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AstraZeneca/Avillion Asthma Combo Draws Split Decision At FDA Panel; Data Was ‘All Over The Place’

Executive Summary

In near unanimous votes, advisory committee rejects budesonide/albuterol sulfate fixed-dose combination for young children but favors approval for adults; the vote in adolescents was more divided, with some panelists believing extrapolation of adult efficacy data were appropriate for this population.

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