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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 1, 2010 Approval Letter - RotaTeq

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

Our STN: BL 125122/781

Merck & Co., Inc.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099

Dear Dr. Koser:

We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq®), to update the package insert and patient package insert to reflect the presence of Porcine Circovirus Type-1 and -2 DNA in the vaccine.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

Wellington Sun, M.D.
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