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Dear Manufacturer: Immune Globulin Intravenous (Human) (IGIV); Class Label Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
December 1, 2003
Please refer to the October 16, 2003 letter regarding your Immune Globulin Intravenous (Human) (IGIV) in which FDA required updates to your product labeling.
This letter is notification that FDA is extending the deadline for the submission of the CBE required in that letter by an additional 45 days. The due date to submit this supplement to your Biologics License is January 14, 2004.
Please indicate in the cover letter of the supplement the date by which you expect to implement the changes.
If you have any questions concerning this letter, please contact Michael Wiack of the Division of Blood Applications, at 301-827-3524.
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Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research