Mevacor OTC Study Shows Cholesterol-Lowering Consistent With Rx Statins
This article was originally published in The Tan Sheet
Executive Summary
A cholesterol self-management program for OTC Mevacor was effective in deterring consumers from improperly purchasing the nonprescription version of the cholesterol-lowering drug, results from the CUSTOM actual-use study show
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Mevacor meeting
FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees will convene Jan. 13-14 to consider J&J/Merck's NDA proposing an Rx-to-OTC switch of Mevacor (lovastatin 20 mg), the agency confirms Dec. 3. The meeting will begin at 8 am both days at the Holiday Inn, Bethesda, Md. J&J/Merck will present recently published data from its CUSTOM actual-use study in support of the switch (1"The Tan Sheet" Nov. 22, 2004, p. 8)...