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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. Angela Blackshere
One Baxter Way
Westlake Village, CA 91362

Dear Ms. Blackshere:

We received your April 25, 2014 amendment to your biologics license application 
(BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 
262) for Immune Globulin Infusion (Human), 10% with Recombinant Human 
Hyaluronidase, on April 28, 2014.

We consider your submission a major amendment under the reauthorization of the 
prescription drug user fee program in the Food and Drug Administration 
Amendments Act of 2007.

Because we received this major amendment within three months of the action due 
date, we will add an additional three months to the time by which we should 
complete our review.  Therefore, the action due date is September 12, 2014.

If you have any questions, please contact the Regulatory Project Manager, Cherie 
Ward-Peralta, MS, at (301) 827-9170.

Sincerely yours,

Basil Golding, MD
Director
Division of Hematology 
Office of Blood Research and Review    
Center for Biologics 
Evaluation and Research
 

    
 