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FDA Approves CFC-Free Inhaler for COPD


 

An inhalation spray containing ipratropium bromide and albuterol sulfate had been approved for patients with chronic obstructive pulmonary disease, according to a statement issued Oct. 7 by the Food and Drug Administration.

The product, marketed as Combivent Respimat inhalation spray, does not contain chlorofluorocarbons (CFCs) and "is a suitable alternative for patients who are currently using Combivent (ipratropium bromide and albuterol sulfate) inhalation aerosol," according to the statement, issued by the Division of Drug Information (DDI) in the FDA’s Center for Drugs, Evaluation and Research (CDER). Combivent inhalation aerosol, which contains CFCs, will not be available after Dec. 31, 2013. Like other inhalers that contain CFCs that deplete the ozone layer, the inhaler is being phased out because of the Montreal Protocol on Substances that Deplete the Ozone Layer, which makes it illegal to sell or make substances that decrease the ozone layer.

Ipratropium is an anticholinergic bronchodilator, and albuterol is a selective beta 2 adrenergic bronchodilator. Combivent inhalers are indicated for people with COPD, on a regular bronchodilator, who continue to have evidence of bronchospasm and who require a second bronchodilator.

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