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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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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,

--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

 

Contact FDA

(800) 835-4709
(301) 827-1800
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Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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