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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 17, 2010 Approval Letter - Rotarix

Our STN:  BL 125265/300

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 Rotavirus Vaccine, Live, Oral (ROTARIX®), to update the package insert to include changes to the Warnings and Precautions section and Post-marketing Experience section of Adverse Reactions regarding interim post-marketing safety data from a study conducted in Mexico.  The patient package insert was also revised to include this new information. 

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.

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. 

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

Attachment:  Approved Final Draft Labeling