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Bayer/GSK vardenafil “approvable”

Executive Summary

FDA "approvable" letter for Bayer/GSK's erectile dysfunction drug vardenafil requests "additional short-term clinical pharmacology studies," GSK Chief Operating Officer Robert Ingram tells analysts during July 24 earnings call. The company now projects a launch in the U.S. in 2003. The delay tightens up the race to launch the next erectile dysfunction agent; Lilly/Icos' Cialis is delayed due to manufacturing problems (1"The Pink Sheet" July 22, p. 10). GSK said the brand name Nuviva is no longer under consideration for vardenafil...
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