Tagamet OTC switch
Executive Summary
FDA's Gastrointestinal Drugs and Nonprescription Drugs Advisory Committees will meet in a joint session July 27 to discuss an Rx-to-OTC switch application for SmithKline Beecham's Tagamet (cimetidine) to treat episodic heartburn. The two committees initially reviewed the application in September 1993 and determined that data did not support the effectiveness of the OTC dose. The meeting begins at 9 a.m. in conference rooms D&E of FDA's Parklawn Building