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New Drug Approvals Archive - April 2014

April 2014

April 3	Evzio (naloxone hydrochloride) Date of Approval: April 3, 2014 Company: Kaleo Inc. Treatment for: Opioid Overdose Evzio (naloxone hydrochloride) is an opioid antagonist hand-held auto-injector indicated for the emergency treatment of known or suspected opioid overdose. FDA Approves Evzio (naloxone) Hand-Held Auto-Injector to Reverse Opioid Overdose Evzio (naloxone hydrochloride) FDA Approval History
April 7	Kalbitor (ecallantide) New Dosage Form Approved: April 3, 2014 FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older Kalbitor (ecallantide) FDA Approval History
April 7	Pradaxa (dabigatran etexilate) New Indication Approved: April 7, 2014 FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism Pradaxa (dabigatran etexilate) FDA Approval History
April 15	Tanzeum (albiglutide) Injection Date of Approval: April 15, 2014 Company: GlaxoSmithKline (GSK) plc Treatment for: Diabetes Type 2 Tanzeum (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes. FDA Approves Tanzeum (albiglutide) to Treat Type 2 Diabetes Tanzeum (albiglutide) FDA Approval History
April 17	Ragwitek (ragweed pollen allergen extract) Date of Approval: April 17, 2014 Company: Merck & Co., Inc. Treatment for: Ragweed Allergies Ragwitek (short ragweed pollen allergen extract) is a sublingual immunotherapy for the treatment of ragweed allergies. FDA Approves Ragwitek for Short Ragweed Pollen Allergies Ragwitek (ragweed pollen allergen extract) FDA Approval History
April 16	Xulane (ethinyl estradiol and norelgestromin) Transdermal System Date of Approval: April 16, 2014 Company: Mylan Inc. Treatment for: Contraception Xulane (ethinyl estradiol and norelgestromin transermal system) is a generic version of Ortho Evra, a birth control patch used to prevent pregnancy. Mylan Launches Xulane - First Generic Ortho Evra Patch Xulane (ethinyl estradiol and norelgestromin) FDA Approval History
April 21	Cyramza (ramucirumab) Injection Date of Approval: April 21, 2014 Company: Eli Lilly and Company Treatment for: Stomach Cancer Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer and non-small cell lung cancer. FDA Approves Cyramza for Stomach Cancer Cyramza (ramucirumab) FDA Approval History
April 22	Sylvant (siltuximab) for Injection Date of Approval: April 22, 2014 Company: Janssen Research & Development, LLC Treatment for: Multicentric Castleman's Disease Sylvant (siltuximab) is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman’s disease. FDA Approves Sylvant for Multicentric Castleman’s Disease Sylvant (siltuximab) FDA Approval History
April 29	Zykadia (ceritinib) Capsules Date of Approval: April 29, 2014 Company: Novartis Pharmaceuticals Corporation Treatment for: Non-Small Cell Lung Cancer Zykadia (ceritinib) is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer. FDA Approves Zykadia (ceritinib) for Metastatic Non-Small Cell Lung Cancer Zykadia (ceritinib) FDA Approval History
April 28	Purixan (mercaptopurine) Oral Suspension Date of Approval: April 28, 2014 Company: Nova Laboratories, Ltd. Treatment for: Acute Lymphoblastic Leukemia Purixan (mercaptopurine) is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia. FDA Approves Purixan (mercaptopurine) Oral Suspension Purixan (mercaptopurine) FDA Approval History
April 30	Incruse Ellipta (umeclidinium) Inhalation Powder Date of Approval: April 30, 2014 Company: GlaxoSmithKline Treatment for: Chronic Obstructive Pulmonary Disease -- Maintenance Incruse Ellipta (umeclidinium) is an anticholinergic bronchodilator indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). FDA Approves Incruse Ellipta (umeclidinium) for the Treatment of COPD Incruse Ellipta (umeclidinium) FDA Approval History
November 5	Cyramza (ramucirumab) Labeling Revision Approved: November 5, 2014 FDA Approves Cyramza (ramucirumab) in Combination with Paclitaxel for Advanced Gastric Cancer after Prior Chemotherapy Cyramza (ramucirumab) FDA Approval History
December 12	Cyramza (ramucirumab) New Indication Approved: December 12, 2014 FDA Expands Approved use of Cyramza to Treat Aggressive Non-Small Cell Lung Cancer Cyramza (ramucirumab) FDA Approval History
April 24	Cyramza (ramucirumab) New Indication Approved: April 24, 2015 FDA Approves Cyramza (Ramucirumab) for Use with FOLFIRI in Second-Line Treatment of Metastatic Colorectal Cancer Cyramza (ramucirumab) FDA Approval History
May 26	Zykadia (ceritinib) New Indication Approved: May 26, 2017 Novartis Receives FDA Approval for Expanded Use of Zykadia in First-Line ALK-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) Zykadia (ceritinib) FDA Approval History

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