First Oral Anticoagulant Generics Approved
The FDA approved the first two generic tablets of Bristol-Myers Squibb’s blood thinner Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a type of irregular heart rhythm.
The approvals granted to Micro Labs and Mylan mark the first time the agency has given its go-ahead for a direct oral anticoagulant generic.
Apixaban increases the risk of thrombotic events and strokes if a patient stops taking the medication too soon, the FDA said. The drug can cause epidural or spinal hematomas in patients who are also receiving neuraxial anesthesia or are undergoing a spinal puncture, the agency warned.