SmithKline Beecham's Tagamet
This article was originally published in The Tan Sheet
Executive Summary
"There is a chance" that the Rx-to-OTC switch application could be approved based on available date, SmithKline Beecham CEO Robert Bauman told the Bear Sterns Health Care Conference Sept. 20 in New York City. Bauman noted that during the advisory committee review of the cimetidine switch application, "we did not have sufficient numbers to prove effectiveness in one day usage" ("The Tan Sheet" Sept. 13, p. 1). The company is "working with [FDA] to see if we can find additional data and additional ways to look at it . . . to see if we can demonstrate that effectiveness. I think there is a belief by them and everyone that Tagamet is going to be effective," he maintained. "If we must go back and do additional trials in order to support the effectiveness . . . then it will obviously take longer for approval".
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