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Vaccines, Blood & Biologics

3/31/2008 Telecon - Rotarix


DATE: March 31, 2008

FROM: Laraine S. Henchal, Microbiologist Reviewer, DVRPA, CBER, Review Committee Chair, STN 125265/0

SUBJECT: Telecon with GSK to discuss wording of indication for Rotarix in labeling

The participants discussed a number of options for the labeled indication for Rotarix, and whether language should be specific with types listed or kept general. No decision was made. A discussion with a larger group including CBER management will be required.

CBER participants:

Steve Rosenthal
Paul Kitsutani
Laraine Henchal

GSK particpants:

Donna Boyce
Barbara Howe
Claire Kahn
Leonard Friedland
Benedicte Dupasquier
Tracey Lee

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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