Lupin Receives Approval from U.S. FDA for Rivaroxaban for Oral Suspension

Global pharma major Lupin Limited has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL. The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India. Rivaroxaban for Oral Suspension is indicated for the 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. It is also indicated for 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 USD 11 million in the U.S. (IQVIA MAT July 2025).