New Drug Approvals Archive - 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.

• FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma
• Keytruda (pembrolizumab) FDA Approval History

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.

• Keryx Biopharmaceuticals Receives FDA Approval of Ferric Citrate for Dialysis Patients With Hyperphosphatemia
• Auryxia (ferric citrate) FDA Approval History

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.

• FDA Approves Contrave (bupropion/naltrexone) for Weight Management
• Contrave (bupropion and naltrexone) FDA Approval History

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.

• FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation
• Movantik (naloxegol) FDA Approval History

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.

• FDA Approves Trulicity (dulaglutide) for Type 2 Diabetes
• Trulicity (dulaglutide) FDA Approval History

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.

• FDA Approves Vitekta (elvitegravir) for HIV-1 Infection
• Vitekta (elvitegravir) FDA Approval History

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.

• FDA Approves Tybost (cobicistat) for use in the treatment of HIV-1 Infection
• Tybost (cobicistat) FDA Approval History

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.

• FDA Approves Iluvien for Diabetic Macular Edema
• Iluvien (fluocinolone acetonide) FDA Approval History