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

Latest Issue

Latest Issue
PharmTech Europe

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

ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

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.



blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here