Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) approval for its generic version of the blood thinner Plavix (clopidogrel bisulfate). The drug helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
Teva, Mylan Inc. (NYSE: MYL), Apotex Corporation, Roxane Laboratories Inc. of the US, India's Sun Pharmaceutical Industries Ltd. (BSE: 524715) Aurobindo Pharma Ltd. (BSE: 524804) and Torrent Pharmaceuticals, obtained marketing approval for 75 milligram tablets of generic Plavix, and Teva USA unit Gate Pharmaceuticals, Mylan, India's Dr. Reddy's Laboratories Ltd. (BSE: 500124, NYSE: RDY), obtained marketing approval for 300 milligram tablets. Mylan obtained 180-days marketing exclusivity for the 75-mg tablets, and Dr. Reddy's obtained 300-days marketing exclusivity for the 75-mg tablets
Brand Plavix, sold by Bristol-Myers Squibb Co. (NYSE: BMY) and Sanofi-Aventis SA (Euronext: SAN; NYSE: SNY; LSE: 0I42; DAX: SNW) has $6.7 billion in annual sales in the US.
The FDA approves clopidogrel for treating patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery (peripheral artery disease).
Published by Globes [online], Israel business news - www.globes-online.com - on May 20, 2012
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