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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CSL Behring AG Letter - Hizentra, January 19, 2010

To: Paul Hartmann
CSL Behring AG
Date: January 19, 2010

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.    

We acknowledge your explanations to our earlier questions.  During our review, we noted some items that are not clear to us.

  1. Your response dated 1/7/10 has identified 75 infusions (for all sites combined) that had associated dose discrepancies.  However, at site #15, we noted that at least for 42 additional infusions that had incomplete data or lack of data such as the unavailability of the weight of the bottles on the IMP calculation sheet, the verification dose cannot be calculated.  Please explain and clarify whether the verification doses were calculated for all doses or only those that had all the available information during the monitoring visits.  If so, how many more and how were the diary doses reconciled in such scenarios?
  2. Related to item 1 above, for sites that did not maintain the IMP inventory log on a current and ongoing basis, namely, the sites that did not complete and prospectively maintain the IMP accountability form for a period of time in 2007, please explain how the drug disposition, use, and individual doses were reconciled in a timely manner, if applicable.      

Please submit a response to this request as an amendment to the file by January 28, 2010.

Thank you.

Pratibha Rana