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FDA Approves Generic Versions Of Clot-buster Plavix


The FDA on Thursday approved generic versions of blood thinning drug Plavix, which helps reduce the risk of heart attack and stroke. Known chemically as Clopidogrel, Plavix is marketed in the U.S. by Bristol-Myers Squibb Co. (BMY) and Sanofi (SNY), and is available in strengths of 75 mg and 300 mg.

Clopidogrel is indicated for the treatment of patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery. Clopidogrel's label sports a black-box warning to alert that the drug may not work well in patients with a genetic variation who cannot metabolize the drug, putting them at increased risk for heart attack and stroke.

Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, a subsidiary of Mylan Inc. (MYL) and Teva Pharmaceutical Industries Ltd. (TEVA)are the companies that have gained FDA approval for 300 milligram Clopidogrel.

Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg Clopidogrel.

According to IMS Health, Plavix had U.S. sales of about $6.7 billion for the 12 months ended March 31, 2012.

by RTTNews Staff Writer

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