FDA Approves Generic Plavix

The FDA announced the approval of generic versions of Plavix (clopidogrel bisulfate; Bristol-Myers Squibb and Sanofi) tablets. Plavix 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.

Currently, Dr. Reddy’s Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300mg clopidogrel tablets. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75mg clopidogrel tablets.

Plavix is a platelet aggregation inhibitor indicated in reduction of atherosclerotic events in: recent myocardial infarction (MI) or stroke, established peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina/non-ST-elevation MI) or ST-elevation MI.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm304489.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=plavix&utm_content=1.