FDA Calendar 10/21/2013 AMAG

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FDA Calendar

10/21/2013 AMAG Pharmaceuticals Inc. AVM , AMAG Feraheme (sNDA) FDA decision to expand the indication beyond treatment of iron deficiency anemia in adult patients with chronic kidney disease to adult patients with IDA who cannot take oral iron
10/17/2013 pSivida Limited PSDV ILUVIEN (NDA resubmission) FDA decision on ILUVIEN for treatment of chronic diabetic macular edema
10/16/2013 Amarin Corp Plc AMRN Vascepa (sNDA) FDA panel decision on Vascepa as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and < 500 mg/dL) with mixed dyslipidemia
10/14/2013 Antares Pharma Inc. ATRS , AIS OTREXUP (NDA) FDA decision on OTREXUP for self-administration of methotrexate to enhance the treatment of rheumatoid arthritis (RA
-News
10/03/2013 Ligand Pharmaceuticals Inc LGND Bazedoxifene/Conjugated estrogens or BZA/CE (NDA) FDA decision on BZA/CE for symptoms associated with menopause and prevention of osteoporosis
09/21/2013 Celgene Corporation CELG ABRAXANE (sBLA) FDA decision on ABRAXANE for the first–line treatment of patients with advanced pancreatic cance
09/14/2013 Seattle Genetics Inc. SGEN ADCETRIS (sBLA) FDA decision on ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma
09/13/2013 Delcath Systems Inc. DCTH Melblez Kit (NDA) FDA decision on Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liver
09/03/2013 GlaxoSmithKline PLC GSK.L, GSK Trametinib (NDA) FDA decision on Trametinib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations
09/01/2013 Otsuka Holdings Co., Ltd. OTSKF.PK Tolvaptan (NDA) FDA decision on Tolvaptan for the treatment of autosomal dominant polycystic kidney disease
-News
08/26/2013 QRX PHARMA QRXPY.PK, QRX.AX MOXDUO (Resubmitted NDA) FDA decision on MOXDUO for the treatment of acute pain
08/06/2013 Bayer AG BAYZF.PK, BAYRY.PK, BYR.L Adempas (NDA) FDA panel to review Adempas for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
07/28/2013 AVEO Pharmaceuticals, Inc. AVEO TIVOPATH aka Tivozanib (NDA) FDA decision on TIVOPATH for advanced renal cell carcinoma FDA issued Complete Response Letter for Tivozanib on June 10, 2013
07/23/2013 AbbVie ABBV HUMIRA (sBLA) FDA panel to review HUMIRA injection, for addnl indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis FDA panel voted 12 to 1 against recommending HUMIRA for treating adult patients with active non-radiographic axial spondyloarthritis
07/18/2013 Merck & Co Inc. MRK Sugammadex sodium injection (NDA) FDA panel to review Sugammadex sodium for the proposed indications of routine reversal of moderate and deep neuromuscular blockade FDA panel meeting cancelled as the agency has sought additional time to assess the results of recently completed inspection of a clinical trial site
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