Merck Receives Not Approvable Letter From FDA For OTC MEVACOR® (lovastatin) 20 Mg

Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR® (lovastatin) 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions.

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Filed under: Pharma Industry on January 29th, 2008