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  • Aurobindo Pharma gets...

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 2025-04-14T11:30:58+05:30  |  Updated On 14 April 2025 11:30 AM IST
USFDA nod to generic therapeutic equivalent version of Janssen Pharma Haldol injection
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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.

The product will be launched in Q1FY26.

The approved product, Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of US$ 447 million for the twelve months ending February 2025, according to IQVIA. Aurobindo Pharma now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA.

Aurobindo Pharma also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is US$ 8.5 billion for the twelve months ending February 2025, according to IQVIA.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.
aurobindo pharmaaurobindo pharma newsUSFDArivaroxaban tabletsxareltojanssen pharmastrokenonvalvular atrial fibrillationdeep vein thrombosispulmonary embolism
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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