Generic versions of plavix approved

May 18, 2012
Generic versions of plavix approved

(HealthDay) -- 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 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 .

Explore further: FDA panel unanimously votes down Parkinson's drug

More information: To learn more about this drug, visit Medline Plus.

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