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In Brief: Pharmanex

This article was originally published in The Tan Sheet

Executive Summary

Pharmanex: Withdraws complaint against FDA seeking court declaration that cholesterol-lowering claims for its Cholestin dietary supplement are appropriate under the Dietary Supplement Health & Education Act and are not unapproved new drug claims. The complaint was filed in Salt Lake City, Utah federal court April 7 ("The Tan Sheet" April 14, p. 1). FDA filed a motion to dismiss the complaint April 30 on the basis that the matter was not "ripe for review" ("The Tan Sheet" May 12, In Brief). Pharmanex' motion to voluntarily dismiss the action "without prejudice" is dated May 8. The company and FDA are in discussions regarding the agency's position that the claims are inappropriate...





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