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Stimulant laxatives phenolphthalein, bisacodyl to be reclassified as Category III -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

OTC LAXATIVE PHENOLPHTHALEIN TO BE RECLASSIFIED AS CATEGORY III (more data needed) from Category I (safe and effective), FDA OTC Division Director Debra Bowen said in a May 10 "feedback" letter to the Nonprescription Drug Manufacturers Association. The letter also was sent to individual laxative manufacturers including Schering-Plough (Correctol), Sandoz (Ex-Lax) and Pharmacia & Upjohn (Doxidan).





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