FDA Approves Generic Versions Of Blood Thinning Drug Plavix
May 17 2012 - 3:17PM
Dow Jones News
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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