Savaysa

Lowers the risk of stroke and systemic embolism (SE). NDA 206316, held by Daiichi Sankyo Inc. Edoxaban Tosylate.

As of Nov 14, 2026, NDA 206316 (Savaysa), held by Daiichi Sankyo Inc, was first approved by FDA on Jan 8, 2015, with 15 approved supplements and 0 published complete response letters.

First approved: Jan 8, 2015
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Oct 18, 2023	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Oct 18, 2023	Supplement 21Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 9, 2019	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 8, 2015	Original applicationEfficacy (new indication or use) · Standard review	Approved	None posted
Jan 8, 2015	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Letter

Products

3 strengths and forms


SavaysaEQ 15MG BASE · tablet;oral	Edoxaban Tosylate	RxReference drug
SavaysaEQ 30MG BASE · tablet;oral	Edoxaban Tosylate	RxReference drug
SavaysaEQ 60MG BASE · tablet;oral	Edoxaban Tosylate	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Oct 18, 2023	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Oct 18, 2023	Supplement 21Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 11, 2023	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 1, 2021	Supplement 18Labeling · Standard review	Approved	Letter
Apr 20, 2021	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 21, 2020	Supplement 16Labeling · Standard review	Approved	Label Letter
Aug 9, 2019	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2017	Supplement 12Labeling · Standard review	Approved	Letter Label
Sep 15, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
Apr 25, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 6, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 30, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 16, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 2Labeling · Standard review	Approved	Letter Label
Aug 24, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 8, 2015	Original applicationEfficacy (new indication or use) · Standard review	Approved	None posted
Jan 8, 2015	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Letter

Identifiers

Application: NDA 206316
Drugs@FDA: Overview at FDA
Company: Daiichi Sankyo

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters