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Vaccines, Blood & Biologics

Review of GSK - Labeling - Rotarix


DATE: November 21, 2008

FROM: Daphne Stewart-Bennett, CSO,
Division of Vaccines and Related Products Applications,

THROUGH: Laraine Henchal, Branch Chief, RMSB/DVRPA

TO: BLA STN 125265/89 File

SUBJECT: Review of GlaxoSmithKline Biologicals, BLS 125265/89
Rotavirus Vaccine, Live, Oral - Labeling


GlaxoSmithKline Biologicals has submitted a Biologic License Supplement for Rotavirus Vaccine, Live, Oral Labeling. P er voicemail from Laraine Henchal (CBER) to Donna Boyce (GSK) on July 25, 2008 (see telecon in BIRAMS under IND -(b)(4)- of that date), these changes are submitted in this CBE supplement. The purpose of this supplement is to correct an error in the instructions for the storage conditions before and after reconstitution of the vial of lyophilized vaccine on all labels for this product. The revision of the inner and outer cartons and container labels pertaining to the wording of “Do not freeze; discard if frozen” applies to the diluent labels and refrigerate vaccine at 2 o to 8 o C (36 o to 46 oF) applies to the vial labels and both of these changes apply to the reconstituted vaccine.

Labeling Review

Package Insert: I have reviewed the label and it appears to be in compliance with 21 CFR 201.57.

Cartons: I have reviewed the labels and it appears to be in compliance with 21 CFR 610.61.

Containers: I have reviewed the labels and it appears to be in compliance with 21 CFR 610.60.


Therefore, I have determined that these label changes for the package insert, cartons, and containers are acceptable.

Daphne Stewart-Bennett, CSO

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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