FDAnews
www.fdanews.com/articles/101466-gsk-obtains-marketing-rights-to-mevacor-fda-to-review-nda

GSK Obtains Marketing Rights to Mevacor, FDA to Review NDA

November 27, 2007

GlaxoSmithKline (GSK) and Merck have entered an agreement for OTC marketing rights for Mevacor, a cholesterol-reducing drug.

GSK will have exclusive rights to market nonprescription Mevacor (lovastatin) in the U.S. Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck, GSK said.

Mevacor was introduced in the U.S. in 1987 by Merck as the first in a class of cholesterol-reducing medicines known as statins. The drug’s U.S. patent expired in 2001.

The new drug application (NDA) for OTC Mevacor will be reviewed by the FDA in a joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee Dec.13. The NDA, which was filed by Merck, is seeking approval of OTC Mevacor 20 mg taken once daily.