June 9, 2009 Approval Letter - Gardasil
Our STN: BL 125126/1256
Merck & Co
Attention: Patrick Brill-Edwards, M.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Brill-Edwards:
We have approved your request to supplement your biologics license application for Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, GARDASIL® for the following changes to the package insert:
- The addition of “chills” to the Postmarketing Adverse Reactions section,
- The addition of a new System Organ Class “Respiratory, thoracic and mediastinal disorders” and relocation of the adverse experience “pulmonary embolus” into this class,
- The addition of “Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL,” to the Warnings and Precautions section.
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.
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccine Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling