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Re-evaluation of proposed proprietary name ATryn




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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.
 

   
 


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  Approval History, Letters, Reviews and Related Documents - ATryn	[ARCHIVED] 
  ATryn 
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