Date: January 5, 2009
From: Jean Makie, Regulatory Review Officer
Advertising and Promotional Labeling Branch (APLB), HFM-602,
Division of Case Management (DCM)
Through: Ele Ibarra-Pratt, RN , MPH, Branch Chief, APLB, HFM-602
To: Lewis Markoff, M.D., Medical Officer, OVRR/DVP/LVBD (HFM-451)
Richard Daemer, RPM, OVRR/DVRPA/VVB (HFM-478)
Daryll Miller, RPM, OVRR/DVRPA/VVB (HFM-478)
Office of Vaccine Research and Review (OVRR)
Subject: Re-evaluation of proposed proprietary name IXIARO® [Japanese Encephalitis Virus, Purified, Inactivated Vaccine: IC51 (JE-PIV)] STN 125280/0
Sponsor: Intercell USA, Inc.
Executive Summary :
This BLA is currently under a second-cycle review clock (the applicant’s October 1, 2008 resubmission was classified as a complete, class 2 response). The applicant submitted a request for reevaluation of the proposed proprietary name, Ixiaro, as an amendment to the BLA on November 17, 2008. Although the user fee goal date is April 3, 2009, the product office anticipates taking an action no later than mid-February, 2009.
APLB has performed a re-evaluation of the proposed proprietary name Ixiaro , to determine if any new products have been approved since our previous review completed on September 4, 2008, and to ensure that our current review is within 90 days of approval. APLB found that no new products have been approved that would change our previous recommendation. APLB recommends that the proposed proprietary name Ixiaro be found Acceptable.
APLB recommends that the proposed proprietary name Ixiaro be found acceptable at this time. No recently approved products whose names resemble Ixiaro were found.
- http://www.fda.gov/cder/ob (Electronic Orange Book), current through November, 2008, searched January 2, 2009
- http://www.accessdata.fda.gov/scripts/cder/drugsatfda (CDER New and Generic Drug Approvals through December 31, 2008), searched January 2, 2009
- CBER New BLA, NDA and ANDA approvals lists, updated December 31, 2008; searched January 2, 2009
- United States Adopted Names (USAN) at http://search.ama-assn.org, updated December 4, 2008; January 2, 2009
- NDC Trade Name, http://www.fda.gov/cder/ndc/database/, current through December 3, 2008; searched January 2, 2009
- http://cdspoca.cder.fda.gov/POCA/search.aspx, searched January 2, 2009