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Novartis labeling changes

This article was originally published in The Tan Sheet

Executive Summary

Labeling of firm's Transderm Scop Rx motion sickness patch modified to remove statement claiming superiority over Pharmacia's OTC remedy Dramamine (oral dimenhydrinate), according to FDA's May 10 letter responding to Pharmacia petition. Agency determined comparative statement "is not supported by any data in Novartis' [NDA] for Transderm Scop," and requested it be removed from labeling. Novartis complied in a labeling supplement approved March 22. Novartis also removed superiority claim from DTC print ads, Web site after National Advertising Division determined evidence was insufficient to support the statement (1"The Tan Sheet" Nov. 13, 2000, p. 11)...

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