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Monday, October 28, 2013

FDA SAYS WILL COMPLETE PHASE-OUT OF INHALER PRODUCTS CONTAINING CHLOROFLUOROCARBONS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, which contribute to ozone depletion.

While most inhaler products containing CFCs have already been phased out by the FDA, two products currently remain on the market: Combivent Inhalation Aerosol and Maxair Autohaler. However, these products will no longer be available after the end of this year. People with asthma or chronic obstructive pulmonary disease (COPD) who use these inhalers should talk to their health care professional about a prescription for an alternative treatment.

Inhalers are critical products for those persons suffering from asthma or COPD. In the United States, more than 25 million people suffer from asthma, a disease that affects the airways in the lungs and can cause coughing, trouble breathing, wheezing and tightness or pain in the chest. Additionally, 15 million people have been diagnosed with COPD, a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm.