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Vaccines

Review of Proposed Proprietary Name Memo, October 20, 2009 - MenHibrix

Date:      October 20, 2009
From: Maryann Gallagher, Consumer Safety Officer
OCBQ/DCM/APLB, HFM-602
Through:   

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

Robert A. Sausville
Director, DCM

To: Joseph Temenak, Primary Reviewer, OVRR/DVRPA
Jennifer Bridgewater, RPM, OVRR/DVRPA/VCTB
Meghan Ferris, MD, OVRR/DVRPA/VCTB
Subject:

Review of proposed proprietary name MENHIBRIX
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
STN 125363

Recommendation:Menhibrix proprietary name found Acceptable with concerns
**Note:    This review contains proprietary and confidential information
regarding Menveo that should not be released to the public.**

Executive Summary:

APLB has completed the proprietary name review (PNR) for the proposed proprietary name Menhibrix.  We recommend that Menhibrix be found Acceptable with concerns. 

According to SOPP 8001.4 (Review of CBER Regulated Product Proprietary Names), OVRR makes the final decision on the acceptability of Menhibrix and, to meet the PDUFA IV performance goal, communicates this decision to Glaxo Smithkline (GSK) within 90 days of the receipt of the complete PNR submission.  The PDUFA goal date for this PNR is November 10, 2009.

If OVRR accepts our recommendation that the proposed proprietary name Menhibrix be found Acceptable with Concerns, please include the following text in your letter to the sponsor:
In consultation with CBER’s Advertising and Promotional Labeling Branch we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name Menhibrix is acceptable with concerns at this time.  There is a potential risk for medication error with Menomune and

Menactra; however, these risks may be minimized by including the indicated age group i.e., “For 6 weeks through 15 months of age” and the route of administration, on the container and package labeling with sufficient prominence to help reduce confusion among these products.

OVRR is responsible for communicating CBER’s decision to GSK and should enter the communication issuance date into RMS BLA before November 10, 2009, in order to stop the performance clock. Please notify APLB when this action has been completed. 

Background:

Please refer to APLB’s review memo dated October 22, 2008, in response to GSK’s initial request for review of the proposed proprietary name on April 7, 2008.  Some concerns included:

  • There are currently 2 licensed meningococcal vaccines, Menomune and Menactra and Menveo is pending approval February 10, 2010.
  • There are currently 3 licensed Haemophilus vaccines, ActHib, Pedvax Hib, and Hibtiter.
  • APLB identified Menomune, Menactra, Menveo** as having some similar written appearance to Menhibrix. 
  • Menhibrix, Menomune, Menactra, and Menveo**share many product characteristics: including indication and usage, dosage and administration, dosage forms and strengths, storage temperature, and location.

On August 12, 2009, GSK submitted a request for review of the proposed proprietary name Menhibrix, for their Meningococcal C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine to BLA 125363.

There was one newly marketed product Hiberix (approved August 19, 2009) that resembles Menhiberix.  However, Hiberix is a  Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), indicated for active immunization as a booster dose in children 15 months through 4 years (prior to fifth birthday). While there is a potential for confusion, Hiberix has a different indication and age group than Menhibrix.

On September 17, 2009, the Office of Biostatistics and Epidemiology/Division of Epidemiology/Vaccine Safety Branch provided VAERS reports of Menactra and Menomune errors.  There had been 10 reports of Menactra being administered to either individuals who were less than 2 (7 reports) or older than 55 years of age (3 reports). 

The Medical Officer assigned to this application was consulted, and she had no concerns regarding the name, Menhibrix.

Recommendation:

APLB recommends that the proposed proprietary name Menhibrix be found Acceptable with Concerns.  There is a potential risk that Menhibrix, Menveo**, Menomune, and Menactra may be mixed up, thereby causing medication errors.  Therefore, we recommend that the packaging be sufficiently distinct from Menveo, Menomune and Menactra, and that the indicated age group i.e., “For 6 weeks through 15 months of age” and the route of administration be presented with sufficient prominence to help reduce confusion among these products.

If OVRR accepts our recommendations that the proposed proprietary name Menhibrix be found Acceptable with Concerns, please include the following text in your letter to the manufacturer:

In consultation with CBER’s Advertising and Promotional Labeling Branch we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name Menhibrix is acceptable with concerns at this time.  There is a potential risk for medication error with Menomune and Menactra; however, these risks may be minimized by including the indicated age group i.e., “For 6 weeks through 15 months of age” and the route of administration, on the container and package labeling with sufficient prominence to help reduce confusion among these products.

References:
Abbreviations at http://www.medilexicon.com/
Facts & Comparisons 4.0 at online.factsandcomparisons.com
Drugs@FDA at www.accessdata.fda.gov
USPTO Patent Full-Text and Image Database at patft1.uspto.gov
Electronic Orange Book at http://www.fda.gov/cder/ob/default.htm, current through May 2008
RxList at www.rxlist.com
Thomson Micromedex
USAN Stem http://www.ama-assn.org/ama1/pub/upload/mm/365/stem_list_3-6-08.pdf
FDA’s Phonetic and Orthographic Computer Analysis
Google http://www.google.com

If you have any questions with regards to this review please contact Maryann Gallagher, Consumer Safety Officer at 301-827-6330.