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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proposed Proprietary Name Evaluation, February 16, 2012 - Bivigam

 

Date:                           February 6, 2012
 
From:                         Alpita Popat, PharmD, MBA, Consumer Safety Officer
                                    CBER/OCBQ/DCM/APLB, HFM-602
 
Through:                    Lisa L. Stockbridge, Ph.D., Branch Chief
                                    CBER/OCBQ/DCM/APLB, HFM-602
 
To:                              Pratibha Rana, RPM, OBRR/DBA/RPMB
                                     Michael Kennedy, PhD, Team Lead, OBRR/DH/LPD
 
Subject:                      Re-evaluation of proposed proprietary name Bivigam [Immune Globulin Intravenous (Human), 10% Liquid]
                                                  BLA 125389
 
Recommendation:     Bivigam proprietary name found Acceptable
__________________________________________________________________________
 
Executive Summary:
APLB performed a re-evaluation of the proposed proprietary name Bivigam [Immune Globulin Intravenous (Human), 10% Liquid], to determine if there were any new products approved since our previous reviews on February 14, 2011 and August 18, 2011. APLB found that no new products were approved that would change our previous recommendation. APLB recommends that the proposed proprietary name Bivigam be found Acceptable. 
 
Background:
APLB re-reviewed the proprietary name to ensure that our review is within 90 days of approval. The PDUFA goal date for this product is April 26, 2012. There are no new marketed products whose name resembles Bivigam.
 
Recommendation:
APLB recommends that the proposed proprietary name, Bivigam be foundacceptable. 
 
If you have any questions concerning this review, please contact Alpita Popat, PharmD, MBA, Consumer Safety Officer at 301-827-6329.
 
References:
http://www.uspto.gov/
http://www.thomsonhc.com
http://www.labeldataplus.com/