Last Updated on April 23, 2025 by The Health Master
USFDA approval
Hyderabad, India – In a significant stride towards expanding its presence in the United States pharmaceutical market, Aurobindo Pharma, a globally integrated pharmaceutical powerhouse headquartered in Hyderabad, India, announced today that it has secured final U.S. Food and Drug Administration approval (USFDA approval) to manufacture and distribute its Rivaroxaban Tablets USP, 2.5 mg.,
This crucial approval paves the way for the immediate commercialization of this generic version of a widely used anticoagulant.
Generic Alternative
The newly USFDA approval Rivaroxaban Tablets USP, 2.5 mg, developed by Aurobindo Pharma, has been confirmed by the USFDA to be bioequivalent and therapeutically equivalent to Janssen Pharmaceuticals Inc.’s reference listed drug (RLD), XARELTO, 2.5 mg.
This equivalence ensures that patients can now access a more affordable alternative without compromising on efficacy or safety.
Therapeutic Applications
Rivaroxaban is a vital medication prescribed for various critical conditions, including:
- Reducing the risk of stroke and systemic embolism in individuals diagnosed with nonvalvular atrial fibrillation, a common heart rhythm disorder.
- Treatment of deep vein thrombosis (DVT), a serious condition involving blood clots in deep veins, typically in the legs.
- Treatment of pulmonary embolism (PE), a potentially life-threatening condition where blood clots travel to the lungs.
- Lowering the risk of recurrence of both DVT and PE, providing long-term protection for individuals who have previously experienced these events.
- Prophylaxis of DVT, which can subsequently lead to PE, in patients undergoing major orthopedic surgeries such as knee or hip replacement.
USFDA Approvals
With this latest USFDA approval, Aurobindo Pharma now boasts a total of 540 ANDA (Abbreviated New Drug Application) approvals from the USFDA, comprising 521 final approvals and 19 tentative approvals.
This robust portfolio underscores the company’s strong research and development capabilities and its commitment to serving the US market with high-quality generic medications.
Tentative Approval for Higher Strengths Signals Future Growth
In addition to the final approval for the 2.5 mg strength, Aurobindo Pharma also announced that it has received tentative approval from the USFDA for the 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP.
The combined estimated market size for all strengths of Rivaroxaban tablets USP in the US is a massive $8.5 billion for the twelve months ending February 2025, as per IQVIA data.
These tentative approvals indicate a promising future for Aurobindo Pharma in this therapeutic area, pending final USFDA clearances.
Q. What is Rivaroxaban used for?
Rivaroxaban is used to prevent and treat blood clots, reducing the risk of stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE). It is also used to prevent DVT in patients undergoing knee or hip replacement surgery.
Q. What does USFDA final approval mean?
A. Final approval from the USFDA means that Aurobindo Pharma has met all the necessary requirements and can now legally manufacture and market its Rivaroxaban Tablets USP, 2.5 mg, in the United States.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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