Vaccines, Blood & Biologics

September 7, 2010 Approval Letter - RotaTeq

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
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,


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

Attachment: Approved Final Draft Labeling

Page Last Updated: 10/08/2010
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