Generics
US FDA approves two applications for first Eliquis (apixaban) generics
24 December 2019 -

The US Food and Drug Administration (FDA) has approved two applications for the first generics of Eliquis (apixaban) tablets to decrease the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, it was reported on Monday.

The product is also indicated for the prophylaxis of deep vein thrombosis (DVT), which is likely to lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. It is also indicated for the treatment of deep vein thrombosis and pulmonary embolism and for the reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism following initial therapy. The product will be dispensed with a Medication Guide for patients that offers instructions on its use and drug safety information.

Janet Woodcock, MD, director of the FDA's 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."

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