Mylan's generic version of blood-thinner Plavix gets FDA approval

Clopidogrel - known in branded form as Plavix - is the blood-thinning drug taken by millions of people with heart disease to avoid heart attacks and strokes and it will soon be on pharmacy shelves as a generic drug.

Plavix was made through a partnership of Sanofi-Aventis and Bristol-Myers Squibb and had U.S. sales of approximately $6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.

This drug is for people who have already had some history of heart disease and need to avoid clotting problems that might lead to further heart attacks or a stroke.

The U.S. Food and Drug Administration approved generic versions this week.

“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research said in an FDA statement after the approval was announced Thursday. “The generic products approved today will expand those options for patients.”

Pittsburgh-based Mylan Pharmaceuticals was the first to file an application for generic approval so it will have six months as the only generic on the market. Mylan said in a statement that it will begin shipping tablets immediately.

After six months, other companies can sell versions, so the generic prices will drop more then.

The FDA said that Teva Pharmaceuticals, Dr. Reddy's Laboratories, Gate Pharmaceuticals and Mylan were approved for 300 milligram tablets of clopidogrel. Teva, Apotex Corporation, Aurobindo Pharma, Mylan, Roxane Laboratories, Sun Pharma and Torrent Pharmaceuticals got approval for the 75 milligram dosage.

A link to the FDA primer on generic drugs is here.