To: Paul Hartmann
CSL Behring AG
Date: May 21, 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.
- In your study, ZLB04_009CR, there were 8 subjects who withdrew informed consent during the wash-in/wash-out period, and an additional 6 subjects during the “efficacy” period. Please provide the narratives of these subjects, and include within it the (a) the reasons for consent withdrawal, and (b) subsequent therapy (?back to IGIV).
- During the “efficacy” period of study ZLB04_009CR, there were also one patient with multiple violations leading to dropout, and another dropping out due to non-compliance. Please provide narratives detailing (a) what the incidents were that led to withdrawal, and (b) subsequent therapy (?back to IGIV).
Please submit a response to this request as an amendment to the file by June 5, 2009.