FDA Advisory Committee recommends continued availability of Serevent for treatment of asthma

Main Category: Respiratory / Asthma
Article Date: 20 Jul 2005 - 0:00 PDT

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An advisory panel to the US Food and Drug Administration met today to discuss the safety of long-acting beta2-agonists. The panel voted unanimously that GlaxoSmithKline's salmeterol, an active ingredient in Serevent® (salmeterol xinafoate) and Advair Diskus ® (fluticasone propionate and salmeterol xinafoate), should remain available for patients, recognizing their role as important treatment options for asthma.

Comprehensive data for Serevent, a highly effective bronchodilator used to treat asthma, shows that the drug continues to exhibit a favorable benefit-to-risk profile.

"Patients should be reassured that Serevent and Advair® will continue to be available for the treatment of asthma," said Dr. Kathy Rickard, GSK Vice President, Clinical Development and Medical Affairs, respiratory medicine in the U.S. "Serevent is one of the most extensively studied products for asthma treatment in the world and we remain committed to continuing research."

About Serevent:

Serevent Diskus is indicated for long-term twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting beta2-agonist. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists.

About Advair:

Advair Diskus is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 4 years of age and older. Advair Diskus is NOT indicated for the relief of acute bronchospasm.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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