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Levitra, UroXatral QT prolongation

Executive Summary

QT prolongation associated with Bayer/GlaxoSmithKline's erectile dysfunction therapy Levitra and Sanofi-Synthelabo's benign prostatic hyperplasia agent UroXatral will be discussed by FDA's Cardiovascular & Renal Drugs Advisory Committee on May 29. Levitra (vardenafil) has been "approvable" at FDA since July 2002 and was recently approved in Europe ("The Pink Sheet" March 17, p. 6). UroXatral has been "approvable" at FDA since October 2001 [To watch a webcast or video of this meeting, go to FDAadvisoryCommittee.com]...
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PS041570

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