
 
 Resubmission Letter, December 19, 2013 - Hyqvia

 
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 have received your December 11, 2013 resubmission to your biologics license 
application for Immune Globulin Infusion (Human), 10% with Recombinant Human 
Hyaluronidase on December 12, 2013.

The resubmission contains Pharmacology/Toxicology Study Protocols and Final 
Reports, Revised Labeling, and a Phamacovigilance Plan that you submitted in 
response to our July 27, 2012 complete response letter. 

We consider this a complete, class 2 response to our action letter.  Therefore, 
the user fee goal date is June 13, 2014.

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

Sincerely yours,

Iliana Valencia
Branch Chief, Regulatory Project
Management Branch
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
 

    
 


