Please login to the form below

Not currently logged in
Email:
Password:

FDA refuses Merck & Co's OTC Mevacor NDA

The FDA joint panel votes against approving the OTC sales of Merck & Co's cholesterol lowering drug Mevacor 20 mg

The FDA joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted against approving the OTC sales of Merck & Co's cholesterol lowering drug Mevacor (lovastatin) 20 mg.

The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is 26 January 2008.

UK-based pharmaceutical company GlaxoSmithKline (GSK) and Merck & Co entered into an agreement for the OTC marketing rights for Mevacor in November 2007. 

Mevacor was launched on the US market back in 1987, while the regional patent expired in 2001. The drug posted sales of around USD 20m in FY06.

The FDA rejected a similar OTC marketing request in 2005. Merck & Co argued then that OTC Mevacor could help unmedicated patients with moderate risk of heart disease.

17th December 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Clark Health Communications

Clark Health Communications (CHC) is an independent, award-winning health and medical communications agency. Our collaboration with experts and advocates enhances...

Latest intelligence

Erik
A quest for innovative solutions
UCB looks to the future through a PRISM...
Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...
Deal Watch January 2018
...

Infographics