Aurobindo Pharma gets USFDA final, tentative nod for different strengths of deep vein thrombosis drug Rivaroxaban
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-04-14 06:00 GMT | Update On 2025-04-14 06:00 GMT
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Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market RivaroxabanTablets USP, 2.5 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc.
Rivaroxaban Tablet USP is used (i) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (ii) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE (iii) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
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