Tagamet Rx-to-OTC switch
This article was originally published in The Tan Sheet
Executive Summary
FDA's Gastrointestinal Drugs and Nonprescription Drugs Advisory Committees will meet in joint session July 27 to discuss SmithKline Beecham's switch application for Tagamet (cimetidine) as a treatment for episodic heartburn. The two committees initially reviewed the application in September 1993 and determined that the data in the company's NDA did not support the effectiveness of the OTC dose ("The Tan Sheet" Sept. 13, p. 1). The meeting begins at 9 a.m. in Conference Rooms D & E of FDA's Parklawn Building, 5600 Fishers Lane, Rockville, Md