February 3, 2006 Approval Letter
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-1448
February 3, 2006
Our STN: BL 125062/57
Octapharma USA, Inc.
Attn: Flemming Nielsen
5885 Trinity Parkway Suite 350
Centreville, VA 20120
Dear Mr. Nielsen:
We have approved your request to supplement your biologics license application for Immune Globulin Intravenous, Human 5% S/D [OCTAGAM] to include labeling changes to the "Warnings/Blood Glucose Testing" and "Precautions/Drug/Laboratory Test Interactions" sections of the package insert strengthening the warning of effects of maltose in the product.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
--- signature ---
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research