Avillion/AstraZeneca’s Budesonide/Albuterol Combo For Asthma Has ‘Uncertain’ Pediatric Benefit
US FDA is asking an advisory committee whether extrapolation of adult data is appropriate to bridge uncertainties in efficacy for asthma patients under age 18 years; metered-dose inhaler would be the first combination product approved in the US containing an inhaled corticosteroid and a short-acting beta2-adrenergic agonist.
