"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," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency news release.
The two types of generic tablets were approved to reduce the risk of stroke and systemic clotting in the lungs of patients with non-valvular atrial fibrillation and for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (lung clots), in patients who have had hip or knee replacement surgery.
Atrial fibrillation is a heart rhythm disorder that raises the risk of blood clots. It is estimated that between almost 3 and 6 million Americans have atrial fibrillation, according to the U.S. Centers for Disease Control and Prevention. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk, the FDA noted.
There is an increased risk of blood clots forming inside a blood vessel, or strokes, if a patient stops using apixaban too early, the agency said.
Patients with prosthetic heart valves should not take apixaban nor should patients with atrial fibrillation that is caused by a heart valve problem. As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.
The generic apixaban approvals were granted to Micro Labs Limited and Mylan Pharmaceuticals Inc.