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From: Shields, Mark
Sent: Friday, October 14, 2011 11:19 AM
To: 'Aiko_Maruya@baxter.com'
Subject: 125402/0 proprietary name review.

Hello Ms. Maruya,

We have reviewed your submission dated July 28, 2011 to your biologics license 
application (BLA) for Immune Globulin Infusion (Human), 10% with Recombinant 
Human Hyaluronidase, requesting a proprietary name review. 

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) 
we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable 
regulations, your proposed proprietary name, HyQvia, is acceptable at this time. 
We will perform another proprietary name review of HyQvia closer to the time of 
the action due date to ensure we have not approved a product with a conflicting 
proprietary name in the interim.

Best Regards,

Mark A. Shields, RAC 
Regulatory Project Manager 
HFM-380  FDA/CBER 
Office of Blood Research and Review 
Division of Blood Applications 
301-827-6173 fax 301-827-2405 
email: mark.shields@fda.hhs.gov 
1401 Rockville Pike 
Rockville, MD 20852-1448

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