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Novartis Transderm Scop Superiority Claim Disputed By Pharmacia In Petition

Executive Summary

Pharmacia is requesting that FDA modify the physician package insert for Novartis' Transderm Scop motion sickness patch to remove a statement claiming superiority to OTC oral dimenhydrinate.

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Novartis Transderm Scop comparative claim removed

Novartis relabels its Rx motion sickness product Transderm Scop (transdermal scopolamine) to remove language that the drug "provided significantly greater protection than that obtained with oral dimenhydrinate." Pharmacia, which markets OTC dimenhydrinate as Dramamine, petitioned for the removal (1"The Pink Sheet" April 16, 2001, p. 28). "FDA evaluated this statement and determined that it is not supported by any data" in the Transderm Scop NDA and asked Novartis to remove the language, agency says...

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