Searle's Cytotec

Executive Summary

FDA's Gastrointestinal Drugs Advisory Cmte. will discuss company's supplemental NDA for Cytotec (misoprostol) for prevention of NSAID-induced peptic ulceration at panel's Sept. 15-16 meeting. While Searle's NDA for short-term treatment of duodenal ulcer, pending since 1984, appears to be hung up, the concomitant use with NSAID's has a 1-A rating at FDA and looks to be moving toward approval. Panel will also review Pharmacia's Dipentum (olsalazine) for prolongation of remission between acute attacks of ulcerative colitis, treatment of mild ulcerative colitis, and as adjunctive therapy for moderate to severe ulcerative colitis.