Lupin receives tentative US FDA approval for Apixaban tabs

The drug is indicated for reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis

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.

The drug 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 $ 6366 million in the US.