|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.
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.