Vaccines, Blood & Biologics

November 27, 2013 Approval Letter - Rotarix

Our STN:BL 125265/441

GlaxoSmithKline Biologicals
Attn: Ms. Elisa Harkins
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Harkins:

We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Rotarix®, to change the product labeling in accordance with the guidance issued on March 11, 2013, entitled Draft Guidance for Industry and Food and Drug Administration Staff-Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.

Please provide your final content of labeling in Structured Product Labeling (SPL).In addition, please submit three original paper copies for carton and container final printed labeling. All final labelingshould be submitted as Product Correspondence to this BLAat 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 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

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 includes these changes.

We will include the 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

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