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# Regulatory Review Period for Newron’s Xadago
- URL: https://www.fdaweb.com/regulatory-review-period-for-newrons-xadago/
- Published: 2019-02-12T12:00:00.000Z
- Updated: 2026-09-15T01:03:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143352

*Federal Register* notice: FDA has determined the regulatory review period for Newron Pharmaceuticals’ Xadago (safinamide mesylate), indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. The agency determined Xadago’s regulatory review period at 5,019 days, including 4,205 days that occurred during the testing phase and 814 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-12/pdf/2019-02044.pdf?ref=fdaweb.com).