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 patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
• for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.

• 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