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Pfizer changes Lipitor ad

Executive Summary

FDA objects to eight-page journal ad for Pfizer's Lipitor (atorvastatin) in July 12 letter on the grounds that it implies a claim for the off-label indication of prevention of coronary heart disease. Ad depicts "apparent candidates for Lipitor" wearing nametags saying they have hyperlipidemia and another coronary heart disease risk factor, agency notes. The ad "creates an overwhelming impression that Lipitor is indicated to reduce the risk of developing coronary heart disease," FDA concludes. Atorvastatin is not approved for that claim. Pfizer discontinued the ad and plans to introduce a new journal ad

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