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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proposed Proprietary Name Evaluation, August 11, 2011 - Bivigam


Date:                           August 18, 2011
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
                                      Charles Maplethorpe, MD, Medical Officer, OBRR/DH/CRB
Subject:                      Re-evaluation of proposed proprietary name Bivigam (IVIG Gammaglobulin)
                                             BLA 125389
Recommendation:      Bivigam proprietary name found Acceptable
Executive Summary:
APLB performed a re-evaluation of the proposed proprietary name Bivigam, an IVIG Gammaglobulin, to determine if any new products were approved since our previous review on February 14, 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. 
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 September 3, 2011. There are no newly marked products whose names resembled Bivigam.
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.