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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

August 6, 2008 Approval Letter - Pneumovax 23

August 6, 2008

Submission Tracking Number (STN): BLA 101094/5245

Merck & Co., Inc.
Attention: Alison Fisher, Ph.D.
UG2D-68
P.O. Box 1000
North Wales, PA 19454-1099

Dear Dr. Fisher:

We have approved your request to supplement your biologics license application for Pneumococcal Vaccine Polyvalent, PNEUMOVAX®23, to include the new term “Leukocytosis” in the Adverse Reactions section of the package insert.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

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

Sincerely yours,

/Loris D. McVittie/

Loris D. McVittie
Acting 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


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