Merck announced that it has been advised that the new drug application (NDA) for over-the-counter (OTC) Mevacor (lovastatin) will be reviewed by the US Food and Drug Administration's (FDA) joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee on December 13, 2007. An advance notice of the meeting will appear shortly on the FDA's website, and will be published in the FDA Federal Register.
Merck is seeking approval of OTC Mevacor (lovastatin) 20 mg taken once daily to help lower cholesterol, which may prevent a first heart attack. The company looks forward to presenting data from the clinical programme in December.
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