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This article was originally published in The Tan Sheet

Executive Summary

Oral Carcinogenicity Study of Senna results should be available for FDA review by March 2003, Purdue Pharma tells agency in April 16 letter. Sponsored by Novartis, Reckitt & Colman, Madaus AG and Purdue, study began in January 2000 and will be completed in January 2002, with "pathology to be completed by September 2002 and an audited, draft report expected October 2002," letter states. OTC laxative tentative final monograph lists senna as Category III (more data needed); FDA inquired about study's progress so it could establish a timetable for completion of rulemaking. Four firms agreed to conduct two-year study to obtain Category I (safe and effective) status for ingredient

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