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

Mumbai: Through a recent BSE filing, drug firm Lupin said it has received a tentative nod from the US health regulator to market its generic Apixaban tablets.

The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Apixaban tablets in the strengths of 2.5 mg and 5 mg.

Apixaban tablet 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.

The product is a generic version of Bristol-Myers Squibb Company's Eliquis tablets in the same strengths, it added.

Eliquis tablets 2.5 mg and 5 mg had annual sales of approximately $6,366 million in the US, Lupin added.

Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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