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Proposed Proprietary Name Evaluation, February 16, 2012 - Bivigam
Date: February 6, 2012
From: Alpita Popat, PharmD, MBA, Consumer Safety Officer
Through: Lisa L. Stockbridge, Ph.D., Branch Chief
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]
Recommendation: Bivigam proprietary name found Acceptable
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.
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.
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.