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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memorandum of Concurrence on Proprietary Name BLA STN125350/0, CSL-Behring’s HizentraTM (Immune Globulin Subcutaneous (Human)) - Hizentra, June 15, 2009

Memorandum of Concurrence on Proprietary Name
BLA STN125350/0, CSL-Behring’s
HizentraTM (Immune Globulin Subcutaneous (Human))

DATE: June 15, 2009
FROM:Hon-Sum Ko, Medical Officer, CBER/DH/CRB, HFM-392
THROUGH:Nisha Jain, Acting Chief, CBER/DH/CRB, HFM-392
TO:The File for BLA STN 125350
SUBJECT:Proprietary Name for Immune Globulin Subcutaneous (HizentraTM) of
CSL-Behring

CSL-Behring has submitted BLA STN 125350 under the proprietary name HizentraTM.

Lisa Stockbridge of APLB has reviewed this proprietary name and found it acceptable. Her review is attached to this memo.

I have read Lisa Stockbridge’s review and agree with her that this name is not regarded as false, misleading or fanciful. Although there are drug names that have some similarity to Hizentra, including Herceptin, Hazaar, Hytrin, Hydrea,Isentress, and Selzentry, the potential for confusion is not considered to be high.

Lisa Stockbridge recommends the following to sent to CSL-Behring:

We have considered your proposed proprietary name, Hizentra, in consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) and conclude that under 21 CFR Part 201 the proposed proprietary name is tentatively acceptable at this time.  

Since a significant amount of time may pass between now and licensure of your product, a re-evaluation of the proprietary name, Hizentra, will be performed closer to the time of approval to ensure that FDA has not approved a product with a conflicting proprietary name in the interim.

Recommendation
I concur that the proprietary name “Hizentra” is acceptable at this time, and recommend including the text below in the letter to be sent to the Applicant:

We have considered your proposed proprietary name, Hizentra, in consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) and conclude that under 21 CFR Part 201 the proposed proprietary name is tentatively acceptable at this time.  

Since a significant amount of time may pass between now and licensure of your product, a re-evaluation of the proprietary name, Hizentra, will be performed closer to the time of approval to ensure that FDA has not approved a product with a conflicting proprietary name in the interim.