
 

 

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
    
 
  


Re-evaluation of proposed proprietary name ATryn




  Share


  Tweet


  Linkedin


  Pin it

  More sharing options 
    Linkedin


    Pin it



  Email


  Print

 
Memorandum

Date: November 18, 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 

Subject: Re-evaluation of proposed proprietary name ATryn (Antithrombin alfa) 
BLA STN 125284/0 

Recommendation: Proposed proprietary name ATryn is Acceptable with concerns. 

Executive Summary:

APLB found that no new information has been presented that would change our 
previous recommendation of Acceptable with concerns. Therefore, we recommend 
that the proposed proprietary name ATryn be found Acceptable with concerns. The 
approval date is February the 7, 2009.

Proposed Proprietary Name Evaluation:

APLB performed a re-evaluation of the proposed proprietary name, ATryn , to 
determine if the proposed name could be considered false, misleading, or 
fanciful since our previous review on March 7, 2008. APLB re-reviewed the 
proprietary name because substantial time had passed since our last review and 
to ensure that there are no newly marketed product whose name resembled Atryn 
within 90 days of approval.

Recommendation:

No newly approved products whose name resembled ATryn were found. APLB 
recommends that the proposed proprietary name ATryn be found Acceptable with 
concerns, which is consistent with our March 7, 2008 review memo.

If you have any questions regarding this review, please contact Maryann 
Gallagher at 301-827-6330.
 

   
 


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


 