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FDA Approves Generic Versions of Plavix
Date:5/18/2012

ken along with aspirin, which acts as a blood thinner to prevent heart attack and stroke.

Clopidogrel is commonly used by patients with heart-related chest pain, unstable heart disease or those who have had a stent implanted to open a blocked artery.

Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals won FDA approval Thursday for their generic versions of 300 milligram (mg) Plavix.

Apotex Corp., Aurobindo Pharma, Roxane Laboratories, Sun Pharma, Torrent Pharmaceuticals, Mylan and Teva won approval for lower-dose versions (75 mg), the FDA added.

"The most important impact of the availability of generics will be to reduce costs for patients and health systems where clopidogrel is already indicated," said Dr. Ralph Sacco, chairman of neurology at the University of Miami School of Medicine and former president of the American Heart Association.

The drug doesn't work for everyone, however. Some patients can't metabolize it, which reduces its effectiveness.

In addition, new drugs are available that may be better than clopidogrel, Fonarow said.

"Newer antiplatelet agents, such as prasugrel [Effient] and ticagrelor [Brilinta], have been shown to be more effective] than clopidogrel, and for many patients these [drugs] may be a better choice, despite higher cost," Sacco said.

Plavix, even in a less expensive version, can't replace other clot-preventing drugs, such as warfarin, in certain patients.

For example, Plavix is not recommended for patients with an irregular heartbeat, called atrial fibrillation, who take blood thinners to prevent strokes. A 2009 report in the New England Journal of Medicine said patients with atrial fibrillation who took Plavix were at an unacceptably high increased risk of severe bleeding.

More information

For more information on clopidogrel, visit the U.S. National Instit
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