Antiviral Drug Products Advisory Committee Meeting

10/17/01


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Table of Contents

Antiviral Drug Products Advisory Committee Meeting

Division of Special Pathogen and Immunologic Drug Products Voriconazole Review Team

Indications Requested in the NDA

FDA Presentation

Treatment of Invasive Aspergillosis

Treatment of Invasive Aspergillosis

Study 307/602

Study 307/602 Primary Efficacy Endpoint

Study 307/602 Additional Efficacy Analyses

Study 307/602 Survival

Study 304

Study 304

Historical Control (HC) Study 1003

Study 304/ Historical Control Study 1003

Historical Control Issues

Historical Control Issues (cont.)

Aspergillosis Summary

Clinical Safety

Clinical Safety

Clinical Safety

Ocular Safety

Ocular safety

Ocular Safety

Clinical Safety

Cardiac Safety

Cardiac Safety

Clinical Safety

Hepatic Safety Summary

Clinical Safety

Rash

Rash

Clinical Safety

Drug Interactions with Voriconazole In Vitro Metabolism

Drug Interactions with Voriconazole In Vivo Metabolism

Clinical Safety

Clinical Safety

Clinical Safety

Ocular Safety

Ocular safety

Ocular Safety

Clinical Safety

Cardiac Safety

Cardiac Safety

Clinical Safety

Hepatic Safety Summary

Clinical Safety

Rash

Rash

Clinical Safety

Drug Interactions with Voriconazole In Vitro Metabolism

Drug Interactions with Voriconazole In Vivo Metabolism

Author: CDER USER