September 12, 2008 Approval Letter - Gamunex-C
Our STN: BL 125046/409
Talecris Biotherapeutics, Inc.
Attention: Dr. Mary Ann Lamb
8368 US Hwy 70 West
Clayton , NC 27520
Dear Dr. Lamb:
We have approved your request to supplement your biologics license application for Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified (IGIV-C), for treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
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). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.
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.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research