Cholestin "designed" to be different from red yeast rice, Merck argues in comments.
This article was originally published in The Tan Sheet
Executive Summary
CHOLESTIN "DESIGNED" TO BE DIFFERENT FROM RED YEAST RICE, MERCK argues in Jan. 30 comments to FDA. In a 14-page submission with several attachments, the marketer of Mevacor (lovastatin) reiterates and expands earlier arguments that the red yeast rice product marketed by Pharmanex as a dietary supplement is a "generic lovastatin product that was designed as, and is being aggressively marketed as, a generic alternative to Mevacor." Merck's earlier comments on Cholestin were submitted in May ("The Tan Sheet" Jan. 5, p. 3).