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May 1, 2009 Approval Letter - Rotarix

May 1, 2009

Our STN: BL 125265/89

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,

-- signature --

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

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