Lupin receives tentative US FDA approval for Apixaban Tablets, 2.5 mg and 5 mg

Deepthi | Myequity news | Date : 10-12-2018 16:15:00 IST

Lupin has received tentative approval for its Apixaban Tablets, 2.5 mg and 5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Bristol-Myers Squibb Company’s Eliquis® Tablets, 2.5 mg and 5 mg.

Lupin’s Apixaban Tablets, 2.5 mg and 5mg is the generic version of Bristol-Myers Squibb Company’s Eliquis® Tablets, 2.5 mg and 5 mg.

It is indicated for:

• reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation.

• prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), following hip or knee replacement surgery.

• treatment of DVT and PE and

• reducing the risk of recurrent DVT and PE.

Eliquis® Tablets, 2.5 mg and 5 mg had annual sales of approximately USD 6366 million in the US (IQVIA MAT September 2018).


About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.


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