FDA issues nonapprovable letter over Merck's Mevacor OTC

WHITEHOUSE STATION, N.J. Merck may yet make a fourth attempt at switching its statin Mevacor over-the-counter, but the Food and Drug Administration officially declined its third attempt, the company reported Friday.

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,” stated Edwin Hemwall, Merck president, global OTC regulatory and scientific affairs.