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Panel to Discuss NDAs for Myeloma, Iron Loss

10/09/2014

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 11/6, from 8 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. During the morning session, the committee will discuss a Novartis Pharmaceuticals NDA for panobinostat capsules for use in combination with bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy.

During the afternoon session, the committee will discuss a Rockwell Medical NDA for ferric pyrophosphate solution, for administration via hemodialysis dialysate for treating iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease and to reduce the prescribed dose of erythropoiesis stimulating agent required to maintain desired hemoglobin levels. Contact Caleb Briggs, (301) 796-9001. To view this notice, click here.

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