Vaccines, Blood & Biologics
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December 30, 2009 Approval Letter - Rotarix
Our STN: BL 125265/187
Attention: Benedicte T. Dupasquier, PharmD
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Dr. Dupasquier:
We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, to revise the package insert and patient package insert to now include a contraindication for demonstrated history of hypersensitivity to the vaccine or any components of the vaccine, in the Warning and Precautions section that postmarketing cases of intussusception have been reported in the U.S. in temporal association with Rotarix administration, and in the Post-marketing Experience section reports of intussusception (including death) and Kawasaki Disease.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccine
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling