Mevacor Rejected for Over-The-Counter Use

Merck’s prescription drug Mevacor, prescribed for lowering cholesterol, was rejected on January 14, 2005. Find out why the Food and Drug Administration (FDA) Advisory Committee rejected Mevacor and what the committee suggested Merck should do now.
Mevacor Rejected for Over-The-Counter Use
Merck’s drug, Mevacor, is currently a prescription medication taken for high cholesterol. Recently, Merck submitted clinical data to the FDA for permission to market an over-the-counter (OTC) version of the drug with the proposed tradename of Mevacor Daily.

A joint FDA Advisory Committee reviewed the clinical data and met on January 14, 2005 to vote. Mevacor Daily was rejected by the joint committee 20-3. Some committee members "felt that the current OTC system is not adequate for patients to make an appropriate assessment about whether they require a cholesterol-lowering drug that would be used on a chronic basis."

Committee members did not believe the safety and efficacy of the drug was in question, however they agreed that patients would be "better served under a system that provides more guidance to patients."

Although this was the second rejection to bring Mevacor to OTC status (the first rejection was in July 2000) the joint committee members encouraged Merck to continue their efforts to bring the drug to store shelves.

Source: FDAAdvisoryCommittee.com

If you would like to receive my newsletter, click here.


Discussion:

Do you think the FDA’s Advisory Committee’s conclusions were founded?
Express your thoughts below in the "What do you think?" section.

   By Stacey Lloyd
Published: 1/19/2005
 
Use the feedback form below to submit your comments.
Your Comments:
Your Name:
Use the form below to email this article to your friends.
Recipient Email Address:
 Separate multiple email addresses by ;
Your Name:
Your Email Address:
HealthSquare.com
Drug Information - Mevacor

FDA Advisory Committee
Information about activities of FDA Advisory Committees