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

News
Article

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.

 

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes