Food and Drug Administration

Boold Products Advisory Committee

September 29, 2005


Topic I


Exjade® (deferasirox; ICL670) Introduction, PK Narang, PhD, FCP (HTM) (PPT)

Iron Overload: Complications and Need for Therapy, John Porter, MD (HTM) (PPT)

Efficacy and Safety, Peter Marks, MD (HTM) (PPT)

Conclusions on Benefit and Risk, Elliott Vichinsky, MD (HTM) (PPT)


Presentation by George Shashaty, MD (HTM) (PPT)

Topic II

Site Visit Review of the Division of Hematology Laboratories, Hira Nakhasi, PhD (HTM) (PPT)

Division of Hematology, Basil Golding, MD (HTM) (PPT)

Site Visit Presentation, February 25, 2005, Basil Golding, MD (HTM) (PPT)

BPAC Site Visit Report Presentation (HTM) (PPT)

Laboratory of Plasma Derivatives Safety and Quality Control Section, Mei-ying Yu, PhD (HTM) (PPT)

LH/Q3012R Molecular Biology, Immunology, & Genetics of Coagulation Factors, Jay Lozier, MD, PhD (HTM) (PPT)

Open Public Hearing

Presentation by Lynn Amer (PDF)

Petition Re: NDA for Exjade (PDF)