Anesta Actiq
Executive Summary
Company files amendment to NDA May 4 for oral transmucosal fentanyl citrate in the treatment of chronic pain. The amendment contains a reanalysis of the adverse events and dosing profiles data, more information on stability and packaging, and an expansion and clarification of Anesta's proposed risk-management plan. Anesta received a "not approvable" letter in November for the NDA submitted a year earlier ("The Pink Sheet" Nov. 24, 1997, T&G-11)