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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 11, 2009

Rana, Pratibha


From: Stockbridge, Lisa L
Sent: Thursday, June 11, 2009 10:47 AM
To: Rana, Pratibha; Zhang, Pei; Hu, Jiang; Tanksley, Sarah; Kannan, Bhanu; Ko, Hon Sum;
Mahmood, Iftekhar; QuanderIII, Joseph; Struble, Evi; Trout, Deborah; Virata, Maria Luisa;
Zhong, Lilin; Frazier, Douglas; Fisher, Robert
Cc: Anderson, Jeffrey; Jain, Nisha
Subject: RE: Filing Meeting /STN125350/0/CSL/Pratibha

Pratibha,

This application is fileable from APLB's perspective.

Please let the sponsor know that "Hizentra" is acceptable at this point. (There will be a re-evaluation 90 days from BLA
approval. The sponsor is not required to do anything more concerning the re-evaluation --- we do that here.) Also, please
be sure to close out the milestone for the PNR.

Thanks,

LLS


From: Rana, Pratibha
Sent: Wednesday, June 10, 2009 4:22 PM
To: Zhang, Pei; Hu, Jiang; Tanksley, Sarah; Kannan, Bhanu; Ko, Hon Sum; Mahmood, Iftekhar; QuanderIII, Joseph; Stockbridge, Lisa L;
Struble, Evi; Trout, Deborah; Virata, Maria Luisa; Zhong, Lilin; Frazier, Douglas; Fisher, Robert
Cc: Anderson, Jeffrey; Jain, Nisha
Subject: Filing Meeting /STN125350/0/CSL/Pratibha

Hello All,

Please enter a filing memo or send me an email stating this BLA is fileable.
Sara T has already entered her memo. If all of you agree that this is fileable and if there are no issues to discuss then we
can cancel the filing meeting. But if there are issues we want to discuss then we should definitely meet tomorrow.
Pratibha

Pratibha Rana, M.S.
Regulatory Project Manager

FDA/CBER/OBRR
Division of Blood Applications
1401 Rockville Pike
Rockville, MD 20852
Office: (301) 827-6124
Fax: (301) 827-2857
email: pratibha.rana@fda.hhs.gov

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