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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Major Amendment - Wilate, August 2, 2007

Our STN: BL 125251/0

Octapharma Pharmazeutika Produktionsges. m.b.H
Attention: Barbara Rangetiner, Ph.D.
Oberlaaer Strasse 235
A-1100 Vienna
Austria

Dear Dr. Rangetiner:

We received your 23-JUL-2007 amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for Von Willebrand Factor Concentrate (Human) on 25-JUL-2007.

We consider your submission a major amendment under the Prescription Drug User Fee Act of 1992.

Because we received this major amendment within three months of the action due date on this application we will add an additional three months to the time by which we should complete our review. Therefore, the goal date is 13-JAN-2008.

If you have any questions, please contact Mr. Franklin T. Stephenson, at (301) 827-6165.

Sincerely yours,

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research