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FDA APPROVES FLOVENT HFA FOR USE IN CHILDREN

March 27, 2006

GlaxoSmithKline has received FDA approval to use its asthma treatment Flovent HFA in children ages 4 to 11, the company said.

Flovent HFA (fluticasone propionate) is an inhaled corticosteroid that helps prevent airway inflammation associated with asthma. The product is a reformulation of the asthma drug Flovent Inhalation Aerosol, which contained chlorofluorocarbon (CFC) propellants. Flovent HFA, by contrast, uses hydrofluoroalkane to propel the medication into the lungs and is more ozone friendly.

Flovent HFA was first approved by the FDA in May 2004 for patients age 12 and older. Flovent HFA is also indicated for patients requiring oral corticosteroid therapy for asthma. Nine million children under the age of 18 have been diagnosed with asthma, and 3.6 million of those children are between the ages of 5 and 11, according to the U.S. Centers for Disease Control.