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This article was originally published in The Tan Sheet

Executive Summary

CIMETIDINE 200 MG EFFICACY DATA REANALYSIS SHOWS "TRUE ROBUSTNESS" of SmithKline Beecham's two pivotal trials supporting the Rx-to-OTC switch of Tagamet, FDA statistical consultant Ralph D'Agostino, PAD, Boston University, told a joint meeting of the Gastrointestinal Drugs and Nonprescription Drugs Advisory Committees July 27. The statistician, who was the committee reviewer for the switch application, said that after accounting for the potential confounding factors identified at the committees' September 1993 review of OTC cimetidine, "you have statistically significant results" in favor of 200 mg cimetidine versus placebo in the treatment of heartburn.

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