FOOD AND DRUG ADMINISTRATION

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

October 4, 2001

Slides

NDA 21-266, Vfend(voriconazole) Tablets, and NDA 21-267, Vfend™ I.V. (voriconazole) for infusion, Pfizer Global Research and Development

Proposed for the treatment of invasive aspergillosis, serious Candida infections, infections caused by Scedosporium spp. and Fusarium spp., rare and refractory infections and empirical treatment of febrile neutropenia.

Sponsor Presentation Pfizer Global Research & Development   

Disclaimer

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.

Main Presentation, Reinhard Baildon, MD   ppt   html

Thomas Patterson, MD   ppt  html

Main Efficacy, Helen Whamond Boucher, MD   ppt   html

FDA Presentation, Rosemary Tiernan MD    ppt   html

Empiric Antifungal Therapy of Febrile Neutropenic Patients, John H Powers MD   ppt   html

Questions   ppt   html