Teva Pharmaceutical Industries announced today that
the U.S. Food and Drug Administration (FDA) has accepted for review the
company’s supplemental new drug application (sNDA) for ProAir®
RespiClick (albuterol sulfate) Inhalation Powder 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. ProAir® RespiClick is the only multi-dose,
breath-activated short-acting beta-agonist (SABA) inhaler available to
patients in the U.S. It differs from other currently available rescue
inhalers as it utilizes breath-activated technology that enables
patients to breathe in to receive a measured dose of the medicine,
eliminating the need for hand-breath coordination during inhalation.
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.
