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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Repatha (evolocumab) Injection

Company: Amgen Inc.
Date of Approval: August 27, 2015
Treatment for: High Cholesterol

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

Repatha FDA Approval History

Synjardy (empagliflozin and metformin) Tablets

Company: Eli Lilly and Company and Boehringer Ingelheim
Date of Approval: August 27, 2015
Treatment for: Diabetes Type 2

Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes.

Synjardy FDA Approval History

Keveyis (dichlorphenamide) Tablets

Company: Taro Pharmaceutical Industries Ltd.
Date of Approval: August 7, 2015
Treatment for: Primary Hyperkalemic and Hypokalemic Periodic Paralysis

Keveyis (dichlorphenamide) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic and hypokalemic periodic paralysis.

Keveyis FDA Approval History

Spritam (levetiracetam) Tablets

Company: Aprecia Pharmaceuticals Company
Date of Approval: August 3, 2015
Treatment for: Seizures, Epilepsy

Spritam (levetiracetam) is a 3D printed drug product used as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.

Spritam FDA Approval History

Technivie (ombitasvir, paritaprevir and ritonavir) Tablets

Company: AbbVie Inc.
Date of Approval: July 24, 2015
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.

Technivie FDA Approval History

Odomzo (sonidegib) Capsules

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

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

Odomzo FDA Approval History

Daklinza (daclatasvir) Tablets

Company: Bristol-Myers Squibb Company
Date of Approval: July 24, 2015
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 3 infection.

Daklinza FDA Approval History

Praluent (alirocumab) Injection

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

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

Praluent FDA Approval History

Epiduo Forte (adapalene and benzoyl peroxide) Topical Gel

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

Epiduo Forte FDA Approval History

Envarsus XR (tacrolimus) Extended-Release Tablets

Company: Veloxis Pharmaceuticals A/S
Date of Approval: July 10, 2015
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.

Envarsus XR FDA Approval History

Rexulti (brexpiprazole) Tablets

Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Date of Approval: July 10, 2015
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.

Rexulti FDA Approval History

Entresto (sacubitril and valsartan) Tablets - formerly LCZ696

Company: Novartis Pharmaceuticals Corporation
Date of Approval: July 7, 2015
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.

Entresto FDA Approval History

Orkambi (ivacaftor and lumacaftor) Tablets

Company: Vertex Pharmaceuticals Incorporated
Date of Approval: July 2, 2015
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 12 years and older with two copies of the F508del mutation in their CFTR gene.

Orkambi FDA Approval History

Tuxarin ER (chlorpheniramine and codeine)

Company: Spriaso LLC
Date of Approval: June 22, 2015
Treatment for: Cough, Cold Symptoms

Tuxarin ER (codeine and chlorpheniramine) is a long acting narcotic antitussive and antihistamine combination for the treatment of cough and cold symptoms.

Tuxarin ER FDA Approval History

Kengreal (cangrelor) for Injection

Company: The Medicines Company
Date of Approval: June 22, 2015
Treatment for: Percutaneous Coronary Intervention

Kengreal (cangrelor) is an intravenous P2Y12 platelet inhibitor indicated for use in patients undergoing Percutaneous Coronary Intervention (PCI) to reduce the risk of periprocedural thrombotic events.

Kengreal FDA Approval History

Viberzi (eluxadoline) Tablets

Company: Actavis plc
Date of Approval: May 27, 2015
Treatment for: Irritable Bowel Syndrome

Viberzi (eluxadoline) is a mu-opioid receptor agonist indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Viberzi FDA Approval History

Stiolto Respimat (olodaterol and tiotropium) Inhalation Spray

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: May 21, 2015
Treatment for: Chronic Obstructive Pulmonary Disease

Stiolto Respimat (olodaterol and tiotropium bromide) is a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) fixed-dose combination for the treatment of chronic obstructive pulmonary disease (COPD).

Stiolto Respimat FDA Approval History

Invega Trinza (paliperidone palmitate) Extended-Release Injectable Suspension

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: May 18, 2015
Treatment for: Schizophrenia

Invega Trinza (3-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia.

Invega Trinza FDA Approval History

Raplixa (fibrin sealant [human])

Company: ProFibrix BV
Date of Approval: April 30, 2015
Treatment for: Hemostasis

Raplixa (fibrin sealant [human]) is a spray-dried fibrin sealant used to help control bleeding during surgery.

Raplixa FDA Approval History
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