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Vaccines

Record of Telephone Conversation, March 1, 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: 01-Mar-2011 01:11 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request

Author: HELEN GEMIGNANI
Telecon Summary:
Information Request - Viral Harvest Spec
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@tevausa.com]
Sent: Tuesday, March 01, 2011 1:11 PM
To: Gemignani, Helen S
Cc: John Ianacone
Subject: RE: Information Request - Viral Harvest Spec
Helen,

I believe the following information addresses the question. 

Agency Question: 
Can you specify the specification for the Viral Harvest Test for ---------------(b)(4)------------------------------------------------------(pg 6 on the draft LRP)?

TWH Response:
 In Amendment #34, response to Question 9.1 (pg 7 of 9) we indicated that the ----(b)(4)--- specification for pre-filtration Bulk Virus (Viral Harvest) as well as final Formulated Virus would be            --------(b)(4)-------  In addition, our response under the section, Assay Changes and Updates, 1.               --(b)(4)-- (pg 8 of 9), we indicated that the -------(b)(4)------------ method would replace the --------------(b)(4)----- method and be implemented for all Bulk Virus and Formulated Virus.  These changes in specification ------(b)(4)------------- and acceptance criteria ----------(b)(4)------ will be implemented with any new batches of Adenovirus Type 4 and Type 7 manufactured by                         ---(b)(4)-----.  However, it must be kept in mind that previously manufactured and released batches of Adenovirus Type 4 and Type 7, either currently in inventory in VA or formulated and currently stored at --(b)(4)--, will have been tested and released using the previous method and acceptance criteria of -----(b)(4)-----.  Thus not until newly manufactured batches enter the pipeline will the new specifications be effective.

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