THURSDAY, May 17 (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 Sanofi Aventis, 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.
Approval to produce generic versions of the drug was granted to: Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals, the FDA said.
Generic drugs must meet the same high quality standards as their brand-name counterparts and must be chemically equivalent, the agency said.
To learn more about this drug, visit Medline Plus.
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