Lupin 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.
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. It is also used for the 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 USD 11 million in the US.