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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 23, 2009 Approval Letter - RotaTeq

Department of Health & Human Services
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

Our STN: BL 125122/636

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, to revise the Contraindications section to include infants with Severe Combined Immunodeficiency Disease (SCID) because of post-marketing reports describing severe gastroenteritis and vaccine viral shedding in these patients. The patient package insert has also been updated accordingly.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

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 and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Silver Spring, MD 20993-0002