Executive Summary

C.B. Fleet: FDA needs additional data before it will schedule a "feedback" meeting with the firm on its petition to include two 45 ml doses of dibasic sodium phosphate/monobasic sodium phosphate solution in sequential administration 10-12 hours apart as a bowel cleansing system in the OTC laxative monograph. The agency told Fleet in a July 3 letter that individual subject data for the two abstracts and one unpublished study submitted by the firm "would be required to better evaluate the safety issues related to this sequential bowel cleansing system." The firm filed the petition in March 1993...