Agenda:During the morning session, the committee will discuss new drug application (NDA) 204026, with the established name pomalidomide, application submitted by Celgene Corporation. The proposed indication (use) for this product is in combination with dexamethasone for patients with relapsed and refractory multiple myeloma who have received at least 2 prior regimens of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.
During the afternoon session, the committee will discuss supplemental new drug application (sNDA) 021882/015, with the trade name EXJADE (deferasirox) tablets for oral suspension, application submitted by Novartis Pharmaceutical Corporation. The proposed indication (use) for this product is for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes (beta-thalassemia intermedia, HbE beta-thalassemia, and alpha-thalassemia) aged 10 years and older.
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Procedure: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 October 25, 2012. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those individuals interested in making 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 October 17, 2012. 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 October 18, 2012.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).