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FDA orders HFA-propelled inhalers, bans CFCs


WASHINGTON —The Food and Drug Administration at the end of May issued a public health advisory to alert patients, caregivers and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers given the coming ban on chlorofluorocarbon-propelled inhalers, which no longer will be available in the United States after Dec. 31, 2008. All inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes.

Brought on as the result of the U.S. Clean Air Act and an international treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer, the inhalers are being phased out because they are harmful to the environment and contribute to the depletion of the earth’s ozone layer, which shields the planet from harmful ultraviolet radiation.

While the FDA first began warning patients of the coming change several years ago, the May 30 advisory instructs anyone still using CFC inhalers to ask their doctor about switching now.

“Concern about the environment stimulated the need to phase out CFCs,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers.”

The FDA warns that patients will face a learning curve: HFA inhalers may taste and feel different. The spray may feel softer. Each inhaler must be primed and cleaned in a specific way to prevent clogs. And—at least for now—they tend to cost more because there are no generic versions of them on the market yet.

Sales growth of aerosol beta agonistsSource: IMS Health
Beta agonists, aerosolYear 2007 total $Year 2007 total $ % market share% growth 2007 over 2006
ProAir HFA$396,36836.4%399%
Proventil HFA194,30617.8250
Xopenex HFA145,95813.4149
Ventolin HFA46,9954.3414
Total others50,0734.6–9

Currently, the FDA has approved three HFA-propelled albuterol inhalers: ProAir HFA inhalation aerosol, Proventil HFA inhalation aerosol and Ventolin HFA inhalation aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA inhalation aerosol.

Meanwhile, as the change has been coming for some time now, last year marked a shift in sales to HFA inhalers. Prior to 2007, CFC inhalers were still the No. 1 selling drugs in the beta agonist-aerosol category. According to IMS Health, in 2006, albuterol or CFC inhalers had sales of more than $220 million, versus the HFA-propelled albuterol inhaler ProAir, which generated sales of $79.4 million, during that period. But in 2007, ProAir sales reached almost $400 million versus CFC-propelled albuterol, which ranked second, with sales of more than $255 million, according to IMS Health.

While there still is significant growth expected in the migration from CFC to HFA inhalers, it appears most of the conversion has occurred already. According to Dr. Badrul Chowdhury, director of the FDA’s division of pulmonary and allergy products, approximately 65 percent of inhaler users already have switched to HFA inhalers.

To ensure that the market for CFC inhalers drops off rapidly, Armstrong Pharmaceuticals, the sole remaining maker of CFC inhalers, is expected to stop production even before the Dec. 31 deadline. A spokesman for Armstrong’s parent company wouldn’t say when production would stop, but sales of remaining inventory will continue through the end of the year.

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