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Vaccines, Blood & Biologics

Proprietary Name Review Letter - Flucelvax

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service


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


Our STN: BL 125408/0                                                                    
Novartis Vaccines and Diagnostics, Inc.
Attention: Matthew Gollwitzer
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue
Cambridge, MA 02139
Dear Mr. Gollwitzer:
We have reviewed your submission dated March 16, 2012, to your biologics license application (BLA) for Influenza Vaccine (MDCK Cells) requesting a proprietary name review. 
We have consulted with CBER’s Advertising and Promotional Labeling Branch (APLB) which recommends that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, OPTAFLU, be deemed unacceptable. 
The proposed proprietary name is considered misleading.
The basis for our decision is:
Your proposed name is considered misleading within the meaning of 21 U.S.C. 352(a) and 321(n). (See also 21 CFR 201.10(c)(3)) Specifically, the proposed proprietary name, Optaflu, is misleading because the morpheme, “Opta,” implies superiority (e.g., optimum or optimal). In addition, the morpheme, “Opta,” may be a source of medication errors because it is commonly used as a prefix for ophthalmic medicines.
You may submit a new proprietary name for FDA consideration. Any alternative proprietary name(s) should comply with the regulations regarding false, misleading or fanciful names and should not be confused with other medicinal products with orthographic or phonological similarities.
If you have any questions, please contact Dr. Brenda Baldwin or Dr. Timothy Fritz at
(301) 796-2640.
Sincerely yours,
Wellington Sun, M.D.
Division of Vaccines and
 Related Product Applications
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research

Page Last Updated: 12/19/2012
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