New Drug Approvals Archive - September 2014
See also: New Indications and Dosage Forms for September 2014
September 2014
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
Company: Merck & Co., Inc.
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Head and Neck Cancer, Hodgkin's Lymphoma, Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Esophageal Carcinoma, Endometrial Cancer, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Breast Cancer
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.
Auryxia (ferric citrate) Tablets
Date of Approval: September 5, 2014
Company: Keryx Biopharmaceuticals, Inc.
Treatment for: Hyperphosphatemia of Renal Failure, Anemia Associated with Chronic Renal Failure
Auryxia (ferric citrate) is a phosphate binder indicated for the control of serum phosphorus levels in dialysis patients; and an iron replacement product for the treatment of iron deficiency anemia in adult patients with chronic kidney disease who are not on dialysis.
Contrave (bupropion and naltrexone) Tablets
Date of Approval: September 10, 2014
Company: Orexigen Therapeutics, Inc.
Treatment for: Obesity
Contrave (bupropion/naltrexone) is an aminoketone antidepressant and opioid antagonist combination indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.
Movantik (naloxegol) Tablets
Date of Approval: September 16, 2014
Company: AstraZeneca Pharmaceuticals LP
Treatment for: Opioid-Induced Constipation
Movantik (naloxegol) is a peripherally-acting mu-opioid receptor antagonist indicated for the treatment of opioid-induced constipation.
Trulicity (dulaglutide) Injection
Date of Approval: September 18, 2014
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction
Trulicity (dulaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
Vitekta (elvitegravir) Tablets
Date of Approval: September 24, 2014
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Marketing Status: Discontinued
Vitekta (elvitegravir) is an integrase inhibitor for the combination treatment of HIV-1 infection in treatment-experienced adults.
Tybost (cobicistat) Tablets
Date of Approval: September 24, 2014
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Tybost (cobicistat) is a potent inhibitor of cytochrome P450 3A (CYP3A) which acts as a pharmacoenhancing or "boosting" agent for antiviral drugs used in the treatment of HIV infection.
Iluvien (fluocinolone acetonide) Intravitreal Implant
Date of Approval: September 26, 2014
Company: pSivida Corp.
Treatment for: Diabetic Macular Edema
Iluvien (fluocinolone acetonide) is an intravitreal implant for the treatment of diabetic macular edema.
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