Lovastatin content in Cholestin renders product unapproved new drug -- FDA.
This article was originally published in The Tan Sheet
Executive Summary
LOVASTATIN CONTENT RENDERS CHOLESTIN UNAPPROVED NEW DRUG, not a dietary supplement, FDA maintains in a Sept. 30 letter to Pharmanex outside counsel Patton Boggs (Washington, D.C.). "Based on information presently before the agency, FDA believes that in marketing Cholestin, Pharmanex intends to market, and in fact is marketing, lovastatin, an article approved in 1987...as the prescription drug Mevacor," the letter states. Mevacor is marketed by Merck.
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