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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 7, 2011 - Bivigam

 

To: Matthew Vaughn
Biotest Pharmaceuticals Corporation

This is regarding your BLA submission STN 125389/0 for Immune Globulin Intravenous (Human), submitted to the Agency on November 3, 2010.  FDA continues with the review of the referenced submission and requests BPC to provide the following information.     
 
  1. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
 
  1. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------: 
Ÿ ---------------------------(b)(4)------------------------------
Ÿ ----------(b)(4)--------------
 
  1. -------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------:
Ÿ -------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------;
Ÿ -----------------------(b)(4)---------------------.
 
  1. Please perform an additional drug substance stability study at ---------(b)(4)-------- assessing --(b)(4)-- titer.
 
  1. Please submit any further final-product stability data that has become available.
 
  1. Please assay --(b)(4)-- titers in retained samples of Bivigam lots that were used in the clinical and stability studies. Please submit those results as well as information on the initial --(b)(4)-- titers, the ages of the lots, the storage conditions for these lots, and the storage conditions in which these clinical samples were kept.
 
Please submit a response to this request as an amendment to the file by May 9, 2011.
Thank you.
Pratibha Rana