Safinamide Mesylate

For Parkinson's disease (PD) experiencing "off" episodes. Sold as Xadago. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 15, 2026, FDA lists 5 applications for Safinamide Mesylate (sold as Xadago), first approved Mar 21, 2017, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 21, 2017
Applications: 5
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $6.9M
First approved in the EU: Feb 23, 2015
First approved in Japan: Sep 20, 2019

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Xadago	Part D	$6.9M	-10%	662

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

XADAGO 100 MG TABLET: $36.33 per unitBrand · 0% in a year
XADAGO 50 MG TABLET: $36.46 per unitBrand · 0% in a year

Approvals in the EU (EMA)

First approved in the EU 25 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Xadago, new substanceZambon SpA · Feb 23, 2015

Approvals in Japan (PMDA)

First approved in Japan 30 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Equfina, new ingredientA drug with a new active ingredient indicated for the improvement of wearing-off phenomenon in patients with Parkinson’s disease under the treatment with… · Meiji Seika Pharma Co., Ltd. · Sep 20, 2019

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 21, 2017	XadagoNDA 207145 · New molecular entity	Mdd US	3	Marketed
Jun 14, 2023	Safinamide MesylateANDA 215902	Aurobindo Pharma	0	Discontinued
Apr 25, 2024	Safinamide MesylateANDA 215739	Prinston	0	Marketed
Dec 31, 2024	Safinamide MesylateANDA 215978	Msn	0	Marketed
Jun 13, 2025	Safinamide MesylateANDA 215913	Pharmazone	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA