Record of Telephone Conversation, August 16, 2010 - Adenovirus

Submission Type: BLA Submission ID: 125296/0 Office: OVRR

Product:
Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant:
Teva Women's Health, Inc.

Telecon Date/Time: 16-Aug-2010 11:36 AM Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Other - UNII Codes

Author: LAWRENCE CALLAHAN

Telecon Summary:
UNII Code Request

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No


Related STNs: None

Related PMCs: None

Telecon Body:


From: Callahan, Lawrence 
Sent: Monday, August 16, 2010 11:36 AM
To: Gemignani, Helen S; Switzer, Frank; Peden, Keith
Cc: Hithe, Darlene; CBER SRS; Levis, Robin
Subject: RE: UNII Code Request - STN 125296/0 - Adenovirus Vaccine


We have created the following UNII for the adenovirus antigens

HUMAN ADENOVIRUS SEROTYPE 4 STRAIN CL-68578 UNII FKD3DUK39I

HUMAN ADENOVIRUS SEROTYPE 7 STRAIN 55142 UNII TM54L796SN

Larry Callahan, Ph. D. 
Food and Drug Administration 
Building 32, 4154 
Phone 301-796-8489 
email: lawrence.callahan@fda.hhs.gov 
Mailing Address 
Building 32, room 4103 
10903 New Hampshire Ave. 
Silver Spring, MD 20993
