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# FDA Approves a Jannsen sNDA for Xarelto
- URL: https://www.fdaweb.com/fda-approves-a-jannsen-snda-for-xarelto/
- Published: 2017-10-30T12:00:00.000Z
- Updated: 2026-09-14T22:58:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139999

FDA has approved a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. The approval is based on data from the EINSTEIN CHOICE clinical study that showed patients taking Xarelto at this 10mg dose had significantly fewer recurrent VTE compared to those taking aspirin.