January 16, 2009
Submission Tracking Number (STN): BLA 101094/5281
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 revisions to the package insert. These revisions include the addition of language to the Adverse Reactions section indicating that certain systemic events may be associated with local injection site reactions and modified text under the heading, Pediatric Use, in the Precautions section.
We acknowledge your written commitment of January 14, 2009, to update the package insert to reference current ACIP recommendations and remove text pertaining to older ACIP recommendations. As discussed with Dr. Rosemary Tiernan and Ms. Julienne Vaillancourt of this office on January 14, 2009, you will amend the CBE labeling supplement submitted on December 5, 2008 (STN 101094/5313) with a revised draft label that reflects these changes.
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.
-- signature --
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling