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Department of Health and Human Services

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

Our Reference: BL 125402/0

Baxter Healthcare Corporation 
Attention: Ms. Aiko Maruya 
September 27, 2011
Sent by email

Dear Ms. Maruya:

We are reviewing your June 30, 2011 biologics license application (BLA), for 
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase. We 
are providing the following comment and request for additional information to 
continue or review:
  Please provide the arithmetic mean and standard deviation of PK parameters and 
  trough levels of IgG, IgG sub-classes, and levels of antibody to tetanus, 
  Haemophilus, influenza (H. influenza), measles and hepatitis B (where 
  applicable) for IV and SC treatment in studies 160601, 160602, and 160603.

The review of this submission is on-going and issues may be added, expanded 
upon, or modified as we continue to review this submission.

Please submit your response to this information request as an amendment to this 
file by October 3, 2011 referencing the date of this request.

If you anticipate you will not be able to respond by this date, please contact 
the Agency immediately so a new response date can be identified.

If we determine that your response to this information request constitutes a 
major amendment, we will notify you in writing.

The action due date for this file is April 29, 2012.

If you have any questions, please contact me at (301) 827-6173.

Sincerely,
Debbie Cordaro

For

Mark Shields, RAC Team Leader FDA/CBER/OBRR/DBA/RPMB
 

    
 