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Record of Telephone Conversation - Hizentra, June 30, 2009
System Info - 98068 RANA, PRATIBHA 30-Jun-2009 16:32:36 RANAP
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125350/0 Office:OBRR
Immune Globulin Subcutaneous (Human), 20% Liquid
CSL Behring AG
Telecon Date/Time:30-JUN-2009 12:00 AM Initiated by FDA? Yes
Author: PRATIBHA RANA
Telecon Summary: Notification of Trade Name acceptable at this time.
FDA Participants: Pratibha Rana
Non-FDA Participants: Paula Hines
Trans-BLA Group: No
I called the Paula Hines and notified that the trade name is acceptable at this time but will be reviewed again closer to the Action Date.