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IntelGenx Technologies Corp. Message Board

  • edward.drossman edward.drossman Jun 7, 2014 8:58 AM Flag

    based on the fdacalendar below, the earliest the migraine product can get approval would be september

    since it isn't on their schedule below.

    08/18/2014 Regeneron Pharmaceuticals REGN EYLEA (sBLA) FDA decision on EYLEA for the treatment of Diabetic Macular Edema
    08/09/2014 Spectrum Pharmaceuticals Inc SPPI Beleodaq (NDA) FDA decision on Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma
    08/06/2014 The Medicines Co. MDCO Oritavancin (NDA) FDA decision on Oritavancin for the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria
    07/29/2014 Anacor Pharmaceuticals, Inc. ANAC Tavaborole (NDA) FDA decision on Tavaborole for the topical treatment of onychomycosis
    07/27/2014 AcelRx Pharmaceuticals Inc. ACRX Zalviso (NDA) FDA decision on Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting
    07/22/2014 Eagle Pharmaceuticals Inc EGRX Ryanodex (NDA) FDA decision on Ryanodex treatment of malignant hyperthermia
    07/16/2014 Salix Pharmaceuticals Ltd SLXP Ruconest (BLA) FDA decison on Ruconest for the treatment of acute angioedema attacks in patients with hereditary angioedema
    7/15/2014 MannKind Corp. MNKD AFREZZA Inhalation Powder (NDA) FDA decision on AFREZZA Inhalation Powder to improve glycemic control in adult patients suffering from type I or type II diabetes

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