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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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
UG2D-68
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.

Sincerely yours,

/Loris McVittie, Ph.D./
Loris McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Package Insert Labeling

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