Food and Drug Administration

Oncologic Drugs Advisory Committee

December 6, 2001

Briefing Information

Morning Session

NDA 20-571, Camptosar® Injection (irinotecan hydrochloride injection), Pharmacia & Upjohn Company, combined with 5FU/leucovorin ("Saltz" regimen), approved for the first-line treatment of patients with metastatic colorectal cancer: Post-marketing safety issues

Sponsor Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Pharmacia & Upjohn Company   [pdf version]

Pharmacia & Upjohn Company, errata page  [pdf version]

Food and Drug Administration Information

Executive Summary  [pdf version] [htm version] [Word version]

Camptosar + 5-FU/LV for First-Line Treatment of Metastatic Colorectal Cancer: Post-Marketing Reevaluation of Safety, November 2001, Isagani M Chico, MD  [pdf version] [htm version] [Word version]