Novartis Transderm Scop comparative claim removed
Executive Summary
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...