Merck's Losec (omeprazole)
Executive Summary
Merck's Losec (omeprazole): March 15 meeting of FDA's Gastrointestinal Drugs Advisory Committee expected to consider long-term once-a-day use of 60 mg omeprazole for Zollinger Ellison Syndrome and for short-term use (four weeks or less) of 40 mg and 20 mg, respectively, in reflux esophagitis and duodenal ulcer. Losec, licenced from Astra, is the first proton pump inhibitor. The Losec NDA was filed in December 1987; the product has been in clinical development for almost a decade.
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