FDA report doubts need for Advair approval at higher doses

04/28/2007 | MarketWatch · Wall Street Journal, The

An FDA report in advance of a Tuesday advisory committee meeting casts doubt on whether higher doses of Advair should be approved to treat patients with chronic obstructive pulmonary disease to increase survival and reduce exacerbations. GlaxoSmithKline's Advair already is approved as an asthma treatment and to treat COPD patients at 250/50 microgram doses, but GSK wants clearance at 500/50 microgram doses.

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