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Purdue Pharma

This article was originally published in The Tan Sheet

Executive Summary

Elects to conduct a two-year safety study on senna in support of the ingredient as a Category I OTC laxative ingredient. FDA had called for more data on senna in the June 19 Federal Register ("The Tan Sheet" June 22, p. 6). Purdue outlines its proposed carcinogenicity study in rats in a Sept. 3 letter to the agency, noting it already has completed the in-life phase of the preliminary dietary acceptance/intubation feasibility study and two-week oral range-finding toxicity study in the rat. NDMA has asked the agency keep the administrative record for OTC laxatives open until safety studies on both senna and bisacodyl are completed
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