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FDA gives Lupin's generic Eliquis tentative approval

12/11/2018
Lupin has received tentative approval from the Food and Drug Administration for generic Eliquis tablets (apixaban tablets). The generic will be available in 2.5-mg and 5-mg dosage strengths.

Lupin's generic Eliquis is indicated for reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation; prophylaxis of deep vein thrombosis,  which may lead to pulmonary embolism following hip or knee replacement surgery; and treatment of deep vein thrombosis and pulmonary embolism, as well as reducing risk of both events recurring.

The product had a market value of roughly $6.4 billion according to September 2018 IQVIA data.
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