FDA Advisory Panel Recommends Against Approval Of Merck’s NDA For Non Prescription MEVACOR® (lovastatin) 20 Mg

Merck & Co., Inc. announced that the U.S. Food and Drug Administration’s (FDA) 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. [click link for full article]

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Filed under: Cholesterol on December 20th, 2007