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FDA clears Plavix generics for market
May 18th, 2012
WASHINGTON – The Food and Drug Administration has approved generic versions of Plavix (clopidogrel bisulfate), a blood-thinning drug, from nine pharmaceutical manufacturers.
The FDA said Thursday that Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals have been cleared to market 300-mg clopidogrel.
Apotex, Aurobindo Pharma, Mylan, Roxane Laboratories, Sun Pharma, Teva and Torrent Pharmaceuticals received approval for 75-mg clopidogrel.
Last year Bristol-Myers Squibb and Sanofi's Plavix was the second-best-selling drug by dollar sales, totaling U.S. sales of $6.8 billion, according to IMS Health. Pfizer's Lipitor (atorvastatin calcium), which lost patent protection in November, was the top-selling drug in 2011 with U.S. sales of $7.7 billion.
Clopidogrel is FDA-approved to treat patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery (peripheral artery disease). The medication is designed to help reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
"For people who must manage chronic health conditions, having effective and affordable treatment options is important," stated Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. "The generic products approved today will expand those options for patients."