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
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