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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.
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.
/Loris D. McVittie/
Loris D. McVittie
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling