


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.
Director
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
 

   