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Department of Health and Human Services

Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Our STN:  BL 125402/0

Baxter Healthcare Corporation
Attention:  Ms. Aiko Maruya
One Baxter Way
Westlake Village, CA  91362

Dear Ms. Maruya:

This letter is in regard to your biologics license application (BLA) submitted 
under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated June 30, 2011 for 
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase to 
determine its acceptability for filing.  Under 21 CFR 601.2(a) we have filed 
your application today.  The review goal date is April 29, 2012.  This 
acknowledgment of filing does not mean that we have issued a license nor does it 
represent any evaluation of the adequacy of the data submitted.  

At this time, we have not identified any potential review issues.  Our filing 
review is only a preliminary review, and deficiencies may be identified during 
substantive review of your application.  Following a review of the application, 
we shall advise you in writing of any action we have taken and request 
additional information if needed.

If you have any questions, please contact the Regulatory Project Manager, Mark 
Shields, at (301) 827-6173.

Sincerely yours,

Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
Management Branch
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
 

    