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FDA approves Teva's ProAir HFA inhalation aerosol asthma therapy in children aged 4 to 11 years
Wednesday, September 24 2008 | Comments
What's This?
The Food and Drug Administration approved Teva Pharmaceutical Industries Ltd.'s ProAir HFA (albuterol sulfate) inhalation aerosol as a treatment for asthma in children aged 4 to 11 years. Previously, ProAir HFA was only indicated for use in patients aged 12 years or older.
Approval for the new indication was supported by clinical trials in which ProAir HFA exhibited significant bronchodilator efficacy in children aged 4 to 11 years.
Last May the FDA issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. As previously reported, CFC-propelled albuterol inhalers are being phased out because they harm the environment by contributing to depletion of the ozone layer.
"Teva is committed to ensuring a smooth HFA transition and also to providing support for patients using ProAir HFA," said Mark Salyer, a general manager at Teva Specialty Pharmaceuticals.
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