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Vaccines, Blood & Biologics

February 22, 2010 Approval Letter - Rotarix

GlaxoSmithKline Biologicals
Attention: Benedicte T. Dupasquier, PharmD
2301 Renaissance Boulevard
P.O. Box 61540

Dear Dr. Dupasquier:

We have received your February 3, 2010, supplement to your biologics license application for Rotavirus Vaccine, Live, Oral, to revise the package insert, to revise the Contraindications section to include infants with Severe Combined Immunodeficiency Disease (SCID) because of post-marketing reports describing severe gastroenteritis and vaccine viral shedding in these patients.  The patient package insert will also be updated accordingly.

This Supplement has been reviewed under STN 125265/256 and is approved effective this date.

All promotional claims must be consistent with and not contrary to approved labeling.  You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.

This information will be included in your License Application File.

Sincerely yours,


Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment:  Approved Final Draft Labeling

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

Page Last Updated: 03/12/2010
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