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Tagamet Rx-to-OTC switch

This article was originally published in The Tan Sheet

Executive Summary

Aug. 25 Federal Register notice announces a Sept. 9 joint meeting of FDA's OTC Drugs and Gastrointestinal Drugs Advisory Committees to review SmithKline's NDA requesting marketing approval of an OTC version of the prescription antiulcer drug Tagamet (cimetidine) for episodic heartburn relief ("The Tan Sheet" May 31, p. 1). SmithKline's original NDA also included an indication for nocturnal heartburn relief but the company has elected to pursue one indication for the time being following discussions with FDA. Meeting begins 8:30 a.m. in conference rooms D and E of FDA's Parklawn Building. . . .

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