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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BLA Filing Meeting Memo - CINRYZE

Filing Meeting Summary

Date: September 13, 2007           Time: 10:30 AM

From: Nannette Cagungun

To: STN 125267/0

Re: Filing Meeting for LevPharma’s C1 Esterase Inhibitor BLA

________________________________________________________________________

CBER Participants:

Nannette Cagungun
Paul Buehler
Omer Butt
Felice D’Agnillo
Dave Doleski - Absent
Mahmood Farshid – Absent
Iftekhar Mahmood
Elena Karnaukhova - Absent
Charles Maplethorpe
Jean Mackie
Robert Wesley - Absent
Boris Zaslavsky -

Discussion:

The review committee members recommended that the BLA be filed with the exception of the clinical reviewer who expressed some concerns regarding the filing suitability of the application. His recommendations will be presented to the acting division director.

BIMO and DMPQ reviwers will be contacted to determine if inspection plans have been made. Joseph Quander will also be contacted regarding specifics on lot release.

Post Meeting Note: A decision was reached in consultation with the acting division director to file the BLA application. A Filing Letter will be issued on or before the action due date of 28 September 2007.