Lupin Gets USFDA Nod For Rivaroxaban Tablets

Lupin Ltd. on Thursday said it has received approval from the US Food and Drug Administration for its abbreviated new drug application for rivaroxaban tablets in 10 mg, 15 mg, and 20 mg strengths. The drug is a generic version of Janssen Pharmaceuticals’s

Xarelto tablets and will be manufactured at Lupin’s Aurangabad facility in Maharashtra, the company said in an exchange filing.

Rivaroxaban is used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and for prophylaxis of venous thromboembolism in hospitalised patients at risk but not at high risk of bleeding. It is also used for thromboprophylaxis in children aged two and above with congenital heart disease after the Fontan procedure, the company said.

Quoting IQVIA data, Lupin said the estimated annual sales of rivaroxaban tablets in the US were around $8.05 billion for the year ended March.