FDA Approves an inhalation aerosol in patients with COPD

The U.S. Food and Drug Administration (FDA) has granted approval to an aerosol by inhalation of ipratropium bromide and albuterol sulfate       ( Combivent Inhalation Spray Respimat , Boehringer Ingelheim) in patients with chronic obstructive pulmonary disease (COPD) who used a bronchodilator aerosol suspension, but still have signs of bronchospasm and requires a second bronchodilator.

It is considered that the combination inhaler is an appropriate alternative in patients who are currently using ipratropium bromide and albuterol sulfate ( Combivent Inhalation Aerosol ), which soon will retire from the trade. The aerosol suspension product is gradually being withdrawn because it contains chlorofluorocarbons (CFCs) and trade will be removed after December 31, 2013.

In April, the FDA announced that phase out seven different dosimetric inhalers containing CFCs which are used to treat patients with asthma, COPD, or both. The reason for the phasing out of CFC inhalers is the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement signed United States, along with most other countries. Chlorofluorocarbons, like other substances, damage to the environment by reducing the ozone layer and the signatories of the agreement are committed to remove these compounds from trade after the designated dates. Most inhalers containing CFCs have been phased out as part of this protocol.

Aerosol dispensers Phasing

The general use of CFCs in consumer aerosols was banned for decades in the United States eliminated the production of CFCs from January 1, 1996, except for certain limited uses, such as aerosol dispensers.

Badrul Chowdhury Dr, PhD, director of the Division of Pulmonary Products, Allergy and Rheumatology, Center for Drug Evaluation and Research, FDA, said in a statement: "During this transition, the FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD. "

Currently we are working with professional associations and patient organizations to make sure they know which products are no longer available and have information regarding which alternative medication might work better. "

The decision to remove these products is the latest in a series of decisions concerning the withdrawal of trade in CFC inhalers, as forcing the Clean Air Act. The FDA proposed to phase out the remaining seven products in 2007 and reached its final decision after reviewing more than 4000 public comments and information that was sent as part of a public meeting.

The aerosol inhaler containing ipratropium bromide and albuterol sulfate combined, which is produced by Boehringer Ingelheim Pharmaceuticals, will provide patients with COPD and another treatment option when a suitable alternative is not available in aerosol suspension.

Author: Roxanne Nelson