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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

Ontruzant (trastuzumab-dttb) for Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: January 18, 2019
Treatment for: Breast Cancer, Gastric Cancer

Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Ultomiris (ravulizumab-cwvz) Injection

Company: Alexion Pharmaceuticals, Inc.
Date of Approval: December 21, 2018
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Elzonris (tagraxofusp-erzs) Injection

Company: Stemline Therapeutics, Inc.
Date of Approval: December 21, 2018
Treatment for: Blastic Plasmacytoid Dendritic Cell Neoplasm

Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

ProAir Digihaler (albuterol sulfate) Inhalation Powder

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: December 21, 2018
Treatment for: Bronchospasm Prophylaxis, Asthma, Chronic Obstructive Pulmonary Disease

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Suspension for Intramuscular Injection

Company: Merck and Sanofi
Date of Approval: December 21, 2018
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prophylaxis, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

Inbrija (levodopa) Inhalation Powder

Company: Acorda Therapeutics, Inc.
Date of Approval: December 21, 2018
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

Asparlas (calaspargase pegol-mknl) Injection

Company: Servier Pharmaceuticals LLC
Date of Approval: December 20, 2018
Treatment for: Acute Lymphoblastic Leukemia

Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia.

Motegrity (prucalopride) Tablets

Company: Shire plc
Date of Approval: December 14, 2018
Treatment for: Chronic Idiopathic Constipation

Motegrity (prucalopride) is a selective serotonin type 4 (5‑HT4) receptor agonist for the treatment of chronic idiopathic constipation (CIC) in adults.

Herzuma (trastuzumab-pkrb) for Injection

Company: Celltrion, Inc. and Teva Pharmaceutical Industries Ltd.
Date of Approval: December 14, 2018
Treatment for: Breast Cancer

Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer.

Tolsura (itraconazole) Capsules

Company: Mayne Pharma US
Date of Approval: December 11, 2018
Treatment for: Blastomycosis; Histoplasmosis; Aspergillosis

Tolsura (itraconazole) is an azole antifungal indicated for the treatment of certain fungal infections including blastomycosis, histoplasmosis and aspergillosis.

Dextenza (dexamethasone) Ophthalmic Insert

Company: Ocular Therapeutix, Inc.
Date of Approval: November 30, 2018
Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain.

Xospata (gilteritinib) Tablets

Company: Astellas Pharma US, Inc.
Date of Approval: November 28, 2018
Treatment for: Acute Myeloid Leukemia

Xospata (gilteritinib) is a FLT3/AXL kinase inhibitor indicated for the treatment of patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Firdapse (amifampridine phosphate) Tablets

Company: Catalyst Pharmaceuticals, Inc.
Date of Approval: November 28, 2018
Treatment for: Lambert Eaton Myasthenic Syndrome

Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS).

Truxima (rituximab-abbs) Injection

Company: Celltrion, Inc.
Date of Approval: November 28, 2018
Treatment for: non-Hodgkin's Lymphoma

Truxima (rituximab-abbs) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma.

Vitrakvi (larotrectinib) Capsules and Oral Solution

Company: Loxo Oncology, Inc.
Date of Approval: November 26, 2018
Treatment for: TRK Fusion Cancers

Vitrakvi (larotrectinib) is an oral selective tropomyosin receptor kinase (TRK) inhibitor for the treatment solid tumors harboring NTRK-fusion proteins.

Daurismo (glasdegib) Tablets

Company: Pfizer Inc.
Date of Approval: November 21, 2018
Treatment for: Acute Myeloid Leukemia

Daurismo (glasdegib) is a hedgehog pathway inhibitor indicated for the combination treatment of adult patients ≥75 years with newly-diagnosed acute myeloid leukemia (AML).

Gamifant (emapalumab-lzsg) Injection

Company: Novimmune SA
Date of Approval: November 20, 2018
Treatment for: Hemophagocytic Lymphohistiocytosis

Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH).

Aemcolo (rifamycin) Delayed-Release Tablets

Company: Cosmo Technologies, Ltd.
Date of Approval: November 16, 2018
Treatment for: Traveler's Diarrhea

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.

Yupelri (revefenacin) Inhalation Solution

Company: Theravance, Inc.
Date of Approval: November 9, 2018
Treatment for: Chronic Obstructive Pulmonary Disease

Yupelri (revefenacin) is a long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).

Primatene Mist (epinephrine) Inhalation Aerosol

Company: Amphastar Pharmaceuticals, Inc.
Date of Approval: November 8, 2018
Treatment for: Asthma

Primatene Mist (epinephrine) is an over-the-counter (OTC) bronchodilator used for the temporary relief of the symptoms of mild asthma. The new formulation of Primatene Mist approved November 2018 is a CFC-free metered dose inhaler (MDI) containing hydrofluoroalkane (HFA) propellants.

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