Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

May 29, 2003

Briefing Information

Alfuzosin and Vardenafil


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

FDA Background Package: Alfuzosin HCI (extended release ER) Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia; and Vardenafil HCI Treatment of Erectile Dysfunction (HTM) (PDF) (Word)

FDA Background Package: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs, Preliminary Concept Paper (HTM) (PDF) (Word)

Alfuzosin Briefing Package, Sanofi-Synthelabo (HTM) (PDF) (Word)

Sanofi-Synthelabo SL77.0499-10 (Alfuzosin) Bibliography (HTM) (PDF) (Word)

Levitra® (Vardenafil HCI) Briefing Document, Assessment of the QT Prolongation Potential of the Phosphodiesterase-5 Inhibitor Vardenafil, Bayer and GlaxoSmithKline (PDF)

Bibliography, Bayer and GlaxoSmithKline (PDF)

Open Public Hearing

Overview of Relevant Sildenafil Data, Absence of Adverse Outcomes Potentially Related to QT Prolongation - 5 Years of Post-Marketing Experience, Executive Summary, Pfizer (PDF)