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Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available

April 13, 2010

SILVER SPRING, Md., April 13 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The affected products and their phase out schedule include:


                           Last Date to be
                           manufactured, sold or
    Inhaler Medication     dispensed in U.S.      Manufacturer
    Tilade Inhaler
     (nedocromil)         June 14, 2010           King Pharmaceuticals
    Alupent Inhalation
     Aerosol                                       Boehringer Ingelheim
     (metaproterenol)     June 14, 2010            Pharmaceuticals
    Azmacort Inhalation
     Aerosol
     (triamcinolone)      Dec. 31, 2010           Abbott Laboratories
    Intal Inhaler
     (cromolyn)           Dec. 31, 2010           King Pharmaceuticals
    Aerobid Inhaler
     System
     (flunisolide)        June 30, 2011           Forest Laboratories
    Combivent Inhalation
     Aerosol (albuterol
     and ipratropium in                            Boehringer Ingelheim
     combination)         Dec. 31, 2013            Pharmaceuticals
    Maxair Autohaler                               Graceway
     (pirbuterol)         Dec. 31, 2013            Pharmaceuticals

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun’s harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

“During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA’s Center for Drug Evaluation and Research. “We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them.”

The CFC phase out is part of an international agreement to ban substances that deplete the Earth’s ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

The decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

For more information:

Seven Inhalers That Use CFCs Being Phased Out

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm207864.htm

Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm193896.htm

Metered-Dose Inhalers Clean Air Act Information

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm071523.htm

Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm082370.htm

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


Source: newswire



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