ANTIVIRAL DRUGS ADVISORY COMMITTEE

February 27, 2001

VALGANCICLOVIR  NDA 21-304

Slides

NDA 21-304 Valganciclovir for the Treatment of CMV Retinitis, Introduction, Debra Birnkrant, MD, FDA   ppt

Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients,  William Boyd, MD, FDA   ppt

Sponsor Presentation

Set 1   ppt   htm

Set 2   ppt   htm

Set 3   ppt

FDA Review of NDA 21-304 Valganciclovir for the Treatment of CMV Retinitis in AIDS, Joseph Toerner, MD, FDA   ppt

Pharmacokinetic Information Submitted to Support Valganciclovir Use in Maintenance Therapy for DMV Retinitis, Robert O Kumi, PhD, FDA   ppt