October 6, 2009: Amendment to the Oncologic Drugs Advisory Committee Meeting Announcement
Federal Register Notice Amendment (dated September 9, 2009) to the Federal Register Meeting Notice of the Oncologic Drugs Advisory Committee
|CDER||October 6, 2009
||8:00 a.m. - 4:00 p.m.
||Hilton Washington DC North/Gaithersburg
620 Perry Parkway
On September 9, 2009, an amendment to the Oncologic Drugs Advisory Committee meeting notice, originally published in the Federal Register of August 25, 2009, was made. The amendment was made to reflect a change in the Agenda portion of the meeting announcement. There are no other changes.
SUPPLEMENTARY INFORMATION: In the FEDERAL REGISTER of August 25, 2009, FDA announced that a meeting of the Oncologic Drugs Advisory Committee would be held on October 6, 2009. On page 42907, in the second column, the Agenda portion of the document is changed to read as follows:
Agenda: 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.