FDA Panel Rejects OTC Status for Merck’s “Mevacor”

December 28, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Merck & Co.'s “Mevacor” (lovastatin) 20 mg.

Whitehouse Station, NJ (Dec. 13)-The US Food and Drug Administration’s joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter (OTC) use of Merck & Co.’s “Mevacor” (lovastatin) 20 mg. The drug is designed to help lower LDL cholesterol, which may prevent a first heart attack.

“We are disappointed in today’s outcome,” said Edwin L. Hemwall, vice-president of global OTC regulatory and scientific affairs at Merck, in a company release. “We felt we presented a compelling case to the committee that nonprescription 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 FDA is not bound by the committee’s recommendation, the agency takes its advice into consideration. FDA is expected to take action by Jan. 26, 2008, according to Merck.