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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

June 5, 2009 Approval Letter - PNEUMOVAX®23

Submission Tracking Number (STN): BLA 101094/5313

June 5, 2009 

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 revisions to the package insert.  These revisions include the addition of language to update the package insert to reference current ACIP recommendations.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h.  Please provide content of labeling in Structured Product Labeling format.

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

Sincerely yours,

--signature--

 

Wellington Sun, M.D.
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