RESEARCH TRIANGLE PARK, N.C., Feb. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that Flovent(R) HFA (fluticasone propionate HFA) Inhalation Aerosol, a reformulated version of the asthma medication Flovent(R) (fluticasone propionate) Inhalation Aerosol, will become available in pharmacies on March 1. Flovent HFA will replace Flovent Inhalation Aerosol, which used chlorofluorocarbon (CFC) to propel the medication out of the canister and into the lungs. The new formulation uses a more ozone friendly propellant, hydrofluoroalkane (HFA-134a).
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With the introduction of Flovent HFA and the phase-out of the CFC- containing Flovent product, GlaxoSmithKline will successfully complete the transition of its respiratory products to CFC-free formulations. "We are very proud to be the first company in the U.S. to achieve the transition of our asthma and COPD medicines to CFC-free formulations," said Stan Hull, senior vice-president, GlaxoSmithKline. "This has been a significant undertaking, involving substantial work and resources, but we're pleased to achieve our goal of a 100% CFC-free portfolio without disrupting patient access to these very important medicines."
Leading the Way to Environmentally Friendly Products
In 1987, environmental concerns led to an international agreement called the Montreal Protocol that provided for the phase-out of CFCs, which have been shown to damage the earth's protective ozone layer. Medical products that are considered essential, such as asthma inhalers, are temporarily exempt from the CFC ban but only until ozone friendly alternatives become available. Consistent with the objectives of the Montreal Protocol, GlaxoSmithKline is committed to phasing-out ozone-depleting substances as soon as possible.
Over the past two decades, GlaxoSmithKline has invested hundreds of millions of dollars in its efforts to develop effective alternatives to CFC formulations. These efforts included the development of alternative delivery systems, including HFA and dry powder formulations; modification of manufacturing facilities to accommodate the production of new devices; and, clinical trial programs for new formulations.
Flovent HFA is the last in the GlaxoSmithKline portfolio of respiratory products to be transitioned to a CFC-free reformulation in the United States. Similar transitions occurred for Ventolin (albuterol sulfate inhalation aerosol), a short-acting bronchodilator, and Serevent (salmeterol xinafoate inhalation aerosol), a long-acting bronchodilator, in 2002 and 2003 respectively.
Flovent HFA
Flovent is an inhaled corticosteroid that helps to reduce inflammation in the airways -- one of the main components of asthma. Flovent HFA was approved by the Food & Drug Administration in May 2004 and is indicated for the maintenance treatment of asthma as a preventative therapy in patients 12 years of age and older. Flovent is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirements for oral corticosteroids over time. Adrenal insufficiency may occur when transferring patients from systemic steroids to inhaled steroids. Flovent does not replace fast-acting inhalers for sudden symptoms.
In clinical trials of adults and adolescents, Flovent HFA demonstrated comparable safety and efficacy to the CFC Flovent product. For both formulations, most adverse events were mild to moderate in severity, and the most common side effects were upper respiratory tract infection, headache, throat irritation, and sinusitis.
With the introduction of Flovent HFA, the CFC formulation of Flovent will be phased out of distribution by mid-March 2005.
Flovent HFA was developed and is marketed by GlaxoSmithKline, a research- based pharmaceutical company and a world leader in respiratory care. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, please visit the company's website at http://www.gsk.com/.
Contact Patty Johnson or Lisa Behrens at 919-483-2839 for full prescribing information.
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