WASHINGTON (CN) – Armstrong Pharmaceuticals has been given the go-ahead to produce or import 30 metric tons of chlorofluorocarbons CFC-11, CFC-12 and CFC-114 for use in metered dose inhalers, according to an Environmental Protection Agency rule.
Armstrong, the maker of asthma relief medication Primatine Mist, is the only company allowed to import these “Class I ozone-depleting substances” for 2010. The EPA classifies the use of Chlorofluorocarbons in Armstrong inhalers to be an essential use, meaning that a substitute has not been found.
Essential use regulations came about through the signing of the Montreal Protocol, an international treaty designed to protect the ozone by phasing out the production of a number of substances believed to be responsible for its depletion.
The Food and Drug Administration, earlier this year, removed the essential-use designation from the medications flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Makers of those medications may no longer use chlorofluorocarbons to make the medication spray out of its container. The FDA found no substantial technical barriers to formulating these products without using the ozone-depleting substance, and its use will be phased out between June 2010 and December 2013.
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