Vaccines, Blood & Biologics

October 19, 2007 Approval Letter - Humate-P

Our STN: BL 103960/5346

CSL Behring GmbH
Attention: Paul Hartmann, R.Ph.
1020 First Avenue
King of Prussia, PA 19406-0901

Dear Mr. Hartmann:

We have approved your request to supplement your biologics license application for Antihemophilic Factor/von Willebrand Factor Complex (Human), to include a change in the storage conditions (up to 25°C) for the complete shelf life of 24 months and a corresponding revision in the labeling.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

--- signature ---

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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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