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

By Steven Reinberg
HealthDay Reporter

THURSDAY, May 17 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved generic versions of the blood thinner Plavix (clopidogrel), making the widely used medication more affordable for those patients who need it.

"For people who must manage chronic health conditions, having effective and affordable treatment options is important. The generic products approved today will expand those options for patients," Keith Webber, deputy director of the Office of Pharmaceutical Sciences in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

A cardiology expert applauded the move.

Adherence rates will improve as a result of the lower-priced generic versions, and fewer patients will suffer from preventable cardiovascular problems, said Dr. Gregg Fonarow, director of the Ahmanson-UCLA Cardiomyopathy Center in Los Angeles.

"This medication has helped millions of patients avoid fatal and nonfatal cardiovascular events," said Fonarow, who also is a spokesman for the American Heart Association. But its high cost has "contributed to patients not filling initial prescriptions for the drug and premature discontinuation of clopidogrel," he said.

Patients who stop taking the drug prematurely may face catastrophic consequences, including fatal cardiovascular events and strokes, he added.

Sales of Plavix, made by Bristol-Myers Squibb, topped $9 billion in 2011. A generic version, at a much lower cost, is expected to eat into those sales dramatically. The drug already is sold as a generic by Sanofi in much of the European Union, according to the Associated Press.

The cost of Plavix was almost $200 a month, according to published reports. The generic versions are expected to cost much less.

Clopidogrel works by helping prevent platelets in the blood from sticking together to form clots. The drug usually is ta
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