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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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PNR Unacceptable Letter - Kcentra

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


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

 

Our STN: 125421/0                                                                          
 
CSL Behring GmbH
Attention: Paula Hines, Ph.D.
1020 First Avenue, P.O. Box 61501
King of Prussia, PA  19406-0901
                         
Dear Dr. Hines:
 
We have reviewed your submission dated March 30, 2012 to your biologics license application (BLA) for Prothrombin Complex Concentrate (Human) requesting a proprietary name review. 
  
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB), we conclude that your proposed proprietary names, BERIPLEX and ---(b)(4)---, are unacceptable under the Federal Food, Drug, and Cosmetic Act and applicable regulations.
 
You may submit a new proprietary name for FDA consideration.  Please request in writing the review of any alternative name.  An alternative name should comply with the regulations regarding false, misleading or fanciful names.
 
The proposed proprietary names are considered false or misleading and/or fanciful.
 
The bases for our decision are:
 
1.   Your proposed name BERIPLEX might be confused with other medicinal products with orthographic or phonological similarities within the meaning of 21 CFR 201.10(c)(5), such as Periflex, Berinert, etc. Of particular concern is the potential for medication errors between Berinert and BERIPLEX.  These two proposed proprietary names share two prominent initial syllables. Prescribers may verbally communicate an order and the last syllables may not be clearly pronounced or “heard” either actively or passively. Berinert and BERIPLEX share dosage formulation, dosage strength per vial, method of administration, storage setting, and inpatient use environment.
 
2.   Your alternative proposed name ---(b)(4)--- is considered fanciful within the meaning of 21 CFR 201.10(c)(3).  The proposed alternative proprietary name, ---(b)(4)---, may be regarded as misleading and fanciful. Specifically, the first syllable, “(b)(4),” refers to the term “rapid,” implying that the product is rapid acting or has a rapid effect for the reversal of acute major bleeding. Rapid is a vague and misleading adjective in the absence of quantitative information.
 
You may submit a new proprietary name for FDA consideration. 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.
 
If you have any questions, please contact Beth Walton at (301) 827-3762.
 
 
Sincerely yours,
 
 
 /s/
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research