Lupin Receives Tentative Approval from US FDA for Rivaroxaban Tablets

Lupin Limited has received tentative approval from the US FDA for its Abbreviated New Drug Application for Rivaroxaban Tablets to market a generic equivalent of Xarelto® Tablets. This product will be manufactured at Lupin's Pithampur facility in India and is indicated for several conditions, including reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, treating deep vein thrombosis and pulmonary embolism, and reducing the risk of recurrence of DVT or PE. The product had estimated annual sales of USD 8,249 million in the US (l1QVIA MAT November 2023).,