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FDA approves albuterol inhalation aerosol asthma therapy in children aged 4 to 11 years
Monday, October 06 2008 | Comments
What's This?
The Food and Drug Administration approved albuterol sulfate inhalation aerosol (ProAir HFA; Teva Pharmaceutical Industries Ltd.) as a treatment for asthma in children aged 4 to 11 years.Previously, the compound was only indicated for use in patients aged at least 12 years.
Approval for the new indication was supported by clinical trials in which albuterol sulfate inhalation aerosol 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. CFC-propelled albuterol inhalers are being phased out because they harm the environment by contributing to depletion of the ozone layer.
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