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Advair faces committee review

Executive Summary

The Pulmonary-Allergy Drugs Advisory Committee will convene May 1 to discuss efficacy data from GlaxoSmithKline's sNDA for the approved long-acting beta agonist bronchodilator Advair Diskus (fluticasone propionate/salmeterol). Indicated for the treatment of asthma and chronic obstructive pulmonary disease associated with chronic bronchitis, GSK is seeking expanded labeling that includes data from a 6,100-patient study showing increased survival and reduced exacerbations in COPD patients. GSK is also seeking approval of Advair 500/50 for COPD; the current COPD indication is for Advair 250/50...

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