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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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January 13, 2011 Approval Letter - Rotarix

Our STN:   BL 125265/190

GlaxoSmithKline Biologicals
Attention:  Elysia L. Tusavitz
2301 Renaissance Boulevard
P.O. Box 61540,
King of Prussia, PA 19406-2772

Dear Ms. Tusavitz:

We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Rotarix®, to revise labeling to address latex hypersensitivity in the Warnings and Precautions section of the package insert; to include a presentation in a prefilled oral applicator of liquid diluent that has a tip cap which may contain natural rubber latex; and to correct the information regarding latex for the other prefilled applicator that has both a tip cap and a rubber plunger which contain dry natural latex rubber and minor editorial updates. Your initial submission claimed the replacement syringe component did not contain latex, but based on CBER’s review of STN 125106/612, we do not concur with the proposed latex claim.

Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.

In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/
StructuredProductLabeling/default.htm
. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf
.

You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).

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 or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that include these changes. 

We will include the 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