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In Brief: Cholestin

This article was originally published in The Tan Sheet

Executive Summary

Cholestin: FDA agrees to accept additional data from Pharmanex following the Jan. 30 close of the public comment period on the regulatory status of Cholestin, which is marketed by the company as a dietary supplement for healthy cholesterol. At a Jan. 20 meeting with the agency, Pharmanex requested more time to reply to any "significant submissions" made at the end of the comment period. Merck filed substantial comments Jan. 30 arguing that Cholestin should be considered an unapproved new drug ("The Tan Sheet" Feb. 9, pp. 17-18). The product contains HMG-CoA reductase inhibitors including lovastatin, the active ingredient in Merck's prescription cholesterol-reducing drug, Mevacor...

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