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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Review Approval Letter - Bivigam

 

Our STN: 125389/0                                                                          
 
Biotest Pharmaceuticals Corporation
Attention: Matthew Vaughn
5800 Park of Commerce Blvd. NW
Boca Raton, FL  33487
                         
Dear Mr. Vaughn:
 
We have reviewed your submission to your biologics license application (BLA) for Immune Globulin Intravenous (Human), dated January 14, 2011, requesting a proprietary name review. 
 
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, Bivigam, is acceptable at this time.
 
If you have any questions, please contact Pratibha Rana at (301) 827-6124.
 
Sincerely yours,
 
 /s/
 
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research