Merck & Co., Inc. recently announced that the FDA’s joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval at this time of the over-the-counter (OTC) use of MEVACOR® (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack. “We are disappointed in today’s outcome. We felt we presented a compelling case to the committee that non-prescription MEVACOR 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider,” said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs. The FDA is not bound by the committee’s recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008. MEVACOR is a prescription medicine that is approved in the U.S. for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularization procedures in healthy men and women with average or moderately elevated cholesterol levels.
