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U.S. Department of Health and Human Services

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Record of Telephone Conversation, January 25, 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: 25-Jan-2011 10:41 AM        Initiated by FDA? Yes

Communication Category: Information Request

Author: Helen Gemignani

Telecon Summary: Request for 24 month stability data and for Teva's definition of Date of Manufacture.

FDA Participants: Helen Gemignani

Non-FDA Participants: Valerie Mulligan
Telecon Body:

We have the following Information Request in regard to Product Dating:

  1. Please submit real time stability data for each adenovirus type to support the requested 24 month shelf life.
  2. Please specify what date you intend to use as the “Date of Manufacture” for the dating period for the final product.