FDA accepts label expansion application for ProAir RespiClick (albuterol sulfate) inhalation powder in bronchospasm-Teva Pharmaceutical
The FDA has accepted for review the supplemental new drug application (sNDA) for ProAir RespiClick (albuterol sulfate) Inhalation Powder, from Teva Pharmaceutical, for the treatment or prevention of bronchospasm in patients 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB).
ProAir RespiClick was approved by the FDA in March 2015 for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and for the prevention of EIB. The sNDA for ProAir RespiClick includes data from Teva’s pediatric clinical trial program that evaluated the safety and efficacy of the treatment in children 4 – 11 years of age. The sNDA for ProAir RespiClick has been accepted by the FDA for standard review, with FDA Regulatory Action expected in April 2016.
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