Micro Labs and Mylan Pharmaceuticals have secured approval from the US Food and Drug Administration (FDA) for two applications for the first generics of Eliquis (apixaban) tablets to cut down the risk of stroke and systemic embolism in patients having nonvalvular atrial fibrillation.
Apixaban is also indicated for the preventive treatment of deep vein thrombosis (DVT), which may result in pulmonary embolism (PE), in patients who had hip or knee replacement surgery. Apart from that, apixaban is approved for the treatment of deep vein thrombosis and pulmonary embolism and for lowering the risk of recurrent deep vein thrombosis and pulmonary embolism after initial therapy.
Janet Woodcock – director of the FDA Center for Drug Evaluation and Research said: “Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines.
“These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”