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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

January 21, 2011 Approval Letter -Pneumococcal, Polyvalent

Our STN: BL 101094/5455


Merck Sharp & Dohme Corp.
Attention: Alison Fisher
P. O. Box 4
770 Sumneytown Pike
West Point, PA 19486

Dear Dr. Fisher:

We have approved your request to supplement your biologics license application for
Pneumococcal Vaccine, Polyvalent, with changes to the package insert to update the Geriatric
Use and the Adverse Reactions sections.

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/U
CM072392.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,
 

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research