DATE: October 1, 2001

TO: Advisory Committee Members and Guests

FROM: Voriconazole Review Team

THROUGH: Renata Albrecht, M.D.

Acting Director

Division of Special Pathogen and Immunologic Drug Products

SUBJECT: Errata for Background Package for NDA 21-266 and 21-267: Voriconazole Tablets and Voriconazole for injection

Liver tumors:

"In mice, 24-month oral administration of voriconazole at 50mg/kg…" should read

"In mice, 24-month oral administration of voriconazole at 100mg/kg…"

"In rats, there was an increase in hepatocellular adenomas in high dose females." should read "In rats, there was an increase in hepatocellular adenomas in females treated at 50mg/kg."

Teratogenicity:

"At doses as low as 1mg/kg (equivalent to a human dose of 0.2 mg/kg… should read

"At doses as low as 10mg/kg (equivalent to a human dose of 2 mg/kg.."

Table 1: Under study 150-228 for rifabutin Cmax at 350 mg bid, the upper 90% CI given as 5% should be changed to 105%.

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