The US FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) Meeting for Thursday, November 6, 2014. During the morning session, the ODAC will discuss new drug application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
During the afternoon session, the ODAC will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease and to reduce the prescribed dos e of erythropoiesis stimulating agent required to maintain desired hemoglobin levels.