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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, June 27, 2012 - Octaplas

 

From:                    Rana, Pratibha
Sent:                      Wednesday, June 27, 2012 4:40 PM
To:                         Ammons, Stanley
Cc:                         Rangetiner, Barbara
Subject:                 STN 125416/0 Information Request ( 6-27-2012)
Our Reference: STN 125416/0
Octapharma USA, Inc.
 
Attention: Stanley Ammons
 
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.     Upon further review and in consideration of the intended use of OctaplasLG® as an alternative to FFP for all its clinical indications, FDA requests that Octapharma revise the final product release specification as indicated in the following table. 

Parameter
Rationale for Revision
Recommended Limit
Conformance Lot Range
Protein S
------------------------------------(b)(4)--------------------
----(b)(4)-------
--------(b)(4)------------------
2-antiplasmin (A2PI)
----------------------------------(b)(4)-----------------------
----(b)(4)----
---------(b)(4)-----------------------
Factor V
---------(b)(4)---------------------------
----(b)(4)----
-------(b)(4)-------
Factor XI
----------(b)(4)------------------------
----(b)(4)---
----(b)(4)------
Fibrinogen
---------(b)(4)------------------------
----(b)(4)-----
-----(b)(4)------
Factor II (Prothrombin)
-----------(b)(4)------------------------------------------------
---(b)(4)---
----------(b)(4)------------------------
Factor X
---------(b)(4)---------------------------------------------------
---(b)(4)---
---------(b)(4)---------------------
Factor VII
---------(b)(4)-------------------------------------------------
---(b)(4)---
--------(b)(4)-------
ADAMTS13
-------(b)(4)------
---(b)(4)--
-------(b)(4)------

 
  
 
2.   Regarding -----------(b)(4)----- report titled, “____(b)(4)---------------------------                          -----(b)(4)---------, Safety, Leachables and Extractables:
  • although the report presented some data on extractables and potential leachables, there was no explanation of the data as they related to potential toxicity if leached into the product
  • line listings in appendix 1 are illegible
 
Please provide a meaningful discussion of the safety of the -------------(b)(4)--- -----(b)(4)------------------
 
Please submit your response to this information request as an amendment to this file by July 18, 2012 referencing the date of this request.
 
The action due date for this file is October 22, 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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