
3-31-2008 Telecon - Rotarix


 
 
MEMORANDUM

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
