Xadago FDA 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 timeline for Xadago
Date | Article |
---|
Mar 21, 2017 | Approval FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease |
Oct 21, 2016 | US FDA Considers Newron’s Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter |
Sep 22, 2016 | Newron Re-Submits US NDA for Xadago (safinamide) |
Jul 26, 2016 | Newron to Re-Submit US NDA for Xadago (safinamide) |
Mar 29, 2016 | Newron Receives Complete Response Letter from US FDA for Xadago (safinamide) |
Sep 30, 2015 | Xadago (safinamide) NDA Late-Cycle Review Meeting Completed with U.S. FDA |
Mar 2, 2015 | Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA |
Dec 29, 2014 | Safinamide NDA Re-Submitted to the U.S. FDA |
Jul 29, 2014 | Refusal to File Letter Received from US FDA for Safinamide, Based on Organization and Navigation Problems |
May 29, 2014 | Safinamide New Drug Application (NDA) Submitted to the U.S. Food and Drug Administration (FDA) |
Further information
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