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Vaccines, Blood & Biologics

Re-evaluation of Proposed Proprietary Name PROVENGE - Provenge, March 9, 2010

MEMORANDUM Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

DateMarch 9, 2010
FromCatherine Miller, Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Division of Case Management (DCM)
ThroughEle Ibarra-Pratt, RN, MPH, Branch Chief, APLB
ToThomas Finn, PhD, Chairperson, OCTGT/DCGT/CTB
Bindu George, MD, OCTGT/DCEPT
SubjectRe-evaluation of proposed proprietary name PROVENGE®
BLA STN 125197
Recommendation:Proposed proprietary name PROVENGE® is Acceptable

Executive Summary and Recommendation:
APLB has performed a re-evaluation of the proposed proprietary name, PROVENGE, to determine if any new products have been approved since our previous review on April 18, 2007 (see the EDR for the review memo) that would change our previous recommendation.  APLB found that no new products have been approved that would change our previous recommendation.  Therefore, we recommend that the proposed proprietary name PROVENGE be found Acceptable.

Proposed Proprietary Name Evaluation:
APLB re-reviewed the proprietary name because substantial time had passed since our last review and to ensure that our review was within 90 days of approval.  APLB has identified a proposed proprietary name, PRIVIGEN (BLA STN 125201), that has strong orthographic and phonetic similarities and, therefore, the potential for confusion with PROVENGE.  However, because of differences in containers, storage conditions, preparations, frequency of infusion, labeling, patient identification information, and indications, APLB believes that the potential for confusion is low. 

DailyMed at
RMS-BLA report: Product by Proprietary Name

If you have any questions, please contact Catherine Miller at 301-827-3028.

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