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Vaccines, Blood & Biologics

Acknowledgement Letter - December 5, 2008 - Gammaplex

December 5, 2008

Bio Product Laboratory
Attention:  Dr. Andrew West-Watson 
Daggar Lane
Elstree, Hertfordshire  WD6 3BX
United Kingdom

Dear Dr. West-Watson:

We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:


Our Submission Tracking Number (STN):  BL 125329/0


Name of Biological Product:  Immune Globulin Intravenous (Human), 5% Liquid   


Indication:  Treatment of patients with primary immunodeficiency disease


Date of Application:  November 14, 2008


Date of Receipt:  November 17, 2008


Action Due Date:  September 17, 2009


US License Number and Manufacturing Site:  Pending

All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred.  We note that you have not fulfilled the requirements.  We acknowledge receipt of your request for a waiver of pediatric studies for this application.  Once the application has been filed we will notify you whether we have waived the pediatric study requirement for this application.

We request that you submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number.  Send all correspondence to the following address:

Jay Epstein. M.D.
Office of Blood Research and Review
DCC, Suite 200N, HFM-99
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.

If you have any questions, please contact me at (301) 827-9427.

Sincerely yours,


Kelly Lewis
Regulatory Project Manager
Division of Blood Application
Office of Blood Research and Review
Center for Biologics  Evaluation and Research

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