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Generic clopidogrel now available
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Today, the FDA approved generic versions of clopidogrel bisulfate, formerly known as Plavix.
Clopidogrel is FDA approved to treat patients who have had a recent MI or stroke or patients who have peripheral artery disease.
“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” Keith Webber, PhD, 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.”
Clopidogrel has a boxed warning to alert health care professionals and patients that the drug may not work well in those with certain genetic factors and that certain medicines may reduce the drug’s effect.
Bristol-Myers Squibb and Sanofi Aventis formerly held the patent for clopidogrel. As of press time, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals have gained FDA approval for 300 mg clopidogrel. Apotex Corporation, Aurobino Pharma, Myland Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel, according to a FDA press release.
Information about the availability of generic clopidogrel can be obtained from the manufacturers.