Teva announced that the Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate inhalation powder), the first breath-actuated dry-powder inhaler approved for acute asthma symptoms.
ProAir RespiClick is indicated for the treatment or prevention of bronchospasm in patients ≥12 years old with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm (EIB) in patients ≥12 years old. Albuterol sulfate is a beta2-adrenergic agonist that activates beta2-adrenergic receptors on airway smooth muscle.
The FDA approval was based on data from eight clinical trials designed to evaluate the safety and efficacy of ProAir RespiClick in adults and adolescents with asthma and EIB. Study findings showed that ProAir RespiClick was safe and effective with adverse events consistent with those seen with previous albuterol inhalers.
ProAir RespiClick will be available as a dry-powder inhaler containing 200 actuations and 0.65g of the formulation. Each dose delivers 108mcg of albuterol sulfate (equivalent to 90mcg of albuterol base). It is expected to launch on April 27, 2015.
For more information call (888) 482-9522 or visit TevaUSA.com.