
 

 

HHS 
U.S. Department of Health and Human Services
   



U.S. Food and Drug Administration 
  



  A to Z Index


  Follow FDA


  En Español

 



Search FDA  Submit search  

                

 

  Popular Content


  Home


  Food


  Drugs


  Medical Devices


  Radiation-Emitting Products


  Vaccines, Blood & Biologics


  Animal & Veterinary


  Cosmetics


  Tobacco Products

    





Archived Content

The content on this page is provided for reference purposes only. This content 
has not been altered or updated since it was archived.



Search Archive  Submit archive search  
       
 

Vaccines, Blood & Biologics
  
    
  
  Home
   Vaccines, Blood & Biologics
   Blood & Blood Products
   Approved Products
    Licensed Products (BLAs)
  	 Fractionated Plasma Products
    
 
  


Review of proposed proprietary name ATryn




  Share


  Tweet


  Linkedin


  Pin it

  More sharing options 
    Linkedin


    Pin it



  Email


  Print

 
Memorandum

Date: March 7, 2008  

To: Nisha Jain, OBRR/DH/LBVB, HFM-343
 Pratibha Rana, OBRR/DBA/RPMB, HFM-380 

From: Maryann Gallagher, Consumer Safety Officer
 Advertising and Promotional Labeling Branch (APLB)
 Division of Case Management (DCM), HFM-602 

Though: Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, DCM, HFM-602
 Robert A. Sausville, Director, DCM, HFM-610 

Subject: Review of proposed proprietary name ATryn (Antithrombin alfa)
 (BB-IND -b(4)-) , STN 125284/0 

Executive Summary:

APLB recommends that the proposed proprietary name ATryn be found Acceptable 
with concerns.

Background:

On August 9, 2007, GTC Biotherapeutics submitted a pre-BLA Information Package 
for ATryn (antithrombin alfa), which included a request to review their proposed 
proprietary name. The submission was received in the CBER Document Control Room 
on August 9, 2007 and in APLB on October 2, 2007.

ATryn® has been registered as a trademark with the U.S. Patent and Trademark 
Office since April 9, 2002.

Overview of the Proposed Indication, Dose, Dosage Form, Administration, and 
Storage Information:

ATryn is designated as an orphan drug for the treatment of patients with 
hereditary antithrombin deficiency. The proposed indication for ATryn is for the 
prevention of peri-operative and peri-partum thromboembolic events, as well as 
the treatment of patients with hereditary antithrombin deficiency during 
surgical or obstetrical procedures to reduce the risk of thromboembolism. ATryn 
is a lyophilized powder containing nominally 1750 IU antithrombin alfa per vial. 
A vial of lyophilized ATryn is reconstituted with 10mL of Sterile Water for 
Injection (WFI) to provide approximately a 175 IU/mL solution, which is intended 
for intravenous infusion. The reconstituted product may be diluted further with 
0.9% sodium chloride solution to desired antithrombin concentration and added to 
an IV infusion bag or infusion pump for intravenous infusion. The loading dose 
will be determined on an individual basis depending upon patient pre-treatment 
AT activity levels, patient body weight and taking into consideration usage of 
concomitant medications. Likewise, the dose for continuous infusion will be 
based upon patient pre-treatment AT activity level and body weight. Dosage 
during continuous infusion may be adjusted based upon rate of consumption and 
medical conditions. Dose adjustments may be made by administration of a short 
bolus dose or by increasing the rate of continuous infusion. Therapeutic drug 
monitoring recommendations will be made in the proposed package insert based 
upon recommendations used in clinical trials.

The lyophilized kit may be stored in a refrigerator (2°-8°C). ATryn will be 
provided as a sterile lyophilized product packaged in 20mL glass vials. ATryn 
should be reconstituted and administered within 12 hours in the hospital.

The company’s rationale for selecting the proposed proprietary name ATryn:

AT is a common abbreviation for the active moiety (antithrombin)
 Try means three to represent the active moiety antithrombin III.

GTC Biotherapeutics had a full pharmaceutical trademark research study carried 
out by --b(4)-----------------, to ensure that the proposed tradename ATryn has 
not already been chosen for a product and to ensure that there are no 
sound-alike or look-alike names. GTC Biotherapeutics is in the process of 
updating their search by using the reference texts listed in Appendix 2 in the 
FDA SOPP 8001.4, to further evaluate their proposed proprietary name. The study 
will be submitted upon completion.

Proposed Proprietary Name Evaluation:
  False or Misleading [21 CFR 201.6 (a)]:
   The proposed proprietary name ATryn is not regarded to be false or 
misleading.
  Fanciful [21CFR 201.10 (c)(3)]:
   The proposed proprietary name ATryn is not regarded to be fanciful. It does 
  not appear to imply that the drug or ingredient has some unique effectiveness 
  or composition beyond that supported by the data.
  Similarity in Spelling or Pronunciation [21 CFR 201.10 (c) (5)]:
   Drug products are prescribed through written, verbal, and /or electronic 
  orders. Such forms of communication may lead to medication errors, 
  particularly if proprietary and /or established names sound or look alike. 
  Even when proprietary names are only slightly similar, overlapping product 
  characteristics may create a greater potential for confusion. Atropine may 
    be confused with the proprietary name ATryn because the first three letters 
    (Atr) could be potentially confused with the first three letters in ATryn in 
    verbal orders but Atropine has 3 syllables and ATryn has 2 syllables. In 
    addition, Atropine and ATryn have different indications, i.e. Atropine is an 
    anticholinergic used as a premedication for anaesthesia, to treat 
    bradycardias, and during reversal of neuromuscular blockade in adults. 
    Atropine will be stored at room temperature in all hospital pharmacies; 
    however, ATryn will be stored refrigerated and because it is an orphan drug, 
    it will not be routinely stored in all pharmacies. Therefore, this may 
    minimize the risk of medication error between ATryn and Atropine. However, 
    both products may be used under similar settings and surgical procedures, 
    which may increase the risk for medication error.
    Afrin may be confused with the proprietary name ATryn because of similarity 
    in spelling, pronunciation, and handwriting. Afrin and ATryn have different 
    indications and Afrin is an over the counter drug and does not require a 
    prescription. ATryn is an orphan drug available by prescription for a 
    specific indication and population, and will not be routinely stored in all 
    pharmacies. Therefore, there the risk of medication error between ATryn and 
    Afrin is minimized.


Recommendations for proposed name:

APLB recommends that the proposed proprietary name ATryn be found acceptable 
with concerns. There appears to be a minimal risk for medication errors with the 
proprietary names for other marketed products taking into account similarity in 
spelling, therapeutics class, indication, pronunciation, handwriting and 
marketing status. If OBRR accepts our recommendation that the proposed 
proprietary name ATryn be found acceptable with concerns, please include the 
following text in your letter to the manufacturer:


We have considered your proposed proprietary name ATryn in consultation with 
CBER’s Advertising and Promotional Labeling Branch (APLB) and conclude that 
under 21 CFR Part 201 the proposed proprietary name is acceptable at this time.

You should request another proprietary name review of ATryn closer to the time 
of approval since a significant amount of time may pass between now and 
licensure of the product and to ensure that FDA has not approved a product with 
a conflicting proprietary name in the interim.

If you have any questions regarding this review, please contact Maryann 
Gallagher at 301-827-3028.

The following references were used:
  http: //www.thomsonhc.com/pdrel/librarian (Electronic Physicians’ Desk 
  Reference 2007)
  http://www.factsandcomparisons.com (Drug Facts and Comparisons)
  http:// www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (CDERNew and 
  Generic Drug Approvals through October 31, 2007)
  http://www.fda.gov/cder/ob (Electronic Orange Book through October 17, 2007)
  http://www.rxlist.com (RxList)
  http://www.fda.gov/cber/products/htm (CBER New BLA, 510 (k) Devices, NDA and 
  PMA approvals lists through October 31, 2007)
  http://www.ama-assn.org/ama/pub (American Medical Association Website-Newly 
  Approved USAN stems through October 5, 2007
  http: //www.acronymfinder.com
  2007 American Drug Index.
 

 


Key Resources

  Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) 
   
 


More inFractionated Plasma Products
   


Resources for You

  Approval History, Letters, Reviews and Related Documents - ATryn	[ARCHIVED] 
  ATryn 
 var maincontentcss = document.getElementById("middle_js"); if(maincontentcss) {
 maincontentcss.style.width = "71%"; }       


   Page Last Updated: 08/10/2015  
 Note: If you need help accessing information in different file formats, see 
Instructions for Downloading Viewers and Players.
 Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | 
Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | 
Deutsch | 日本語 | فارسی | English	 




FDA


  Accessibility


  Careers


  FDA Basics


  FOIA


  No FEAR Act


  Site Map


  Nondiscrimination


  Website Policies

 




U.S. Food and Drug Administration
 10903 New Hampshire Avenue
 Silver Spring, MD 20993
 1-888-INFO-FDA (1-888-463-6332)
Contact FDA 

Subscribe to FDA RSS feeds Follow FDA on Twitter Follow FDA on Facebook View FDA 
videos on YouTube View FDA photos on Flickr 


   FDA Archive


   Combination Products


   Advisory Committees


   Regulatory Information


   Safety



   Emergency Preparedness


   International Programs


   News & Events


   Training & Continuing Education


   Inspections & Compliance



   Federal, State & Local Officials


   Consumers


   Health Professionals


   Science & Research


   Industry

 

Scroll back to top 
     


Popular Content

  Home

   
  Latest Recalls

   
  Report an Adverse Event

   
  MedWatch Safety Alerts


  News Releases


  Consumer Updates


  About FDA


  Contact FDA


  Browse by Product Area


  Product Areas

  back

    Food


    Drugs


    Medical Devices


    Radiation-Emitting Products


    Vaccines, Blood & Biologics


    Animal & Veterinary


    Cosmetics


    Tobacco Products

