Generic Versions of Plavix Approved

Dispensed with Medication Guide that provides important instructions on use, drug safety

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

Plavix, made by Brisol-Myers Squibb and Sanofi, 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, 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. Certain medicines, such as proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), may reduce the effect of clopidogrel.

Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have received approval for 300 milligram (mg) clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.

More information

To learn more about this drug, visit Medline Plus.

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