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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, March 4, 2011 - 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: 04-Mar-2011 12:54 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request

Author: HELEN GEMIGNANI
Telecon Summary:
HSA Content
FDA Participants: None
Non-FDA Participants: VALERIE MULLIGAN
Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:


From: Valerie Mulligan [mailto:Valerie.Mulligan@barrlabs.com]
Sent: Friday, March 04, 2011 12:54 PM
To: Gemignani, Helen S
Cc: John Ianacone; andrew towle
Subject: HSA Content
Dear Helen,

In response to your question regarding HSA content per unit dose of the Adenovirus, Oral, Type 4 and Adenovirus, Live, Oral Type 7 tablets, and for the purpose of possibly listing its concentration in the PI, we have calculated that each tablet contains HSA at a concentration of -----(b)(4)----- (the calculated number comes out to be -----(b)(4)--------.  So for a two tablet vaccine, the final total HSA content would be -----(b)(4)--------. 

Please let me know if you need any additional information.

All the best,

Valerie

Valerie Mulligan
Sr. Director, Regulatory Affairs 
Teva Women's Health Research
A Division of Teva Branded Pharmaceutical Products R&D, Inc.
425 Privet Road
Horsham, PA 19044

Office: 215.293.7228
Cell:  215.385.4154
Fax: 215.293.7453
valerie.mulligan@tevausa.com