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FDA Mevacor OTC Switch Answer: Signs Point To “Not Approvable”

This article was originally published in The Tan Sheet

Executive Summary

FDA appears to have issued a "not approvable" letter in response to J&J/Merck's application to switch the cholesterol-lowering drug Mevacor (lovastatin 20 mg) over the counter

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Use of statins and beta-blockers in individuals with no history of coronary disease may be correlated with a reduced risk of more serious cardiovascular events, a study in the Feb. 21 Annals of Internal Medicine finds

Study Bolsters Statin Myocardial Infarction Prevention Evidence

Use of statins and beta-blockers in individuals with no history of coronary disease may be correlated with a reduced risk of more serious cardiovascular events, a study in the Feb. 21 Annals of Internal Medicine finds

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