FDA Denies OTC Bid for Mevacor
A U.S. Food and Drug Administration panel Thursday denied a bid by Merck & Co. to sell Mevacor as an over-the-counter medication to lower cholesterol.
The application was denied by a vote of 10-2 on concerns that the drug could be misused if taken without consulting a medical professional.
This is the third time Merck has lost its bid to make Mevacor the first statin available in the United States without a prescription, the Chicago Tribune reported.
We are disappointed in today’s outcome, Edwin L. Hemwall, vice president of Merck’s Global OTC Regulatory and Scientific Affairs, said in a release. 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 health care provider.