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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, October 18, 2012 - Octaplas

 

From:                    Rana, Pratibha
Sent:                      Thursday, October 18, 2012 3:26 PM
To:                         Rangetiner, Barbara; Ammons, Stanley; Meindl, Simone
Subject:                 RE: STN 125416/0 Information Request 10-18-2012
 
Sorry meant to write 10-18 on the subject line..
_____________________________________________
From:                    Rana, Pratibha 
Sent:                      Thursday, October 18, 2012 3:23 PM
To:                         Rangetiner, Barbara; Ammons, Stanley; 'Meindl, Simone'
Subject:                 STN 125416/0 Information Request 10-17-2012
 
Octapharma Pharmazeutika Produktionsges.m.b.H.
Our Reference: STN 125416/0
 
Attention: Stanley Ammons
Octapharma USA, Inc.
 
Dear Mr. Ammons:
We are reviewing your December 22, 2011 biologics license application (BLA) for Pooled Plasma, Solvent Detergent Treated (Human). We are providing the following comments and request for additional information to continue our review:
 
1.     Please agree to the following reworded PMC:
 
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
2.   Please submit the English translation of the German Master Batch Record for OPG that was submitted in STN 125416/0.27 (09 October 2012).
 
3.   Please submit word version of most recent revision of the draft labeling text.
 
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 22, 2012 referencing the date of this request.
 
The action due date for this file is January 21, 2012.
 
If you have any questions, please contact me.
 
Sincerely,
Pratibha Rana
Pratibha Rana, M.S.
Regulatory Project Manager
 
FDA/CBER/OBRR
Division of Blood Applications
1401 Rockville Pike
Rockville, MD 20852
Office: (301) 827-6124
Fax: (301) 827-2857
email: pratibha.rana@fda.hhs.gov
 
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