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Lescol expanded indication

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA clears Novartis' Lescol and Lescol XL (fluvastatin) May 27 "to reduce the risk of undergoing coronary revascularization procedures" based on the Lescol Intervention Prevention Study (LIPS). Labeling states that "Lescol significantly reduced the risk of cardiac events by 22% (p=0.013, 181 patients in the Lescol group vs. 222 patients in the placebo group). Revascularization procedures comprised the majority of the initial cardiac events (143…in the Lescol group and 171 in the placebo group)." Lescol is the first statin to receive the indication. U.S. marketer Reliant plans to initiate a marketing campaign for both consumers and professionals in Jun
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