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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 1, 2010 Approval Letter - Rotarix

Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

Our STN: BL 125265/287

GlaxoSmithKline Biologicals Attention: Benedicte T. Dupasquier
2301 Renaissance Boulevard
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 Human Rotavirus Vaccine, Live, Oral (Rotarix®), to update the package insert and patient information labeling to reflect the presence of Porcine Circovirus Type-1 in the vaccine.

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

Attachment: Approved Final Draft Labeling