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Xadago Approval History

FDA Approved: Yes (First approved March 21, 2017)
Brand name: Xadago
Generic name: safinamide
Dosage form: Tablets
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Development History and FDA Approval Process for Xadago

Mar 21, 2017Approval FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease
Oct 21, 2016US FDA Considers Newron’s Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter
Sep 22, 2016Newron Re-Submits US NDA for Xadago (safinamide)
Jul 26, 2016Newron to Re-Submit US NDA for Xadago (safinamide)
Mar 29, 2016Newron Receives Complete Response Letter from US FDA for Xadago (safinamide)
Sep 30, 2015Xadago (safinamide) NDA Late-Cycle Review Meeting Completed with U.S. FDA
Mar  2, 2015Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA
Dec 29, 2014Safinamide NDA Re-Submitted to the U.S. FDA
Jul 29, 2014Refusal to File Letter Received from US FDA for Safinamide, Based on Organization and Navigation Problems
May 29, 2014Safinamide New Drug Application (NDA) Submitted to the U.S. Food and Drug Administration (FDA)
Nov 14, 2012Newron Provides Update on Submission Plans for Safinamide
Oct 21, 2011Newron Regains Full Global Rights to Safinamide from Merck Serono
Nov  4, 2010Merck KGaA: Top-Line Results of Long-Term Study of Safinamide as Add-On Treatment to Levodopa in Advanced Parkinson's Disease
Feb  3, 2009Merck’s Safinamide Significantly Improved Motor Function in Patients with Advanced Parkinson’s Disease in a Phase III Pivotal Trial
Aug 22, 2007Merck Serono Announces 18-Month Safety and Efficacy Data of Phase III Trial of Safinamide in Parkinson's Disease
Jun  8, 2007Promising Data on Cognitive Effects of Safinamide in Early Parkinson's Disease
May  2, 2007Phase III Data on Safinamide in Parkinson’s Disease Presented at American Academy of Neurology 59th Annual Meeting
Apr 27, 2007Merck Serono Announces Presentation of Phase III Clinical Data on Safinamide in Parkinson’s Disease at the American Academy of Neurology 59th Annual Meeting

Further information

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