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
We have the following Information Request in regard to Product Dating:
- Please submit real time stability data for each adenovirus type to support the requested 24 month shelf life.
- Please specify what date you intend to use as the “Date of Manufacture” for the dating period for the final product.