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Xadago Approval Status

  • FDA approved: No
  • Brand name: Xadago
  • Generic name: safinamide
  • Company: Newron Pharmaceuticals S.p.A.
  • Treatment for: Parkinson's Disease

Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.

Development Status and FDA Approval Process for Xadago

DateArticle
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

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