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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

Rinvoq (upadacitinib) Extended-Release Tablets

Company: AbbVie Inc.
Date of Approval: August 16, 2019
Treatment for: Rheumatoid Arthritis

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe rheumatoid arthritis.

Inrebic (fedratinib) Capsules

Company: Celgene Corporation
Date of Approval: August 16, 2019
Treatment for: Myelofibrosis

Inrebic (fedratinib) is a highly selective JAK2 inhibitor for the treatment of patients with myelofibrosis.

Rozlytrek (entrectinib) Capsules

Company: Genentech, Inc.
Date of Approval: August 15, 2019
Treatment for: Solid Tumors, Non-Small Cell Lung Cancer

Rozlytrek (entrectinib) is a selective tyrosine kinase inhibitor for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer and neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors.

Wakix (pitolisant) Tablets

Company: Harmony Biosciences, LLC
Date of Approval: August 14, 2019
Treatment for: Narcolepsy

Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

pretomanid Tablets

Company: TB Alliance
Date of Approval: August 14, 2019
Treatment for: Tuberculosis -- Resistant

Pretomanid is a nitroimidazooxazine antimycobacterial indicated for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).

Turalio (pexidartinib) Capsules

Company: Daiichi Sankyo
Date of Approval: August 2, 2019
Treatment for: Tenosynovial Giant Cell Tumor

Turalio (pexidartinib) is a kinase inhibitor indicated for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adults.

Nubeqa (darolutamide) Tablets

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: July 30, 2019
Treatment for: Prostate Cancer

Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

Accrufer (ferric maltol) Capsules - formerly Feraccru

Company: Shield Therapeutics plc
Date of Approval: July 25, 2019
Treatment for: Iron Deficiency

Accrufer (ferric maltol) is a non-salt formulation of ferric iron for the treatment of iron deficiency in adults.

Baqsimi (glucagon) Nasal Powder

Company: Eli Lilly and Company
Date of Approval: July 24, 2019
Treatment for: Hypoglycemia

Baqsimi (glucagon) is a nasally administered antihypoglycemic agent indicated for the treatment of severe hypoglycemia in diabetes patients ages 4 years and older.

Ruxience (rituximab-pvvr) Injection

Company: Pfizer Inc.
Date of Approval: July 23, 2019
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis

Ruxience (rituximab-pvvr) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

Hadlima (adalimumab-bwwd) Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: July 23, 2019
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

Recarbrio (imipenem, cilastatin, and relebactam) for Injection

Company: Merck
Date of Approval: July 16, 2019
Treatment for: Urinary Tract Infection, Intraabdominal Infection

Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections and complicated intra-abdominal infections (cIAI).

AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: July 15, 2019
Treatment for: Asthma

AirDuo Digihaler (fluticasone propionate and salmeterol) is a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) combination therapy for the treatment of asthma in patients aged 12 years and older.

Katerzia (amlodipine benzoate) Oral Suspension

Company: Azurity Pharmaceuticals
Date of Approval: July 8, 2019
Treatment for: Hypertension, Coronary Artery Disease

Katerzia (amlodipine benzoate) is a calcium channel blocker in an oral suspension formulation indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, and coronary artery disease in adults.

Xpovio (selinexor) Tablets

Company: Karyopharm Therapeutics Inc.
Date of Approval: July 3, 2019
Treatment for: Multiple Myeloma

Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with relapsed or refractory multiple myeloma (RRMM).

Xembify (immune globulin subcutaneous, human - klhw) Injection

Company: Grifols
Date of Approval: July 3, 2019
Treatment for: Primary Immunodeficiency Syndrome

Xembify (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI).

Thiola EC (tiopronin) Delayed-Release Tablets

Company: Retrophin, Inc.
Date of Approval: June 28, 2019
Treatment for: Cystinuria

Thiola EC (tiopronin) is a reducing and complexing thiol indicated for the prevention of cystine stone formation in patients with cystinuria.

Zirabev (bevacizumab-bvzr) Injection

Company: Pfizer Inc.
Date of Approval: June 27, 2019
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer

Zirabev (bevacizumab-bvzr) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.

Vyleesi (bremelanotide) Injection

Company: AMAG Pharmaceuticals, Inc.
Date of Approval: June 21, 2019
Treatment for: Hypoactive Sexual Desire Disorder

Vyleesi (bremelanotide) is a melanocortin receptor agonist for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

Myxredlin (insulin human in sodium chloride) Injection

Company: Baxter International Inc.
Date of Approval: June 20, 2019
Treatment for: Diabetes Type 1, Diabetes Type 2

Myxredlin (insulin human in sodium chloride) is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

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