Merck's Prilosec

Executive Summary

Company confirmed in a Jan. 11 release that it has received an "approvable" letter from FDA covering expanded use of the anti- ulcer drug Prilosec (omeprazole) and that Merck "is in discussion with the agency as to the extent of the new claims." Merck was notified by FDA Dec. 26 that Prilosec is approvable for short-term treatment of active duodenal ulcers poorly responsive to customary medical treatment ("The Pink Sheet" Jan. 7, "In Brief"). Merck said in the release that the approvable letter from FDA "contained an expanded indication that is narrower than that originally recommended in May 1990 by an FDA advisory committee. Merck has not accepted the narrower version and is discussing final language with FDA. Rumors emanating from Europe about Merck withdrawing the application are totally unfounded." Prilosec is approved in the U.S. for treatment of Zollinger-Ellison syndrome and gastroesophageal reflux disease.