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 CBERs 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