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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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May 1, 2009 Approval Letter - Rotarix

May 1, 2009

Our STN: BL 125265/126
GlaxoSmithKline Biologicals
Attention: Benedicte T. Dupasquier
2301 Renaissance Blvd.
P.O. Box 61540
King of Prussia , PA 19406-2772

Dear Ms. Dupasquier:

We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Rotarix®, to update the Prescribing Information.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

We will include information contained in the above-referenced supplement in your biologics 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


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