SILVER SPRING, Md. — The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.
The FDA announced the approval of the 75-mg and 300-mg formulations of clopidogrel bisulfate, the generic form of the drug Plavix, made by Bristol-Myers Squibb and Sanofi. Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Labs, Sun Pharmaceutical Industries, Teva Pharmaceuticals and Torrent Pharmaceuticals won approval to market the 75-mg formulation, while Teva, Mylan and Gate Pharmaceuticals will make the 300-mg formulation. Dr. Reddy's also received FDA approval for the 75-mg and 300-mg strengths, including exclusivity for the latter.
The drug is a blood-thinning agent used to reduce the risk of heart attack and stroke by preventing platelets in the blood from clumping together to form clots.
With $6.8 billion in sales, Plavix was the second top-selling drug in 2011 after Pfizer's cholesterol-lowering drug Lipitor (atorvastatin calcium), according to IMS Health. Lipitor lost patent protection in November 2011.