September 7, 2010 Approval Letter - RotaTeq

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

Our STN: BL 125122/731

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 include changes to the package insert regarding transmission of vaccine virus strains to non-vaccinated contacts.

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

Sincerely yours,

/signature/

Wellington Sun, M.D.
Director
Division of Vaccines andRelated Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling