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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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January 13, 2011 Approval Letter - BCG Vaccine

Our STN:  BL 103050/5072

Organon Teknika Corporation, LLC
Attention: Lawrence Starke, Ph.D.
100 Rodolphe Street
Building 1300
Durham, NC  27712

Dear Dr. Starke:

We have approved your request to supplement your biologics license application for BCG Vaccine to revise the Warnings, Laboratory Tests, Treatment and Schedule subsection of Dosage and Administration and the Pediatric Dose sections of the package insert, and to also include an instruction sheet for the multi-puncture administration device supplied separately for use with the product.

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 information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/signature/

  Jay Slater, M.D.
Acting Director
Division of Bacterial, Parasitic
and Allergenic Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling