FDA Calendar

DateCompany NameTickerDrugEventOutcomeDetails
07/22/2014Eagle Pharmaceuticals Inc EGRX Ryanodex (NDA)FDA decision on Ryanodex treatment of malignant hyperthermia
07/16/2014Salix Pharmaceuticals Ltd SLXP Ruconest (BLA)FDA decison on Ruconest for the treatment of acute angioedema attacks in patients with hereditary angioedema
07/15/2014MannKind 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
06/25/2014AstraZeneca PLC AZN.L, AZN Olaparib capsules (NDA)FDA panel to review Olaparib as monotherapy for relapsed ovarian cancer
06/20/2014Cubist Pharmaceuticals Inc CBST Tedizolid phosphate (NDA) FDA decision on Tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections
-Drug Status

06/16/2014Navidea Biopharmaceuticals, Inc. NEOP, NAVB Lymphoseek Injection ?(sNDA)FDA decision on Lymphoseek Injection for sentinel lymph node detection in patients with head and neck cancer
06/10/2014Orexigen Therapeutics Inc. OREX Contrave (NDA resubmission)FDA decision on Contrave for weight loss and maintenance of weight loss.
06/07/2014Keryx Biopharmaceuticals Inc KERX Zerenex (NDA)FDA decision on Zerenex for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis
05/28/2014Trimel Pharmaceuticals Corp. TRL.TO CompleoTRT (NDA)FDA decision on CompleoTRT, a bioadhesive intranasal gel formulation of testosterone
05/25/2014QRX PHARMA QRXPY.PK, QRX.AX MOXDUO (Resubmitted NDA)FDA decision on MOXDUO for the treatment of moderate to severe acute pain
04/30/2014The Medicines Co. MDCO Cangrelor (NDA)FDA decision on Cangrelor for use in patients undergoing percutaneous coronary intervention or cardiac stent procedures or those that require bridging from oral antiplatelet therapy to surgery
-Drug Status

04/28/2014Flamel Technologies SA FLML Undisclosed Éclat product (NDA)FDA decision on the undisclosed Éclat product
04/25/2014POZEN Inc. POZN PA32540/PA8140 (NDA) FDA decision on PA32540/PA8140 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers
04/22/2014QRX PHARMA QRXPY.PK, QRX.AX Moxduo (resubmitted NDA)FDA panel to review Moxduo for the treatment of moderate to severe acute pain, FDA panel recommends against approval of Moxduo for the treatment of moderate to severe acute pain
04/19/2014GlaxoSmithKline PLC GSK.L, GSK Arzerra (sBLA)FDA decision on Arzerra for 1st line treatment of chronic lymphocytic leukemia FDA approved Arzerra for 1st line treatment of chronic lymphocytic leukemia on Apr.17, 2014
-Approved in Other Countries

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