FDA

FDA Approves New Applications for Apixaban

The US Food and Drug Administration (FDA) approved two new applications for the first generics of Eliquis (apixaban) tablets: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

“[These] 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. Direct oral anticoagulants do not require repeated blood testing.”

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

—Amanda Balbi

Reference:

FDA approves first generics of Eliquis [press release]. Silver Spring, MD: US Food and Drug Administration; December 23, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis.