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 Disease, Urothelial Carcinoma, Gastric Cancer, Cervical 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, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

• 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

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

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

Otezla (apremilast)

New Indication Approved: September 23, 2014

• FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis
• Otezla (apremilast) FDA Approval History

Minivelle (estradiol)

New Indication Approved: September 23, 2014

• Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle
• Minivelle (estradiol) FDA Approval History

Spiriva Respimat (tiotropium bromide)

New Formulation Approved: September 25, 2014

• FDA Approves Spiriva Respimat (tiotropium) for the Maintenance Treatment of COPD
• Spiriva Respimat (tiotropium bromide) FDA Approval History

Humira (adalimumab)

Patient Population Altered: September 23, 2014

• FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease

Vitekta (elvitegravir) Tablets

Date of Approval: September 24, 2014
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

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

Abilify Maintena (aripiprazole)

New Dosage Form Approved: September 29, 2014

• FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia
• Abilify Maintena (aripiprazole) FDA Approval History

Ozurdex (dexamethasone)

New Indication Approved: September 26, 2014

• FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema
• Ozurdex (dexamethasone) FDA Approval History

Auryxia (ferric citrate)

Labeling Revision Approved: November 17, 2014

• Keryx Biopharmaceuticals Announces Trade Name Auryxia for Ferric Citrate
• Auryxia (ferric citrate) FDA Approval History

Spiriva Respimat (tiotropium bromide)

New Indication Approved: September 15, 2015

• FDA Approves Spiriva Respimat (tiotropium) for Maintenance Treatment of Asthma in Adults and Adolescents
• Spiriva Respimat (tiotropium bromide) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: October 2, 2015

• FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: December 18, 2015

• FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: August 5, 2016

• FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: October 24, 2016

• FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer
• Keytruda (pembrolizumab) FDA Approval History

Spiriva Respimat (tiotropium bromide)

Patient Population Altered: February 15, 2017

• FDA Expands Approval of Spiriva Respimat (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children
• Spiriva Respimat (tiotropium bromide) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: March 14, 2017

• FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: May 10, 2017

• FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: May 18, 2017

• FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: May 23, 2017

• FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: September 22, 2017

• FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
• Keytruda (pembrolizumab) FDA Approval History

Auryxia (ferric citrate)

New Indication Approved: November 7, 2017

• FDA Approves Auryxia (ferric citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis
• Auryxia (ferric citrate) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: June 12, 2018

• FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: June 13, 2018

• FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
• Keytruda (pembrolizumab) FDA Approval History