First Generic Applications of Eliquis Approved
FDA approved two generic applications of direct oral anticoagulant
THURSDAY, Dec. 26, 2019 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first generics of Eliquis (apixaban) tablets, the agency announced Monday.
The generic applications are approved to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip or knee replacement surgery, and for treatment of and to prevent recurrence of DVT and pulmonary embolism.
Apixaban is dispensed with a Medication Guide, and health care professionals should counsel patients on signs and symptoms of possible bleeding, the FDA noted. Patients being treated with apixaban have an increased risk for thrombotic events if they stop taking the drug too early. There is also a risk for epidural or spinal hematomas in patients who are also receiving neuraxial anesthesia or undergoing spinal puncture.
Apixaban is contraindicated in patients with prosthetic heart valves and those with atrial fibrillation that is caused by a heart valve problem. Bleeding is the most serious risk of apixaban.
The generic apixaban approvals were granted to Micro Labs Limited and Mylan Pharmaceuticals.