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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Review Acceptance Memorandum - Anascorp

 

Our STN: 125335/0 
 
Instituto Bioclon, S.A. de C.V.
Attention: -----(b)(4)------------
------(b)(4)-----------
-------(b)(4)---------------
-------(b)(4)------------
                         
Dear -----(b)(4)----:
 
We have reviewed your submission dated February 12, 2009 to your biologics license application (BLA) for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine) requesting a proprietary name review.
 
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB), we have considered your proposed proprietary name Anascorp and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable with concerns at this time. There is a potential risk for medication error with Aranesp; however, these risks may be minimized by providing packaging that will differentiate Anascorp from Aranesp.
 
If you have any questions, please contact Debbie Cordaro at (301) 827-6157.
 
Sincerely yours,

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