Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
Advertising and Promotional Labeling Branch
Date: October 20, 2009
To: Bernard McWatters, Committee Chair, OVRR, DVRPA, CMC1 (HFM-478)
Anissa Cheung, Regulatory Project Manager, OVRR/DVP (HFM-445)
From: Lisa Stockbridge, Ph.D., CSO, OCBQ/DCM/APLB (HFM-602)
Through: Ele Ibarra-Pratt, RN, MPH, Branch Chief, OCBQ/DCM/APLB (HFM-602)
Subject: Re-evaluation of the proposed name Agriflu BLA 125297
Agriflu [Influenza virus trivalent subunit (A/A/B hemagglutinin and neuraminidase; embryonated hen’s eggs) Vaccine, Inactivated] is a seasonal flu vaccine that will be provided by Novartis. The Advertising and Promotional Labeling Branch (APLB) performed its initial proprietary name review (PNR) on May 13, 2009, and found Agriflu to be acceptable at that time. A re-evaluation of the proposed proprietary name is performed within 90 days of approval to ensure that there have not been any new products approved since the initial PNR that would have the potential to cause medical errors due to sound-alike or look-alike properties. Following re-evaluation, APLB has found no reason to change our original recommendation that Agriflu be deemed ACCEPTABLE.
Proposed Proprietary Name Re-evaluation
Reference is made to the May 13, 2009, PNR in which APLB found the name, Agriflu, to be acceptable. Although APLB recognized that Ak-flour and Aquaphor, as well as some flu products (i.e., Afluria and Tamiflu), had similar pronunciation and spelling, we determined that the risk for medication errors was mitigated by indication, dosage form, storage, route of administration, and usage. Furthermore, health care professionals usually stock only one brand of influenza vaccine, reducing the potential for confusion with other influenza vaccines at point of administration.
APLB has re-reviewed the proprietary name because substantial time has passed since the initial PNR. This re-evaluation, within 90 days of approval, ensures that there are no newly marketed products deemed to pose potential confusion with Agriflu.
- http://dailymed.nlm.nih.gov/dailymed (accessed October 19, 2009)
- http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (CDER New and Generic Drug; accessed October 19, 2009)
- http://www.fda.gov/BiologicsBloodVaccines (CBER approvals; accessed October 19, 2009)