Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration (FDA) has approved ProAir HFA (albuterol sulfate) Inhalation Aerosol for use in patients as young as 4 years of age. Previously, ProAir HFA had been indicated for use in patients aged 12 and older.
ProAir HFA (albuterol sulfate) Inhalation Aerosol 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.
In clinical studies, ProAir HFA, the market leading albuterol sulfate inhaler, exhibited significant bronchodilator efficacy in paediatric asthmatics aged 4 to 11 years. ProAir HFA provides physicians with a treatment option to help relieve children's asthma symptoms as they occur wherever they occur, which is especially important as children return to school. With asthma affecting more than one child in every 20 in the United States, studies show that asthma emergency room and hospitalization rates spike in September.
For environmental reasons, the FDA and US Environmental Protection Agency (EPA) have mandated the transition from chlorofluorocarbon (CFC)-based albuterol inhalers to HFA albuterol inhalers by the end of this year. "Teva is committed to ensuring a smooth HFA transition and also to providing support for patients using ProAir HFA," said Mark Salyer, general manager, Teva Specialty Pharmaceuticals.
Teva has been providing doctors and patients with a variety of educational and cost saving tools to help educate and increase access to ProAir.
Teva Specialty Pharmaceuticals-USA is the US-based respiratory division of Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company.