FDA Again Denies Merck’s Request for OTC “Mevacor” - Pharmaceutical Technology

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FDA Again Denies Merck’s Request for OTC “Mevacor”


ePT--the Electronic Newsletter of Pharmaceutical Technology

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Whitehouse Station, NJ (Jan. 25)—The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter (OTC) use of “Mevacor” (lovastatin) 20 mg. FDA’s letter indicates a revised label would be required as well as additional data from Merck.

This decision follows the FDA’s Nonprescription Drugs Advisory and Endocrinologic and Metabolic Drugs Advisory committees’ recommended rejection in December of 2007. Edwin L. Hemwall, PhD, Merck’s Vice President of Global OTC Regulatory and Scientific Affairs, said the company is “evaluating the conditions outlined in the agency’s response to determine a path forward for ‘Mevacor’ OCT.”

Under review by FDA since 1999, not approvable letters were also issued in 2000 and 2005. “Mevacor” is designed to reduce LDL cholesterol levels in patients.

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