September 24, 2008
Teva’s Albuterol Inhaler Wins New Pediatric Indication
Teva Pharmaceutical Industries has announced that the FDA has approved ProAir HFA inhalation aerosol for use in patients as young as four years of age. Previously, ProAir HFA had been indicated for use in patients aged 12 and older.
In clinical studies, ProAir HFA, the albuterol sulfate inhaler, exhibited significant bronchodilator efficacy in pediatric asthmatics aged four to 11 years.
According to the company, 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.
For environmental reasons, the FDA and US Environmental Protection Agency have mandated the transition from chlorofluorocarbon-based albuterol inhalers to HFA albuterol inhalers by the end of 2008.
Mark Salyer, general manager of Teva Specialty Pharmaceuticals, said: "Teva is committed to ensuring a smooth HFA transition and also to providing support for patients using ProAir HFA."