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From The Quarterly Conference Calls....

Executive Summary

Advair for COPD: GSK hopes to receive approval of Advair (fluticasone/salmeterol) for chronic obstructive pulmonary disease in "a few months," CEO J.P. Garnier tells April 24 conference call. Although an FDA advisory committee "was unabashedly in favor" of the new indication, the agency "asked us for some data and we have now supplied the data.... I don't expect this to come to a fast resolution." FDA approved only the NDA for salmeterol (Serevent) for the COPD claim (1"The Pink Sheet" April 1, p. 27)....Off-label use likely: While the Advair COPD indication has hit a snag at FDA, "there is use in the medical community," Garnier notes. "This is not encouraged. It just happens with specialists who have experience with Advair in COPD. We're getting good reports. We're trying to manage this as best we can"...
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