The FDA has approved Ventolin HFA (albuterol sulfate HFA), a new version of the Ventolin metered-dose inhaler (MDI) for asthma and other obstructive lung diseases.
Unlike the currently marketed version of Ventolin, this new inhaler uses an alternative propellant called HFA (hydrofluoroalkane) to propel medication rather than ohlorofluorocarbons (CFCs). GlaxoSmithKline, Research Triangle Park, N.C., manufactures both Ventolin products.
The approval of Ventolin HFA means that there are now two albuterol HFA MDIs approved for use in the United States. The first, Proventil HFA, marketed by Key Pharmaceuticals of Kenilworth, N.J., was approved in 1996. The availability of the two albuterol HFA MDIs offers patients important alternatives to their present albuterol CFC medications.
Since 1978, the use of CFC-propelled aerosol products in this country has been sharply reduced because of increasing evidence that CFCs contribute to the depletion of the Earth's protective ozone layer.
With time, it is expected that these and other CFC-free alternatives will prove to be fully acceptable replacements for the current CFC products, allowing for eventual removal of albuterol CFC MDIs from the market. The removal would occur through a process of public rulemaking, allowing patients, doctors, and others to provide input before the agency takes any actions.
COPYRIGHT 2001 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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