FDA rejects Mercks third attempt to make Mevacor OTC
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.
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.