Up | AC
Home Page
Food and
Drug Administration
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)