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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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STN 125350/0 Information Request - Hizentra, August 12, 2009

To: Paul Hartmann
CSL Behring AG
Date: August 12, 2009

This is regarding your BLA submission STN 125350/0 for Immune Globulin Subcutaneous (Human), 20% Liquid, submitted to the Agency on April 30, 2009.  FDA continues with the review of the referenced submission and requests CSL Behring AG to provide the following information.

  1. To facilitate reviewing the submission, please submit electronic files in Microsoft Word for Sections 1 to 13 of each clinical study report (ZLB04_009CR, ZLB04_008CR, and ZLB06_003CR) in Microsoft Word.
  2. Please provide an additional xpt file for adverse events showing (a) start time of immediate preceding infusion, (b) end time of immediate preceding infusion, (c) whether the event started between start time and within 48 hours of end of the infusion, and (d) whether event started between start time and within 72 hours of end of the infusion.
  3. Please provide your rationale why 10 pediatric subjects’ data are sufficient to support use of IgPro20 in children and adolescents. Since you will have additional data from European studies that include children and adolescents, please request a Deferral for submission. Please submit a Pediatric Plan document when you request for a PREA deferral for pediatric data submission.

Please submit a response to this request as an amendment to the file by August 21, 2009.  
Thank you.
Pratibha Rana