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, 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)|
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