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

Product:
Immune Globulin Subcutaneous (Human), 20% Liquid

Applicant:
CSL Behring AG

Telecon Date/Time:30-JUN-2009 12:00 AM Initiated by FDA? Yes
Telephone Number:610-878-4364

Communication Categorie(s):
PNR Acceptance

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

Related STNs:None

Related PMCs:None

Telecon Body:
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.