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.
You may also be interested in...
Allegra DTC Ads Include Comparative Claims Against Zyrtec, OTCs
Aventis is running direct-to-consumer television ads for Allegra highlighting its non-sedating profile in comparison to other prescription and over-the-counter antihistamines
Allegra DTC Ads Include Comparative Claims Against Zyrtec, OTCs
Aventis is running direct-to-consumer television ads for Allegra highlighting its non-sedating profile in comparison to other prescription and over-the-counter antihistamines
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...