FDA Panel Rejects OTC Status for Merck’s “Mevacor”
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.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
