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CSL Behring AG Letter - Hizentra, January 15, 2009
To: Paul Hartmann
CSL Behring AG
Date: January 15, 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.
- Please submit a translation of the certificate of analysis for L-proline used in study PSR 01/07 that clearly indicates the expiration date.
- In study no. HYR 01/06, titled “Effects of Sandoglobulin, IgPro10 and IgPro20 on blood pressure in rats” in the conclusions section you state that “…lot number 43109-00001 of IgPro20 caused a similar hypotension … to Sandoglobulin. Lot 43109-00002 appeared to cause a slightly more pronounced hypotension.” However, according to table 2 (pg 14) the opposite is true. You continue to say that such an effect “…was in the range of the model’s variance”. Please clarify.
- Please submit the names of the responsible personnel corresponding to the signatures shown in “Legacy Study Report Bacterial Stress Gene Assay Zen-0995” signature page (pg 2).
Please submit a response to this request as an amendment to the file by January 30, 2010. Responses to items 2 and 3 (sent to you in a previous IR) were not located; please cross-reference if already sent.