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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Amendment Letter - Berinert, July 8, 2008

July 8, 2008

Our STN:  BL 125287/0

CSL Behring LLC
Attention:  Paul Hartmann, R.Ph.
1020 First Avenue
P.O. Box 61501
King of Prussia, PA 19406-0901

Dear Mr. Hartmann:

We received your 19 June 2008 amendment to your biologics license application (BLA), submitted under section 351 of the Public Health Service Act, for C1 Esterase Inhibitor (Human) on 20 June 2008.

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 06 December 2008.

If you have any questions, please contact the Regulatory Project Manager, Nannette Cagungun, at (301) 827-6174.

Sincerely yours,


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