May 18, 2012 6:58 PM
"For people who must manage chronic health conditions, having effective and affordable treatment options is important," says Keith Webber, PhD, of the FDA's Center for Drug Evaluation and Research, in a news release. "The generic products approved today will expand those options for patients."
Major pharmacy chains say they expect to have the generic versions of clopidogrel in stock within days of the approval.
Plavix was approved by the FDA in 1997 and is marketed in the U.S. by Bristol-Myers Squibb. The U.S. patent on the drug expired on May 17, paving the way for the FDA's approval of generic versions.
Generic drugs approved by the FDA must be of the same quality and strength as the brand-name versions.
Clopidogrel is approved to treat people who have had a recent heart attack or stroke or who have plaque buildup in arteries known as peripheral artery disease.
The drug works by making the platelets in the blood less likely to clump and form clots that could lead to a heart attack or stroke.
The FDA approved three 300-milligram (mg) generic versions of clopidogrel and seven generic 75-mg versions.
Generic clopidogrel, like Plavix, may not work in people with certain genetic risk factors that affect how the drug is metabolized in the body. A genetic test can check for these factors.
Possible side effects of clopidogrel include bruising and excessive bleeding, which can be life-threatening in some cases.