Lupin Ltd Receives U.S. FDA Approval for Rivaroxaban Tablets

Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg. These tablets are bioequivalent to Xarelto® Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals. The product will be manufactured at Lupin’s Aurangabad facility in India. Rivaroxaban Tablets USP are indicated for reducing risk of stroke and systemic embolism in nonvalvular atrial fibrillation, treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction in the risk of recurrence of DVT and/or PE, prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery, prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding, treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years, and thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure. Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg (RLD Xarelto®) had estimated annual sales of USD 8,052 million in the U.S. (IQVIA MAT March 2025).