Pharmanex agrees to petition Cholestin status if FDA suspends regulatory action.
This article was originally published in The Tan Sheet
Executive Summary
PHARMANEX SEEKING STAY OF FDA ENFORCEMENT ACTION AGAINST CHOLESTIN while the company engages in the process of formally petitioning the agency to reverse its previous conclusion that the product is an unapproved new drug. The company also seeks FDA's clearance to resume importing the Chinese red yeast rice used in the production of Cholestin. In an Oct. 29 submission to the agency, Pharmanex said it is "willing to engage in a citizen petition process," but adds that it "will not engage in such a process in a context in which the agency continues to detain imported red yeast rice intended for use in Cholestin, or otherwise may enforce its ruling against the product."
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