Anesta Actiq
Executive Summary
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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