Merck's Prilosec

Executive Summary

Is "approvable" for use in the short-term treatment of active duodenal ulcer poorly responsive to customary medical therapy. Merck reportedly received the approvable letter Dec. 26. An FDA advisory committee recommended approval for treatment of short- term acute and refractory duodenal ulcers in May 1990. The acid pump inhibitor was approved in 1989 for three limited indications: short-term treatment of severe erosive esophagitis, short-term treatment of symptomatic gastroesophageal reflux disease poorly responsive to customary medical treatment, and long-term treatment of Zollinger-Ellison syndrome.