FDA approval of Plavix
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Last Update: 2012-05-18
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Source: Internet
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Author: User
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Source: China Council for the promotion of drugs 2012-05-18 the US Food and Drug Administration today approved the generic drug Plavix (clopidogrel sodium bisulfate), a blood thinning drug, which helps reduce heart attack and the risk of stroke due to platelet aggregation in the blood and arterial thrombosis Clopidogrel is an FDA approved treatment for patients with recent heart attacks, strokes, and partial or total arterial embolism (peripheral arterial disease) "For people who have to manage chronic diseases, it's important to have effective and affordable treatments." Dr Keith Weber, deputy director of the office of drug technology at the FDA drug evaluation and Research Center, said "Today's approval of generic drugs will expand patient choice." Clopidogrel has a black box warning to remind medical professionals and patients that some genetic factors that affect the metabolism of the drug may cause the drug to fail to work properly Patients can pass these genetic factor tests to ensure that clopidogrel is the right choice for them In addition, certain drugs, such as the proton pump inhibitors Losec and Nexium (omeprazole), reduce the efficacy of clopidogrel and increase the risk of heart attack and stroke Clopidogrel can cause bleeding, which can be severe and sometimes cause death When taking the drug, people may be more prone to bruising, bleeding, epistaxis and taking longer to stop bleeding Clopidogrel has patient medication guidelines with information on its use and drug safety Dr Reddy's laboratory, gate pharmaceutical, Milano pharmaceutical and TIWA pharmaceutical have been approved by FDA to imitate 300mg of clopidogrel Apotex, albedo pharmaceuticals, mylan pharmaceuticals, Roxane laboratories, sunpharma, Teva pharmaceuticals and torrent pharmaceuticals have received approval to replicate 75 mg of clopidogrel The quality of generic drugs approved by FDA is the same as that of commercial drugs The quality standard of drugs with the same trade name must be used in the manufacturing and packaging places of generic drugs Information on the availability of the clopidogrel generic can be obtained from the manufacturer Original link: http://
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