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  Blood Products Advisory Committee

May 2, 2008

BRIEFING INFORMATION

May 2, 2008  Topic II: Lev Pharmaceuticals, Inc. Background Package

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Item 1:    Background Package (pdf)

Item 1E:  Errata for page 47 Background Package (pdf)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

May 2, 2008 Topic II: FDA Issue Summary: Lev Pharmaceuticals, Inc. Clinical Trial for
the Use of Plasma-Derived C1 Esterase Inhibitor (Cinryze) for the
Prophylaxis of Hereditary Angioedema Attacks

Item 1:  Original FDA Briefing Document - CinryzeTM C1-esterase Inhibitor (Human)
Nanofiltered (C1 INH-nf), Lev Pharmaceuticals, Inc. (htm)

Item 2:  Revised FDA Briefing Document - CinryzeTM C1-esterase Inhibitor (Human)
Nanofiltered (C1 INH-nf), Lev Pharmaceuticals, Inc. (htm)

Item 3:  Errata – FDA Briefing Document – CinryzeTM C1-esterase Inhibitor (Human) Nanofiltered (C1 INH-nf), Lev Pharmaceuticals, Inc. (htm)

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