FDA Approves Generic Plavix
- Wed, 5/23/12 - 4:13pm
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On May 17, 2012, the FDA approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of stroke by making it less likely that platelets in the blood will form clots in the arteries.
The FDA granted approval to Dr. Reddy's Laboratories, Gate Pharmceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals to manufacture the drug in 300 mg clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.
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). Clopidogrel may cause bleeding, which can be serious and sometimes be fatal. While taking the drug, patients may bruise and bleed more easily, be more likely to have nose bleeds, and it may take longer for all bleeding to stop.
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.