Oncologic Drugs Advisory Committee: October 6, 2009

FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee

AGENDA
October 6, 2009
Page 1 of 1
8:00 a.m. Call to Order
Introduction of Committee Chair, ODAC
Conflict of Interest Statement Nicole Vesely, Pharm.D.
Designated Federal Official, ODAC
The committee will discuss new drug application (NDA) 021–825, with the proposed trade name FERRIPROX (deferiprone) film-coated tablets, manufactured by ApoPharma Inc. This product is an iron chelating agent, which is a drug that binds with iron in the body and helps to make elimination of iron easier, reducing iron build-up. There are two specific proposed indications (uses) of FERRIPROX: (1) For the treatment of iron overload, or build-up in patients with transfusion-dependent thalassemia, an inherited blood disorder that necessitates frequent transfusion of normal blood which can lead to iron build-up due to the iron content in the blood a patient receives; and (2) for the treatment of iron overload in patients with other transfusion-dependent anemias (other blood disorders that require frequent transfusions) for whom the use of other iron chelating agents has been considered inappropriate.

abrir aquí:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM182439.pdf