Clopidogrel reaches milestone
MedWire News: The US Food and Drug Administration (FDA) has approved generic versions of the oral thienopyridine antiplatelet agent clopidogrel.
The drug, marketed jointly by Bristol-Myers Squibb and Sanofi as Plavix, is approved for patients who have recently experienced myocardial infarction or stroke and those with peripheral artery disease.
The FDA says generic drugs are crucial options that allow improved access to healthcare.
"For people who must manage chronic health conditions, having effective and affordable treatment options is important," commented Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in a press statement.
"The generic products approved today will expand those options for patients."
As with the branded version, generic clopidogrel will be issued with a boxed warning to alert healthcare professionals and patients it may not be effective for patients who have gene variants associated with an inability to convert clopidogrel to its active metabolite. These patients can be tested to ensure that clopidogrel is appropriate for them.
In addition, the warning emphasizes that omeprazole, brand name Prilosec (AstraZeneca, Södertälje, Sweden), and esomeprazole, brand name Nexium (AstraZeneca, Södertälje, Sweden), could diminish the antiplatelet effect of clopidogrel.
The side effects of clopidogrel, including bleeding, will be outlined in an accompanying patient medication guide. The FDA warns that patients taking the drug may bruise and bleed easily, be more likely to have nose bleeds, and that their bleeding may take longer to stop than those who do not take it.
The Agency stresses that generic drugs are "of the same high quality and strength of brand-name drugs." They add that the generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.
Dr Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceutics have obtained approval from the FDA for clopidogrel 300 mg. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have obtained approval for clopidogrel 75 mg.
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By Piriya Mahendra