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 cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
• for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes.

• 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 kidney transplant patients.

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

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

Technivie (ombitasvir, paritaprevir and ritonavir) Tablets

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

Marketing Status: Discontinued

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 indicated:

• as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
• to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

• 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

Marketing Status: Discontinued

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