Dr. Reddy’s, Sun Pharma, 9 others get FDA nod for generic version of Plavix

The US Food and Drug Administration (FDA) yesterday approved selling of generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), the world's second-best-selling medicine, marketed jointly by Bristol-Myers Squibb Co and Sanofi SA.

This will allow Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals to manufacture 300 milligram (mg) clopidogrel, while Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.

Plavix helps reduce the risk of heart attack and stroke by making it less likely for platelets in the blood to clump and form clots in the arteries.

Clopidogrel 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 (peripheral artery disease).
The move will bring down the cost of the medicine dramatically from about $200 to $40 or less each month.

''For people who must manage chronic health conditions, having effective and affordable treatment options is important,'' said Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research.

''The generic products approved today will expand those options for patients,'' he added.