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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Mid-Cycle Meeting Minutes - Atryn

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

  1. There were no major issues noted at this time for all disciplines.
  2. 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).
  3. The established name will be recommended to change from antithrombin alfa to antithrombin III (Recombinant) to comply with the nomenclature used by CBER/OBRR.
  4. We also filled the OBRR Mid-Cycle Review Checklist form and following items were checked in the form.
    1. Proprietary Name review has been submitted and found acceptable, 3/7/08
    2. BPAC is planned for January 9, 2009.
    3. Lot Release is not required
    4. Post Marketing requirements (PMR) is planned to be requested.
  5. The review committee was notified of the new midcycle memo due date of October 15, 2008.