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FDA mandates switch to HFA inhalers

5/30/2008

WASHINGTON The Food and Drug Administration today issued a public health advisory to alert patients, caregivers and healthcare professionals to switch to hydrofluoroalkane propelled albuterol inhalers because chlorofluorocarbon propelled inhalers will not be available in the U.S. after Dec. 31, 2008. CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth’s surface.

“Concern about the environment stimulated the need to phase out CFCs,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers.”

Currently, the FDA has approved three HFA-propelled albuterol inhalers: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

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