Xarelto

Lowers the risk of stroke and systemic embolism in nonvalvular atrial fibrillation. NDA 22406, held by Janssen Pharms. Rivaroxaban.

As of Nov 14, 2026, NDA 22406 (Xarelto), held by Janssen Pharms, was first approved by FDA on Jul 1, 2011, with 34 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2011
Review: Standard
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation for treatment of deep vein thrombosis (DVT) for treatment of pulmonary embolism (PE) for reduction in the risk of recurrence of DVT or PE for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity re…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below


Oct 11, 2019	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 27, 2017	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 1, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 2, 2012	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 2, 2012	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 2, 2012	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 1, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Xarelto10MG · tablet;oral	Rivaroxaban	RxReference drug
Xarelto15MG · tablet;oral	Rivaroxaban	RxReference drug
Xarelto20MG · tablet;oral	Rivaroxaban	RxReference drug
Xarelto2.5MG · tablet;oral	Rivaroxaban	RxReference drug

All 35 submissions, including labeling and manufacturing supplements


Mar 24, 2026	Supplement 45Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 17, 2025	Supplement 44Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 8, 2023	Supplement 41Labeling · Standard review	Approved	Letter Label
Mar 1, 2022	Supplement 39Labeling · Standard review	Approved	Letter Label
Aug 23, 2021	Supplement 37Labeling · Standard review	Approved	Letter Label
Jan 28, 2021	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 10, 2020	Supplement 35Labeling · Standard review	Approved	Letter Label
Nov 15, 2019	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 11, 2019	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 23, 2019	Supplement 34Labeling · Standard review	Approved	Label Letter
Jan 15, 2019	Supplement 32Labeling · Standard review	Approved	Letter Label
Jan 15, 2019	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 7, 2018	Supplement 29Labeling · Standard review	Approved	Letter Label
Jul 30, 2018	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 27, 2017	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 28, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Feb 10, 2017	Supplement 21Labeling · Standard review	Approved	None posted
Aug 25, 2016	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 25, 2016	Supplement 19Labeling · Standard review	Approved	Letter Label
Aug 17, 2016	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 26, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
May 5, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 16, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 15, 2015	Supplement 12Labeling · Standard review	Approved	Letter Label
Dec 19, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Sep 15, 2014	Supplement 11Manufacturing · Standard review	Approved	Label
Mar 6, 2014	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 13, 2014	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 7, 2014	Supplement 7Labeling · Standard review	Approved	Label Letter
Mar 1, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 31, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 2, 2012	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 2, 2012	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 2, 2012	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 1, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 22406
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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