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New Drug Approvals Archive - July 2019

See also: New Indications and Dosage Forms for July 2019

July 2019

Xpovio (selinexor) Tablets

Date of Approval: July 3, 2019
Company: Karyopharm Therapeutics Inc.
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

Date of Approval: July 3, 2019
Company: Grifols
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).

Katerzia (amlodipine benzoate) Oral Suspension

Date of Approval: July 8, 2019
Company: Silvergate Pharmaceuticals, Inc.
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.

AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder

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.

Recarbrio (imipenem, cilastatin, and relebactam) for Injection

Date of Approval: July 16, 2019
Company: Merck
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).

Ruxience (rituximab-pvvr) Injection

Date of Approval: July 23, 2019
Company: Pfizer Inc.
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

Date of Approval: July 23, 2019
Company: Samsung Bioepis Co., Ltd.
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).

Baqsimi (glucagon) Nasal Powder

Date of Approval: July 24, 2019
Company: Eli Lilly and Company
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.

Accrufer (ferric maltol) Capsules - formerly Feraccru

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

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

Nubeqa (darolutamide) Tablets

Date of Approval: July 30, 2019
Company: Bayer
Treatment for: Prostate Cancer

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

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