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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, March 17, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Sunday, March 17, 2013 11:08 AM
To:                                  'Kevin Smyth (kevin_smyth@baxter.com)'
Cc:                                  Omokaro, Stephanie; Jain, Nisha; Ovanesov, Mikhail V.
Subject:                          Information Request for BL 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smyth:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We are providing the following comments and request for additional information to continue our review:
 
1.     After review of your amendment dated March 1, 2013, regarding your response to antibodies to rFurin and binding FIX antibodies, FDA requests the following:
 
a.      Please submit case report forms for the following subjects:
 
1)     –b(6)-----------
2)     –b(6)-----------
3)     –b(6)-----------
4)     –b(6)-----------
5)     –b(6)-----------
6)     –b(6)-----------
 
b.     Please submit a table similar to your responses to Q3a, Q3b and Q3c (number of bleeding episodes before and after detection of antibodies) for subjects that had both positive rFurin and FIX binding antibodies.
 
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 March 28, 2013 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 tentatively June 30, 2013.
 
Please send an acknowledgement message for receipt of this request.
 
If you have any questions, please contact me at (301) 827-9167.
 
Sincerely,
 
 
Edward Thompson
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
 
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