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.