New Drug Approvals Archive - July 2015

Orkambi (ivacaftor and lumacaftor) Tablets

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 6 years and older with two copies of the F508del mutation in their CFTR gene.

FDA Approves Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis

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

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

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

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

Dysport (abobotulinumtoxinA)

New Indication Approved: July 16, 2015

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

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

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

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

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

Kyprolis (carfilzomib)

New Indication Approved: July 24, 2015

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

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

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

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

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