FDA rejects Merck's Mevacor OTC bid
An FDA advisory panel has rejected Merck's bid to sell the cholesterol-lowering drug Mevacor without a prescription.
The panel voted 10-2 against recommending OTC sales of the drug.
The rejection marks the third time a global drugmaker has failed to win FDA approval for Mevacor's non-prescription status.
Merck's Edwin Hemwall VP, global OTC regulatory and scientific affairs. “We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider."
Although the FDA is not bound by its panel recommendations, it does take expert advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.