Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Date: April 10, 2012
From: Maryann Gallagher
Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Division of Case Management (DCM)
Through: Lisa L. Stockbridge, Ph.D.
To: Joseph Temenak, Chairperson, OVRR/DVRPA/CMC3
David Staten, RPM, OVRR/DVRPA/CMC3
Kirk Prutzman, RPM, OVRR/DVRPA/CMC3
Subject: Re-evaluation of proposed proprietary name MENHIBRIX
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Recommendation: MENHIBRIX proprietary name found Acceptable.
APLB has performed a re-evaluation of the proposed proprietary name MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) to determine if any new products whose names resemble MENHIBRIX have been approved since our previous reviews on October 22, 2008 and July 25, 2011. APLB found that no new products were approved that would change our previous recommendation. APLB recommends that the proposed proprietary name, MENHIBRIX, be found Acceptable.
APLB re-reviewed the proprietary name to ensure that our review is within 90 days of approval. The PDUFA goal date for this product is June 1, 2012. There are no new marketed products whose name resembles MENHIBRIX.
APLB recommends that the proposed proprietary name, MENHIBRIX, be found acceptable. There is a potential risk for medication error with Menveo, Menomune, and Menactra; however, this risk may be minimized by providing packaging that will differentiate MENHIBRIX from Menveo, Menomune, and Menactra. See APLB’s memos on October 22, 2008, October 20, 2009, July 25, 2011, and March 30, 2012.
If you have any questions concerning this review, please contact Maryann Gallagher, Consumer Safety Officer at 301-827-6330.
CBER BLA approval list, updated March 9, 2012
CBER NDA and ANDA approval list, updated September 30, 2011
CDER New Drug Approvals, updated March 31, 2012