October 6, 2009: Oncologic Drugs Advisory Committee Meeting Announcement
|CDER||October 6, 2009||8:00 a.m. - 4:00 p.m.||Hilton Washington DC North/Gaithersburg|
620 Perry Parkway
|The October 6, 2009, ODAC meeting has been cancelled to allow time for the FDA to review and resolve several outstanding issues. The Agency intends to continue evaluating NDA 021-825 and, as needed, may schedule an Advisory Committee meeting in the future.|
The committee will discuss new drug application (NDA) 021-825, proposed trade name FERRIPROX (deferiprone) film-coated tablets and oral solution, manufactured by ApoPharma Inc. The proposed indications (uses) for this product is as 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) 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 which the use of other iron chelating agents has been considered inappropriate.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- Written submissions may be made to the contact person on or before September 21, 2009.
- Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. on October 6. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 11, 2009.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 14, 2009.
- Nicole Vesely
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093)
Rockville, MD 20857
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).