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# FDA Approves Expanded Xarelto Indication
- URL: https://www.fdaweb.com/fda-approves-expanded-xarelto-indication/
- Published: 2021-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:11:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149998

FDA has approved an expanded peripheral artery disease (PAD) indication for Janssen’s Xarelto (rivaroxaban) vascular dose to include patients following recent lower extremity revascularization (LER) due to symptomatic PAD. Janssen [says](https://www.marketwatch.com/press-release/fda-approves-expanded-peripheral-artery-disease-pad-indication-for-xarelto-rivaroxaban-plus-aspirin-to-include-patients-after-lower-extremity-revascularization-ler-due-to-symptomatic-pad-2021-08-24?tesla=y&ref=fdaweb.com) the approval is based on data from the Phase 3 VOYAGER PAD study.

With the approval, it says, Xarelto is the only therapy indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease and major thrombotic vascular events such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD.