".
The acceptance of the NDA by the FDA follows the Marketing Authorization by the EU Commission for Xadago for the treatment of Parkinson's disease in the EU, adopted on Feb. 24, 2015.
Source: Zambon S.p.A.
Posted: March 2015
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- US FDA Considers Newron’s Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter - October 21, 2016
- Newron Re-Submits US NDA for Xadago (safinamide) - September 22, 2016
- Newron to Re-Submit US NDA for Xadago (safinamide) - July 26, 2016
- Newron Receives Complete Response Letter from US FDA for Xadago (safinamide) - March 29, 2016
- Xadago (safinamide) NDA Late-Cycle Review Meeting Completed with U.S. FDA - September 30, 2015
- Safinamide NDA Re-Submitted to the U.S. FDA - December 29, 2014
- Refusal to File Letter Received from US FDA for Safinamide, Based on Organization and Navigation Problems - July 29, 2014
- Safinamide New Drug Application (NDA) Submitted to the U.S. Food and Drug Administration (FDA) - May 29, 2014
Xadago (safinamide) FDA Approval History
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