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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

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)

Further information

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