• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu


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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448