The FDA has approved the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The first two approvals of the blood thinner were granted to Micro Labs and Mylan.
Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
Additionally, the treatment 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,” said Janet Woodcock, Director of the FDA’s Centre for Drug Evaluation and Research.
“These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”