Aurobindo Receives FDA Approval for Rivaroxaban Tablets USP, 2.5 mg
Published: April 10, 2025
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Rivaroxaban Tablets USP, 2.5 mg. Aurobindo Pharma’s Rivaroxaban Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xarelto Tablets manufactured by Janssen Pharmaceuticals, Inc. (Janssen).
Rivaroxaban Tablets are indicated:
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- For the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE
- For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.