FDA Approves Generic Versions Of Blood Thinning Drug Plavix

Date : 05/17/2012 @ 3:17PM
Source : Dow Jones News
Stock : Sanofi American Depositary Shares (Each Repstg One-Half of One Ordinary Share) (SNY)
Quote : 39.68  -0.23 (-0.58%) @ 1:14PM
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FDA Approves Generic Versions Of Blood Thinning Drug Plavix

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The U.S. Food and Drug Administration on Thursday approved generic versions of blood-thinning drug Plavix.

Plavix, marketed by Bristol-Myers Squibb Co. (BMY) and Sanofi (SNY), is used to ward off heart attacks and strokes in people with cardiovascular disease, and was among the best-selling drugs in history. The drug's $6.8 billion in U.S. sales last year, as tallied by IMS Health, ranked second behind Pfizer Inc.'s (PFE) Lipitor, which is used to treat high cholesterol. Plavix's U.S. patent expired Thursday, clearing the way for generic versions of the drug, which carries the generic name clopidogrel.

The FDA said it approved Gate Pharmaceuticals, Mylan Pharmaceuticals (MYL) and Teva Pharmaceuticals (TEVA) to sell a 300-milligram dose of clopidogrel. Teva and Mylan have also been granted approval to sell a 75-milligram dose of the drug along with Apotex Inc., Aurobindo Pharma (524804.BY), Roxane Laboratories, Sun Pharma (524715.BY), and Torrent Pharmaceuticals Ltd. (500420.BY).

Clopidogrel is FDA-approved to treat patients who have recently had a heart attack or stroke, or have partial or total blockage of an artery, FDA said.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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