
Information Request Email, September 13, 2011 - Hyqvia




  
Our Reference:  BL 125402/0

Baxter Healthcare Corporation
Attention:  Ms. Aiko Maruya  
September 13, 2011

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 information on all sterilization and aseptic processes as 
  described in the “Guidance for Industry for the Submission of Documentation 
  for Sterilization Process Validation in Application for Human and Veterinary 
  Drug products.”
  Please submit the facility and equipment details for the rHuPH20 component.

This submission cross references DMF (b)(4) and DMF (b)(4) filed by Baxter       
       ------(b)(4)---------------------, which provides the facility and 
equipment details for the rHuPH20 component.  CBER’s policy is to require all 
information relevant to this application be submitted and not cross-referenced.

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 September 27, 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
 

    
 
