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New Drug Approvals Archive - April 2014

See also: New Indications and Dosage Forms for April 2014

April 2014

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.

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.

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.

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.

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014
Company: Eli Lilly and Company
Treatment for: Gastric Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Hepatocellular Carcinoma

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

  • as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
  • in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
  • in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
  • in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
  • as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

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.

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.

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.

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).

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