BLA Filing Meeting Memo - Rotarix

MEMORANDUM

DATE:	July 10, 2007
FROM:	Laraine S. Henchal, Microbiologist Reviewer, DVRPA, CBER, Review Committee Chair, STN 125265/0
SUBJECT:	BLA Filing Meeting Memo for STN#125265/0, Rotarix®

The committee met on July 10, 2007 to discuss whether to file BLA/STN #125265/0 for Rotarix® Rotavirus Vaccine Live Oral from GlaxoSmithKline Biologicals.

No refuse-to-file issues were identified, so the BLA will be filed (filing letter due date is 3 August 07).

The "deficiencies identified" letter (due date 17 August) was discussed and the following deficiencies were identified thus far:

1) No raw data has been submitted for statistical analysis.

2) Reproducibility data seems to be missing from potency assay validation statement.

Participants were urged to complete their initial reviews and identify any deficiencies for the letter by August 10. Send to either Luba Vujcic or Laraine Henchal.

The inspection is tentatively planned for early November.

CBER committee members present at meeting:

Laraine Henchal
Jingyee Kou
Steve Rosenthal
Paul Kitsutani
Gale Heavner
Phil Snoy
M. David Green
Anthony Hawkins
Dino Feigelstock
Pete Amin
Jonathan McGinnis
Hector Izurieta
Lev Sirota
Karen Meysick
Sandra Menzies
Christian Lynch
Nancy Chamberlin
Steve Feinstone