Teva Announces FDA Approval of ProAir RespiClick® (albuterol sulfate) Inhalation Powder for Patients with Pediatric Asthma


Apr. 29, 2016

Teva Pharmaceutical Industries Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick® (albuterol sulfate) Inhalation Powder for treating or preventing bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and also for preventing exercise-induced bronchospasm (EIB).

In March 2015, ProAir RespiClick® was approved by the FDA for use in patients 12 years of age and older. It remains as the only multi-dose, breath-activated, dry powder, short-acting beta-agonist (SABA) inhaler available in the U.S.

“The prevalence of childhood asthma in the U.S. is high, at more than six million patients, and that number continues to rise. For this young population of asthma patients, learning to use inhalers properly can be quite challenging. Thus, the pediatric indication for ProAir RespiClick® is important as it represents a new rescue inhaler option for younger patients that eliminates the need for hand-breath coordination during inhalation and was designed to be used without a spacer,” said Dr. Erwin Gelfand, Chairman,Department of Pediatrics at National Jewish Health.

As said by Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development: “We are very pleased with the FDA’s decision to expand the indication of ProAir RespiClick® for the treatment of patients as young as four years of age. The availability of this treatment option for younger patients is a demonstration of Teva’s commitment to optimizing respiratory therapies through the development of new delivery systems that help address needs in the marketplace.”


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