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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Proprietary Name Review Letter - MenHibrix

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                
Public Health Service


                                                                                                                                                         
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Our STN: BL 125363/0                                                                      

GlaxoSmithKline Biologicals
Attention:  Jody Gould, Ph.D.
2301 Renaissance Blvd.
P.O. Box 61540
King of Prussia, PA 19406

Dear Dr. Gould:

We have reviewed the request for proprietary name review in your Biologics License Application (BLA) submitted August 12, 2009, for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine.

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.

We will perform another proprietary name review of MenHibrix® closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.

If you have any questions, please contact LCDR Jason Humbert at (301) 827-3070.

Sincerely yours,

/s/

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research