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U.S. Department of Health and Human Services


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FDA Approves Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray

What action is FDA taking today?
FDA is announcing the approval of Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray for “patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.”   Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with COPD breathe better. 

What is Combivent Respimat?
Combivent Respimat is a suitable alternative for patients who are currently using Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol.  Combivent Inhalation Aerosol is being phased out because it contains chlorofluorocarbons (CFCs).  CFCs are chemical compounds that decrease the ozone layer.  As a result, Combivent Inhalation Aerosol will not be available after December 31, 2013. 

Combivent Respimat does not contain CFCs.

Why are CFC inhalers being phased out?
Inhalers that contain CFCs are being phased out due to an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer.  By signing this agreement, the United States promised to make it illegal to make or sell substances that decrease the ozone layer. Most inhalers that contain CFCs have already been phased out as part of this agreement. 

What impact will this have on patients?
Patients who use Combivent Inhalation Aerosol will have another treatment option and a suitable alternative when Combivent Inhalation Aerosol is no longer available.