First Generics of Eliquis Receive Approval

The Food and Drug Administration (FDA) has approved the first generics of Eliquis (apixaban; Bristol-Myers Squibb and Pfizer) tablets.

Apixaban, a factor Xa inhibitor, is indicated:

  • To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
  • 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
  • For the treatment of DVT or PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy

The generic version will be dispensed with a Medication Guide to instruct patients on its proper use and drug safety information.

“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, MD, director of the FDA’s Center for Drug Evaluation and Research. “These approvals mark the first generic approvals of a direct oral anticoagulant.”

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Currently, Micro Labs Limited and Mylan Inc have received approvals to manufacture apixaban tablets. The generic product will be available in 2.5mg and 5mg strengths.

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