


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





    Date: 
      March 9, 2010

    From: 
      Catherine Miller, Consumer Safety Officer
      Advertising and Promotional Labeling Branch (APLB)
      Division of Case Management (DCM)

    Through: 
      Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB

    To: 
      Thomas Finn, PhD, Chairperson, OCTGT/DCGT/CTB
      Bindu George, MD, OCTGT/DCEPT
      Chaohong Fan, MD, OCTGT/DCEPT/CEB
      Lori Tull, CSO, OCTGT/RMS

    Subject: 
      Re-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. 

References:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda
DailyMed at http://dailymed.nlm.nih.gov/dailymed/about.cfm
RMS-BLA report: Product by Proprietary Name

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