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Vaccines, Blood & Biologics

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Proprietary Name Withdrawal, March 16, 2009 - 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:

We acknowledge receipt of your February 19, 2009, submission to your biologics license application (BLA) for Adenovirus Type 4 and Type 7 Vaccines, Live, Oral requesting that the proposed proprietary name, ----(b)(4)---, be withdrawn.  The withdrawal procedure is now considered complete. 

If you have any questions, please contact Darlene Hithe at (301) 827-3070.

Sincerely yours,

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