FDA rejects Merck's Mevacor OTC bid

Share this article:

An FDA advisory panel has rejected Merck's bid to sell the cholesterol-lowering drug Mevacor without a prescription.

The panel voted 10-2 against recommending OTC sales of the drug.

The rejection marks the third time a global drugmaker has failed to win FDA approval for Mevacor's non-prescription status.

Merck's Edwin Hemwall VP, global OTC regulatory and scientific affairs. “We are disappointed in today's outcome.  We felt we presented a compelling case to the committee that non-prescription 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 the FDA is not bound by its panel recommendations, it does take expert advice into consideration.  The anticipated action date by the FDA is Jan. 26, 2008.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.