Micro Labs, Mylan get FDA OK for generic Eliquis

The Food and Drug Administration has approved two applications for the first generics of Bristol-Myers Squibb's Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Micro Labs and Mylan were the manufacturers whose generics were approved. 

Apixaban also is indicated for the prophylaxis of deep vein thrombosis, or DVT which may lead to pulmonary embolism or PE in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.

"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," Janet Woodcock, director of the Food and Drug Administration's center for drug evaluation and research, said. "These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing."