Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 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 for use in patients 12 years of age and older in March 2015 and remains the only breath-activated, multi-dose, dry powder, short-acting beta-agonist (SABA) inhaler available in the U.S.
The pediatric approval of ProAir RespiClick® comes after the FDA’s review of data from Teva’s Phase III clinical trial program that evaluated the safety and efficacy of the treatment in patients as young as four years of age, living with asthma. The data demonstrated that treatment with ProAir RespiClick® resulted in significantly greater improvement in forced expiratory volume (FEV1) compared to placebo. The most common adverse events associated with treatment with ProAir RespiClick® included upper respiratory infections, mouth and throat pain and vomiting.
