Merck has received a not approvable letter from the FDA to its new drug application seeking approval for over-the-counter Mevacor (lovastatin) 20 mg.
In December 2007, the FDA’s joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted (10-2) against recommending approval of the OTC use of Mevacor. The FDA followed the recommendations of these committees.
Mevacor over-the-counter (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.