On May 17, the FDA approved generic versions of the blood thinning drug clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), which helps reduce the risk of heart attack and stroke.
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 anticipation of this generic approval of this popular drug has led many to question its affect on the antiplatelet drug market.
“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said 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 healthcare professionals and patients that the drug may not work well for those with certain genetic factors that affect how the body metabolizes the drug. Patients can be tested for these genetic factors to ensure that clopidogrel is the right choice for them. Also, certain medicines, such as proton pump inhibitors omeprazole (Prilosec,Procter & Gamble) and esomeprazole (Nexium, AstraZeneca), reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke, according to the FDA.
The FDA added that clopidogrel may cause bleeding, which can be serious and sometimes lead to death. While taking the drug, people may bruise and bleed more easily, be more likely to have nose bleeds, and it may take longer for all bleeding to stop.
Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals have gained FDA approval for 300 mg clopidogrel. Apotex, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.
Generic drugs approved by FDA are of the same high quality and strength as brand name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.