FDA Approves Inhalation Spray for COPD

Roxanne Nelson

October 07, 2011

October 7, 2011 — 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.

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.

Phase Out of MDIs

The general use of CFCs in consumer aerosols has been banned for decades, and production of CFCs in the United Sates was eliminated as of January 1, 1996, except for certain limited uses, such as in metered-dose inhalers.

"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, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, in a statement. "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 decision to phase out these 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 FDA proposed to phase out the 7 remaining products in 2007, and reached their final decision after reviewing more than 4000 public comments and information that were submitted as part of a public meeting.

The combination ipratropium bromide and albuterol sulfate inhalation spray, which is manufactured by Boehringer Ingelheim Pharmaceuticals, will give COPD patients another treatment option and a suitable alternative when the inhalation aerosol is no longer available.


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