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|April 29, 2016 8:01 a.m.|
|Teva Announces FDA Approval of ProAir RespiClick® (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11|
New Pediatric Indication Provides Treatment Option for Children that Eliminates Need for Spacer and Hand-Breath Coordination During Inhalation
ProAir RespiClick® was approved by the
“The prevalence of childhood asthma in the U.S. is high, at more than
six million patients, and that number continues to rise,” said Dr.
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.
“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,” said
ProAir RespiClick® (albuterol sulfate) Inhalation Powder is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Important Safety Information
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company’s respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.
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This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of
Teva Pharmaceutical Industries Ltd.: