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Mid-Cycle Meeting Minutes - Atryn




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Memorandum

Date: October 8, 2008  

From: Pratibha Rana 

To: STN 125284/0 

Re: Mid-Cycle Meeting Minutes 


Date: October 8, 2008

Location: WOC, 300N

Time: 10:00 am-11:30am

Attendees: Iftekhar Mahmood, Joseph Manik, Faith Barash, Chiang Syin, Evi 
Struble, Paul Hshieh, Nisha Jain, Roman Drews, Robert Wise, Jeffrey Anderson, 
Pratibha Rana
  There were no major issues noted at this time for all disciplines.
  Regarding the labeling the following information will be requested: In order 
    to support your claim “clearance and volume of distribution are 
    significantly increased in pregnant patients as compared to non-pregnant 
    patients". Please provide PK data to the FDA for both pregnant and 
    non-pregnant women for comparison purposes. The data should consists of age, 
    weight, dose, plasma concentrations vs time data, and estimated PK 
    parameters in these subjects (pregnant and non-pregnant women).

  The established name will be recommended to change from antithrombin alfa to 
  antithrombin III (Recombinant) to comply with the nomenclature used by 
  CBER/OBRR.
  We also filled the OBRR Mid-Cycle Review Checklist form and following items 
  were checked in the form. Proprietary Name review has been submitted and 
    found acceptable, 3/7/08
    BPAC is planned for January 9, 2009.
    Lot Release is not required
    Post Marketing requirements (PMR) is planned to be requested.

  The review committee was notified of the new midcycle memo due date of October 
  15, 2008.
 

 


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