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FDA approves first generic version of popular blood thinner drug

The first generic versions of the powerfulblood thinnerEliquis(apixaban) were approved by the U.S. Food and Drug Administration.

“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.

"These approvals mark the first generic approvals of a direct oral anticoagulant," Woodcock noted. "Direct oralanticoagulants[blood thinners] do not require repeated blood testing."

The two types of generic tablets were approved to reduce the risk ofstrokeand systemic clotting in the lungs of patients with non-valvular atrial fibrillationand for the prevention ofdeep vein thrombosis(DVT), which may lead topulmonary embolism(lung clots), in patients who have had hip or knee replacement surgery.

Atrial fibrillationis a heart rhythm disorder that raises the risk ofblood 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.

The generic apixaban approvals were granted to Micro Labs Limited and Mylan Pharmaceuticals Inc.