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Bayer/GSK vardenafil "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA deems Bayer/GlaxoSmithKline's erectile dysfunction drug vardenafil "approvable" July 23, requesting additional short-term clinical pharmacology studies for the phosphodiesterase-5 inhibitor. The approvable decision, coming 10 months after the Sept. 25, 2001 NDA submission, pushes back the projected launch date from second-half 2002 to 2003. The launch of Lilly/ICOS' competing ED therapy, Cialis (tadalafil), also has been delayed - to the second half of 2003. FDA similarly requested pharmacology studies from Lilly/ICOS in an April 29 "approvable" letter (Pharmaceutical Approvals Monthly, May 2002, In Brief

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