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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 12, 2009 Approval Letter - Rotarix

February 12, 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:

W We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, to include changes to your package insert and container/carton labels to move the phrase "Do not freeze; discard if frozen" from its location next to the description for vaccine vials to the proper location next to the description for the diluent and for reconstituted vaccine.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide this labeling as a PDF-format electronic copy.

We will include the information contained in the above-reference 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