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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1/11/2008 Email - XYNTHA

From: Lee, Timothy
Sent: Friday, January 11, 2008 10:37 AM
To: Cottrell, Pauline
Subject: FW: Sign off for Lot Release of STN 125264: Wyeth's BLA for Recombinant AHF [Xyntha]

Hello, Pauline,

Please keep this email as a record that Lot Release Testing is complete.

Thank you.

Tim

_________________________________

 

From: Dougherty, Suanne
Sent: Friday, January 11, 2008 10:11 AM
To: Lee, Timothy
Cc: QuanderIII, Joseph; Wood, Laura
Subject: RE: Sign off for Lot Release of STN 125264: Wyeth's BLA for Recombinant AHF [Xyntha]

Dr Lee,

I checked our records and it appears that all requested sample testing and protocol review, on the three lots (53526, 66518, 66519) associated with STN 125264/0, is complete.

The TR will remain for "Release Action" until the Licensing Action for 125264/0 has been approved, but it does not appear that any additional information is needed for PRB sign off on this file.

Sue Dougherty
Consumer Safety Officer
CBER/OCBQ/DMPQ/PRB

_________________________________

 

From: Lee, Timothy
Sent: Friday, January 11, 2008 8:11 AM
To: Dougherty, Suanne
Subject: FW: Sign off for Lot Release of STN 125264: Wyeth's BLA for Recombinant AHF [Xyntha]

Good morning, Sue,

Would you kindly help me with my request to Joe?

Thank you.

Tim

_________________________________

 

From: Lee, Timothy
Sent: Friday, January 11, 2008 8:09 AM
To: QuanderIII, Joseph
Cc: Wood, Laura
Subject: Sign off for Lot Release of STN 125264: Wyeth's BLA for Recombinant AHF [Xyntha]

Good morning, Joe,

Laura Wood has informed me that she had tested the conformance lots for this BLA and signed off in the system. However, for "Release Action", it still says TR (to be returned) dated 2 October. Please let me know what additional information you need for you to sign off on this file.

The action due date for this BLA is 22 February 2008.

Thank you.

Tim