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FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients With COPD
Date:4/30/2008

Advair 250/50 Now the Only Treatment Approved to Both Reduce Exacerbations

and Improve Lung Function

RESEARCH TRIANGLE PARK, N.C., April 30 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration today approved Advair Diskus(R) 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. With this approval, Advair becomes the only treatment FDA has approved to reduce COPD exacerbations. Treatment guidelines for COPD state that the reduction of exacerbations is a key goal in managing the disease.

COPD is a progressive, life-threatening lung disease that includes chronic bronchitis, emphysema or both. Exacerbations are flare-ups or episodes of worsening COPD symptoms that often require additional treatment, such as antibiotics, oral corticosteroids and in some cases hospitalization. Symptoms may include coughing, shortness of breath, or coughing up excess mucus beyond normal day-to-day variations. Seventy-seven (77) percent of patients with COPD report experiencing at least one exacerbation within the past year.

"This is good news for my patients with COPD because Advair now brings an additional benefit in managing their disease," said Gary Ferguson, MD, Pulmonary Research Institute of Southeast Michigan. "My goal as a physician is to help reduce the number of exacerbations my patients experience and Advair 250/50 will be a critical treatment in helping meet that goal."

The FDA also expanded the use of Advair Diskus 250/50 to a broader patient population which includes not only patients with COPD associated with chronic bronchitis, but also emphysema or both conditions. Advair 250/50 is the only approved strength for COPD in the U.S., because an efficacy advantage of the higher strength over Advair 250/50 has not been demonstrated.

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SOURCE GlaxoSmithKline
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