FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

Antiviral Drugs Advisory Committee

 

DRAFT AGENDA

October 4, 2001

The Town Center Hotel, Maryland Ballroom, 8727 Colesville Road

Silver Spring, Maryland

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.

 

8:30 Call to Order

Introduction of Committee

Conflict of Interest Statement

8:40 Sponsor Presentation

10:10 FDA Presentation

11:40 Questions

12:00 Lunch

1:00 Open Public Hearing

2:00 Questions to the Committee

2:10 Committee Discussion

5:00 Adjourn