Date: November 18, 2008
Nisha Jain, OBRR/DH/LBVB, HFM-343
Pratibha Rana, OBRR/DBA/RPMB, HFM-380
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.
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.
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.