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FDA approves replacement for combination inhaler
Medpage Today
WASHINGTON — The US Food and Drug Administration (FDA) has granted approval for an ipratropium bromide and albuterol sulfate inhalation spray (Combivent Respimat Inhalation Spray, Boehringer Ingelheim) for patients with chronic obstructive pulmonary disease (COPD) who use a regular aerosol bronchodilator, but continue to have evidence of bronchospasm and require a second bronchodilator.
This combination inhaler is considered to be a suitable alternative for patients who are currently using ipratropium bromide and albuterol sulfate (Combivent Inhalation Aerosol), which will soon be unavailable. The aerosol product is being phased out, as it contains chlorofluorocarbons (CFCs), and will be removed from the market after December 31, 2013.
The replacement drug has the same active ingredients as the drug being phased out, but will not have the aerosol propellent.
Last April, the FDA announced that will it phase out 7 different metered dose inhalers that contain CFCs that are used to treat patients with asthma, COPD, or both. The reason for the phase out of CFC inhalers is the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement that the United States signed, along with most other countries. CFCs, along with other substances, cause harm to the environment by decreasing the ozone layer, and signatories to the agreement promised to remove these agents from the marketplace after designated dates. Most CFC inhalers have already been phased out as part of this protocol.
