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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Unacceptable Proposed Name, May 1, 2009 - Adenovirus

Our STN:  BL 125296/0

Duramed Research, Inc.
Attention:  Joseph A. Carrado
One Belmont Avenue, 11th Floor
Bala Cynwyd, PA  19004

Dear Mr. Carrado:

We have reviewed your submission dated February 19, 2009, to your biologics license application (BLA) for Adenovirus Type 4 and Type 7 Vaccines, Live, Oral requesting a proprietary name review. 

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed name, ---(b)(4)--- is unacceptable. 

Our decision is based on the following:

1.         Your proposed name is considered fanciful within the meaning of 21 CFR 201.10(c)(3). 

You state that ----(b)(4)--- is comprised of (b)(4) for adenovirus and --(b)(4)-- as the second syllable of the word “defend.”  However, in an etymological view of ---(b)(4)---, the syllable “a” means (Latin) “to” and “defend” means “to drive danger or attack away.”  The “defend” portion of the name implies a guarantee to “defend” a person from anything, not just adenovirus.  As a whole, the proprietary name can also be interpreted as fending off any danger.  In addition, the first letter “A” in ---(b)(4)---  may sound like a verbal hesitation and could be confused with names that sound like “DEPEND.”

2.         Your proposed name might be confused with other medicinal products with orthographic or phonological similarities within the meaning of 21 CFR 201.10(c)(5). 

Since drug products are prescribed through written, verbal, and /or electronic orders, similarity in spelling or pronunciation via such forms of communication may lead to medication errors.  Even when proprietary names are only slightly similar, overlapping product characteristics may contribute to a greater potential for confusion.

APLB identifies a high potential for medication error due to similarity in spelling and pronunciation between ---(b)(4)--- and other marketed products.  Some of the marketed products whose names share many phonetic and orthographic similarities to ---(b)(4)--- include Ativan (lorazepam), Atacand (candesartan), Actifed (pseudoepinephrine containing cough, cold and allergy products), Acephen (acetaminophen), Vfend (voriconazole), Adphen (phendimetrazine), Emend (aprepitant/fosaprepitant), Adagen (pegademase bovine).

Since you submitted two proprietary names, you may submit a request to review the second proposed name, ---(b)(4)---, at this time.  You may also submit a new proprietary name for FDA consideration.  However, if you choose to forego the use of a proprietary name, please submit a withdrawal of the ---(b)(4)--- name and inform us of your decision to use only the proper name in writing.  Any alternate 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.  Please include with your submission corrected cartons, containers and labeling package inserts so that the labeling review can continue. 

If you have any questions, please contact Ms. Darlene Hithe at (301) 827-3070.

Sincerely yours,

/signature/

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