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Novartis files Lescol/Lescol XL sNDAs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis submits sNDAs for Lescol and Lescol XL (fluvastatin) for secondary prevention of cardiovascular events in patients who have undergone percutaneous coronary intervention (PCI) August 1, based on the four-year Lescol Intervention Prevention Study (LIPS). The study, published June 26 in the Journal of the American Medical Association, found that fluvastatin treatment in patients "with average cholesterol levels undergoing their first PCI significantly reduces the risk of major adverse cardiac events." Novartis is touting fluvastatin as the first statin to seek such an indicatio

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