Global pharma major Lupin Limited (Lupin) 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 for Oral Suspension, 1 mg/mL which is bioequivalent to Xarelto for Oral Suspension, 1 mg/mL of Janssen Pharmaceuticals. The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India.

Rivaroxaban for Oral Suspension is indicated for:

• Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.

• Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto) had estimated annual sales of US$ 11 million in the U.S. (IQVIA MAT July 2025).