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Bisacodyl, senna OTC laxative safety data requested by June 1999 in FDA proposal.

This article was originally published in The Tan Sheet

Executive Summary

BISACODYL, SENNA OTC LAXATIVE SAFETY DATA REQUESTED BY JUNE 1999 in an FDA proposed rule published in the June 19 Federal Register. As expected, the proposal tentatively reclassifies senna, bisacodyl, cascara sagrada and aloe from Category I (safe and effective) to Category III (further testing needed) in the tentative final monograph for OTC laxatives and reopens the administrative record for data considered necessary to establish the safety of the ingredients.
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