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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Notification Letter - Hizentra, June 30, 2009

Our STN:  BL 125350/0

CSL Behring AG
Attention:  Mr. Paul R. Hartmann
CSL Behring1020 First Ave.
P.O. Box 61501
King of Prussia, PA  19406-0901

Dear Mr. Hartmann:

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated April 30, 2009, for Immune Globulin Subcutaneous (Human), 20% Liquid, to determine its acceptability for filing.  Under 21 CFR 601.2(a), we have filed your application today.  The review goal date is February 28, 2010.  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 no later than January 29, 2010.  If postmarketing study commitments (506B) are required, we will contact you no later than January 29, 2010.

At this time, we have not identified any potential review issues.  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, please contact the Regulatory Project Manager, Pratibha Rana, at (301) 827-6124.

Sincerely yours,

 

for Sheryl A. Kochman
Acting Division Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research