Child perception studies demonstrating that "children did not perceive the drug as candy" were conducted to assuage FDA concern about risk management outlined in Nov. 13, 1997 non-approvable letter, Anesta Chairman William Moeller reports. In a previous study of 200 children up to 51 months of age, only two were able to open Actiq packaging ("The Pink Sheet" Sept. 29, 1997, T&G-3). An NDA amendment and revised risk management plan were submitted to FDA May 5, and company expects approval in November. Abbott will co-promote product with 40 sales reps, Anesta with six
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