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Lowers the risk of stroke and systemic embolism (SE). Sold as Savaysa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Edoxaban Tosylate (sold as Savaysa), first approved Jan 8, 2015, with 3 new uses approved and 0 published complete response letters.
First approved: Jan 8, 2015
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $4.9M
First approved in the EU: Jun 19, 2015
First approved in Japan: Apr 22, 2011
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Savaysa
Part D
$4.9M
-4%
1,392
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
SAVAYSA 30 MG TABLET: $15.48 per unitBrand · +5% in a year
SAVAYSA 60 MG TABLET: $15.51 per unitBrand · +6% in a year
Approvals in the EU (EMA)
First approved in the EU 5 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 45 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
LixianaDrugs with a new indication for the prevention of thrombus/embolus formation in patients with chronic thromboembolic pulmonary hypertension. · Daiichi Sankyo Company, Limited · Feb 20, 2025
LixianaDrugs with a new dosage indicated for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation. · Daiichi Sankyo Company, Limited · Aug 25, 2021
LixianaDrugs with new additional indications and new dosages, and a drug with a newly-added dosage form indicated for prevention of ischemic stroke and systemic… · Daiichi Sankyo Company, Limited · Sep 26, 2014
Lixiana, new ingredientDrugs with a new active ingredient indicated for prevention of venous thromboembolism in patients undergoing orthopedic surgery of lower limbs including… · Daiichi Sankyo Company, Limited · Apr 22, 2011 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
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
