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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Filing Letter - Adenovirus

Our STN: BL 125296/0

Duramed Research, Inc.
Attention: Joseph A. Carrado
One Belmont Avenue, 11th Floor
Bala Cynwyd, PA 19004

Dear Mr. Carrado:

This letter is in regard to your biologics license application (BLA) for Adenovirus Type 4 and Type 7 Vaccines Live Oral, for the active immunization against acute respiratory disease caused by ADV 4 and 7, submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated September 30, 2008, for your Adenovirus Type 4 and Type 7 Vaccines Live Oral, to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is July 31, 2009. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.

We will contact you regarding your proposed labeling and if post marketing study commitments (506B) are required, no later than June 30, 2009.

At this time, we have not identified any potential review issues for inclusion in this letter. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.

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

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