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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Class 2 Response - Adenovirus

Our STN:  BL 125296/0

Teva Women’s Health, Inc.
Attention:  Valerie Mulligan                                          
425 Privet Road
PO Box 1005
Horsham, PA  19044

Dear Mr. Mulligan:

We have received your September 13, 2010, resubmission to your biologics license application for Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, for the immunization against acute respiratory disease caused by ADV 4 and 7 on September 14, 2010.

We consider this a complete, Class 2 response to our action letter.  Therefore, the user fee goal date is March 16, 2011.

If you have any questions, please contact the Regulatory Project Manager,
Ms. Helen Gemignani, at (301) 827-3070.

Sincerely yours,


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