Merck Receives Not Approvable Letter from FDA for OTC MEVACOR® (lovastatin) 20 mg

WHITEHOUSE STATION, N.J.- 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.

The FDA indicated in its letter that it would require a revised label and additional data from Merck in order to gain marketing approval. “We’re evaluating the conditions outlined in the agency’s response to determine a path forward for MEVACOR OTC,” said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.