October 30, 2008 Approval Letter - Varivax
Our Submission Tracking Number (STN): BL 103552/5276
October 30, 2008
Merck & Co., Inc.
Attention: Donna Zacholski
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
Dear Ms. Zacholski:
We have approved your request to supplement your biologics license application for frozen and refrigerated formulations of Varicella Virus Vaccine Live (VARIVAX) to remove the phrase “(Oka/Merck)” from the generic name on the product carton and container labeling and from within the package insert. In addition we approve your revisions to the package insert to clarify the statement regarding anaphylaxis.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide this labeling as a PDF-format electronic copy.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, MD
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