Generic Versions of Blood-Thinning Plavix Approved

THURSDAY, May 17, 2012 (HealthDay News) -- The first generic versions of the blood-thinning drug Plavix (clopidogrel bisulfate) have been approved by the U.S. Food and Drug Administration.

Brand-name Plavix, made by Brisol-Myers Squibb and Sanofi, was first FDA approved in 1997 to help prevent blood clots that could cause heart attack or stroke. It has been sanctioned for people who have had a recent heart attack or stroke, or who have at least a partial artery blockage, the agency said in a news release.

The drug has a boxed label warning that it may not be effective for people who have certain genetic traits, or for those who take proton pump inhibiting drugs that are commonly prescribed to prevent gastroesophageal reflux disease.

Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals received approval for 300 milligram clopidogrel. Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals received approval for 75 milligram clopidogrel.

Generic drugs must meet the same high quality standards as their brand-name counterparts and must be chemically equivalent, the agency said.

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