June 12, 2008 Approval Letter - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
June 12, 2008
Our STN: BL 125126/758
Merck & Co., Inc.
Attn: Patrick Brill-Edwards, M.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Brill-Edwards:
We have approved your supplement to your biologics license application (BLA) for Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (GARDASIL®), to include arthralgia, myalgia, asthenia, fatigue, and malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, to include corresponding changes to the patient package insert, and to include additional minor editorial changes to the package insert.
Please submit all final printed labeling at the time of use and include 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 BLA file.
/Loris McVittie, Ph.D./
Loris McVittie, Ph.D.
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Package Insert Labeling