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Lupin receives tentative approval from FDA for rivaroxaban tablets

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BALTIMORE Lupin announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Rivaroxaban Tablets USP are 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 revascularization due to symptomatic PAD
  • for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years
  • for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure

Rivaroxaban Tablets USP (RLD Xarelto®) had estimated annual sales of USD 8,249 million in the U.S. (IQVIA MAT November 2023).


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