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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 Disease, Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Small Cell Lung Cancer, Esophageal Carcinoma, Endometrial Carcinoma

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

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

Trulicity (dulaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.

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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