FDA Approves New Pediatric Use for ProAir RespiClick
Teva announced that the Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in children aged 4–11 years with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB).
In March 2015, ProAir RespiClick was approved for use in patients aged ≥12 years. The expanded indication provides an option for younger patients because ProAir RespiClick does not require hand-breath coordination during inhalation and also eliminates the need for a spacer.
The FDA approval was based on data from a Phase 3 clinical trial program that assessed the safety and efficacy of treatment in patients with asthma as young as 4 years old. Study data showed treatment with ProAir RespiClick led to significantly greater improvement in forced expiratory volume (FEV1) vs. placebo.
ProAir RespiClick is a breath-activated, multi-dose, dry powder, short-acting beta-agonist (SABA) inhaler. It delivers 108mcg of albuterol sulfate (equivalent to 90mcg of albuterol base) per actuation. Each inhaler is supplied for 200 actuations.
For more information call (888) 482-9522 or visit MyProAir.com.