FDA rejects Mercks third attempt to make Mevacor OTC

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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.