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This article was originally published in The Tan Sheet

Executive Summary

Data support OTC laxative ingredient's classification as Category I, FDA tells Boehringer Ingelheim in a Feb. 16 letter. The agency finds the company's carcinogenicity testing of bisacodyl on heterozygous p53 transgenic mice is "acceptable" and "no further carcinogenicity testing of bisacodyl is recommended." FDA requested further safety data on bisacodyl, senna, cascara sagrada and aloe, and tentatively reclassified them from Category I (safe and effective) to Category III (further testing needed) on June 19, 1998. Novartis Consumer Health, Madaus AG, Purdue Pharma and Reckitt & Colman have agreed to conduct a two-year safety study on senna

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