Submission Type: BLA Submission ID: 125296/0 Office: OVRR
Adenovirus Vaccine Live Oral Type 4 and Type 7
Teva Women's Health, Inc.
Telecon Date/Time: 04-Mar-2011 12:54 PM Initiated by FDA? Yes
1. Information Request
Author: HELEN GEMIGNANI
FDA Participants: None
Non-FDA Participants: VALERIE MULLIGAN
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
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
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,
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