New Drug Approvals Archive - July 2015

Orkambi (ivacaftor and lumacaftor) Tablets and Oral Granules

Date of Approval: July 2, 2015
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Orkambi (ivacaftor and lumacaftor) is a CFTR potentiator and CFTR corrector combination for the treatment of the underlying cause of cystic fibrosis in patients 2 years and older with two copies of the F508del mutation in their CFTR gene.

• FDA Approves Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis
• Orkambi (ivacaftor and lumacaftor) FDA Approval History

Entresto (sacubitril and valsartan) Tablets - formerly LCZ696

Date of Approval: July 7, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Heart Failure

Entresto (sacubitril and valsartan) is a neprilysin inhibitor and angiotensin II receptor blocker combination indicated to reduce the risk of death and hospitalization in patients with chronic heart failure.

• FDA Approves Entresto (sacubitril/valsartan) for Heart Failure
• Entresto (sacubitril and valsartan) FDA Approval History

Rexulti (brexpiprazole) Tablets

Date of Approval: July 10, 2015
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia; Major Depressive Disorder

Rexulti (brexpiprazole) is a serotonin-dopamine activity modulator (SDAM) for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder.

• FDA Approves Rexulti (brexpiprazole) for Schizophrenia and Adjunctive Treatment for Major Depressive Disorder
• Rexulti (brexpiprazole) FDA Approval History

Envarsus XR (tacrolimus) Extended-Release Tablets

Date of Approval: July 10, 2015
Company: Veloxis Pharmaceuticals A/S
Treatment for: Organ Transplant -- Rejection Prophylaxis

Envarsus XR (tacrolimus) is a once-daily extended-release immunosuppressant for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants.

• FDA Approves Envarsus XR (tacrolimus) for Prevention of Organ Rejection in Kidney Transplant Patients
• Envarsus XR (tacrolimus) FDA Approval History

Iressa (gefitinib)

New Indication Approved: July 13, 2015

• FDA Approves Iressa (gefitinib) for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer

Epiduo Forte (adapalene and benzoyl peroxide) Topical Gel

Date of Approval: July 15, 2015
Company: Galderma Laboratories, L.P.
Treatment for: Acne

Epiduo Forte (adapalene and benzoyl peroxide) gel is a topical retinoid and benzoyl peroxide combination indicated for the topical treatment of acne vulgaris.

• Galderma Receives FDA Approval for Epiduo Forte (adapalene and benzoyl peroxide) for Acne
• Epiduo Forte (adapalene and benzoyl peroxide) FDA Approval History

Dysport (abobotulinumtoxinA)

New Indication Approved: July 16, 2015

• Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity
• Dysport (abobotulinumtoxinA) FDA Approval History

Technivie (ombitasvir, paritaprevir and ritonavir) Tablets

Date of Approval: July 24, 2015
Company: AbbVie Inc.
Treatment for: Chronic Hepatitis C

Technivie (ombitasvir, paritaprevir and ritonavir) is an NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for use in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection.

• FDA Approves Technivie (ombitasvir, paritaprevir and ritonavir) for Chronic Hepatitis C Genotype 4 Infections
• Technivie (ombitasvir, paritaprevir and ritonavir) FDA Approval History

Odomzo (sonidegib) Capsules

Date of Approval: July 24, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Basal Cell Carcinoma

Odomzo (sonidegib) is a hedgehog pathway inhibitor indicated for the treatment of locally advanced basal cell carcinoma (BCC).

• FDA Approves Odomzo (sonidegib) for Locally Advanced Basal Cell Carcinoma
• Odomzo (sonidegib) FDA Approval History

Praluent (alirocumab) Injection

Date of Approval: July 24, 2015
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody for the treatment of patients with heterozygous familial hypercholesterolemia or atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

• FDA Approves Praluent (alirocumab) to Treat Certain Patients with High Cholesterol
• Praluent (alirocumab) FDA Approval History

Daklinza (daclatasvir) Tablets

Date of Approval: July 24, 2015
Company: Bristol-Myers Squibb Company
Treatment for: Chronic Hepatitis C

Daklinza (daclatasvir) is an NS5A inhibitor indicated for use in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.

• FDA Approves Daklinza (daclatasvir) for Chronic Hepatitis C Genotype 3 Infections
• Daklinza (daclatasvir) FDA Approval History

Kyprolis (carfilzomib)

New Indication Approved: July 24, 2015

• FDA Approves Kyprolis (carfilzomib) for Combination Treatment of Patients with Relapsed Multiple Myeloma
• Kyprolis (carfilzomib) FDA Approval History

Finacea (azelaic acid)

New Dosage Form Approved: July 29, 2015

• FDA Approves Finacea (azelaic acid) Foam for Rosacea

Daklinza (daclatasvir)

New Indication Approved: February 5, 2016

• FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C
• Daklinza (daclatasvir) FDA Approval History

Rexulti (brexpiprazole)

Labeling Revision Approved: September 23, 2016
Treatment for: Schizophrenia; Major Depressive Disorder

• U.S. FDA Approves Labeling Update of Rexulti (brexpiprazole) for Maintenance Treatment of Schizophrenia
• Rexulti (brexpiprazole) FDA Approval History

Orkambi (ivacaftor and lumacaftor)

Patient Population Altered: September 28, 2016

• FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation
• Orkambi (ivacaftor and lumacaftor) FDA Approval History

Praluent (alirocumab)

New Dosage Regimen: April 24, 2017
Treatment for: High Cholesterol

• Sanofi and Regeneron Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent (alirocumab) Injection
• Praluent (alirocumab) FDA Approval History

Orkambi (ivacaftor and lumacaftor)

New Dosage Form Approved: August 7, 2018

• FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
• Orkambi (ivacaftor and lumacaftor) FDA Approval History