Vaccines, Blood & Biologics
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February 12, 2009 Approval Letter - Rotarix
February 12, 2009
Our STN: BL 125265/89
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.
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research