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Vaccines, Blood & Biologics
Date: August 18, 2011
From: Alpita Popat, PharmD, MBA, Consumer Safety Officer
Through: Lisa L. Stockbridge, Ph.D., Branch Chief
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)
Recommendation: Bivigam proprietary name found Acceptable
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.