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FDA Approves Generic Versions of Clopidogrel Bisulfate (Plavix)

On May 17, the Food and Drug Administration (FDA) approved generic versions of clopidogrel bisulfate (Plavix) used to treat patients who have had a recent heart attack or stroke, or who have peripheral artery disease.

Clopidogrel contains a boxed warning for health professionals and patients, noting that the drug may not work well for patients with certain genetic factors that affect how the body metabolizes the drug. In addition, certain medicines like proton pump inhibitors omeprazole (Prilosec) and esomeprazole (Nexium) reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke. Clopidogrel may also cause bleeding.

According to the FDA, approved generic drug manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs. Information about the availability of generic clopidogrel can be obtained from the manufacturers.

Read the complete FDA release.

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