New Drug Approvals Archive for 2019
See also: New Indications and Dosage Forms for 2019
Ontruzant (trastuzumab-dttb) for Injection
Date of Approval: January 18, 2019
Company: Organon Pharmaceuticals
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.
Tosymra (sumatriptan) Nasal Spray
Date of Approval: January 25, 2019
Company: Dr. Reddy's Laboratories, Inc.
Treatment for: Migraine
Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.
Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder
Date of Approval: January 30, 2019
Company: Mylan N.V.
Treatment for: Asthma, COPD
Wixela Inhub is the first approved generic version of Advair Diskus.
Jeuveau (prabotulinumtoxinA-xvfs) Injection
Date of Approval: February 1, 2019
Company: Evolus, Inc.
Treatment for: Glabellar Lines
Jeuveau (prabotulinumtoxinA) is a proprietary 900 kDa purified botulinum toxin type A formulation for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines.
Cablivi (caplacizumab-yhdp) Injection
Date of Approval: February 6, 2019
Company: Ablynx NV
Treatment for: Acquired Thrombotic Thrombocytopenic Purpura
Cablivi (caplacizumab-yhdp) is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Egaten (triclabendazole) Tablets
Date of Approval: February 13, 2019
Company: Novartis
Treatment for: Fascioliasis
Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.
Esperoct (antihemophilic factor (recombinant) glycopegylated-exei) Injection
Date of Approval: February 19, 2019
Company: Novo Nordisk
Treatment for: Hemophilia A
Esperoct (antihemophilic factor [recombinant] glycopegylated-exei) is an extended half-life factor VIII molecule that may be used to treat or prevent bleeding episodes in adults and children with hemophilia A.
Gloperba (colchicine) Oral Solution
Date of Approval: January 30, 2019
Company: Romeg Therapeutics, LLC
Treatment for: Gout
Gloperba (colchicine) is an oral solution formulation of the approved drug colchicine indicated for prophylaxis of gout flares in adults.
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for Subcutaneous Injection
Date of Approval: February 28, 2019
Company: Genentech, Inc.
Treatment for: Breast Cancer
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is a combination of the approved HER2/neu receptor antagonist trastuzumab (Herceptin) and recombinant human hyaluronidase PH20 (an enzyme that helps to deliver trastuzumab under the skin) indicated for the treatment of HER2-overexpressing breast cancer.
Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules
Date of Approval: February 27, 2019
Company: Purdue Pharma L.P.
Treatment for: ADHD
Adhansia XR (methylphenidate hydrochloride) is an extended-release capsule formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older.
Spravato (esketamine) Nasal Spray
Date of Approval: March 5, 2019
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Depression, Major Depressive Disorder with Acute Suicidal Ideation
Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
Trazimera (trastuzumab-qyyp) for Injection
Date of Approval: March 11, 2019
Company: Pfizer Inc.
Treatment for: Breast Cancer, Gastric Cancer
Trazimera (trastuzumab-qyyp) 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.
Rocklatan (netarsudil and latanoprost) Ophthalmic Solution
Date of Approval: March 12, 2019
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension
Rocklatan (netarsudil and latanoprost ophthalmic solution) is a fixed dose combination of the Rho kinase inhibitor netarsudil (Rhopressa) and the prostaglandin F2α analogue latanoprost (Xalatan), indicated to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Zulresso (brexanolone) Injection
Date of Approval: March 19, 2019
Company: Sage Therapeutics
Treatment for: Postpartum Depression
Zulresso (brexanolone) is a gamma-aminobutyric acid A (GABAA) receptor positive allosteric modulator indicated for the treatment of postpartum depression (PPD).
Sunosi (solriamfetol) Tablets
Date of Approval: March 20, 2019
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome
Sunosi (solriamfetol) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
Mayzent (siponimod) Tablets
Date of Approval: March 26, 2019
Company: Novartis
Treatment for: Multiple Sclerosis
Mayzent (siponimod) is a sphingosine-1-phosphate receptor modulator for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Jatenzo (testosterone undecanoate) Capsules
Date of Approval: March 27, 2019
Company: Clarus Therapeutics, Inc.
Treatment for: Hypogonadism, Male
Jatenzo (testosterone undecanoate) is an oral testosterone replacement therapy for the treatment of low testosterone in hypogonadal men.
Mavenclad (cladribine) Tablets
Date of Approval: March 29, 2019
Company: EMD Serono, Inc.
Treatment for: Multiple Sclerosis
Mavenclad (cladribine) is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Duaklir Pressair (aclidinium bromide and formoterol fumarate) Inhalation Powder
Date of Approval: March 29, 2019
Company: Circassia Pharmaceuticals plc
Treatment for: COPD
Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) fixed dose combination maintenance bronchodilator for the treatment of COPD.
Asceniv (immune globulin intravenous, human – slra) Injection
Date of Approval: April 1, 2019
Company: ADMA Biologics, Inc.
Treatment for: Primary Immunodeficiency Syndrome
Asceniv (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI).
Avaclyr (acyclovir) Ophthalmic Ointment
Date of Approval: March 29, 2019
Company: Fera Pharmaceuticals
Treatment for: Herpes Simplex Dendritic Keratitis
Avaclyr (acyclovir ophthalmic ointment) is a herpes simplex virus nucleoside analog DNA polymerase inhibitor indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.
Dovato (dolutegravir and lamivudine) Tablets
Date of Approval: April 8, 2019
Company: ViiV Healthcare
Treatment for: HIV Infection
Dovato (dolutegravir and lamivudine) is an integrase strand transfer inhibitor and nucleoside analogue reverse transcriptase inhibitor combination used for the treatment of HIV-1 infection.
Evenity (romosozumab-aqqg) Injection
Date of Approval: April 9, 2019
Company: Amgen Inc.
Treatment for: Osteoporosis
Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Balversa (erdafitinib) Tablets
Date of Approval: April 12, 2019
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma
Balversa (erdafitinib) is a pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
Plenity (cellulose and citric acid) Capsules
Date of Approval: April 12, 2019
Company: Gelesis
Treatment for: Weight Loss (Obesity/Overweight)
Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in adults who are overweight or obese. It works by inducing a feeling of fullness so that patients eat less and lose weight.
Skyrizi (risankizumab-rzaa) Injection
Date of Approval: April 23, 2019
Company: AbbVie Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Duobrii (halobetasol propionate and tazarotene) Lotion
Date of Approval: April 25, 2019
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis
Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination indicated for the topical treatment of plaque psoriasis.
Eticovo (etanercept-ykro) Injection
Date of Approval: April 25, 2019
Company: Samsung Bioepis Co., Ltd.
Eticovo (etanercept-ykro) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
Dengvaxia (dengue tetravalent vaccine, live) Injection
Date of Approval: May 1, 2019
Company: Sanofi Pasteur, Inc.
Treatment for: Prevention of Dengue Disease
Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.
Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) Extended-Release Tablets
Date of Approval: May 2, 2019
Company: AstraZeneca
Treatment for: Type 2 Diabetes
Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, biguanide and dipeptidyl peptidase-4 (DPP-4) inhibitor combination indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Vyndaqel (tafamidis meglumine) Capsules
Date of Approval: May 3, 2019
Company: Pfizer Inc.
Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis
Vyndaqel (tafamidis meglumine) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis.
Ruzurgi (amifampridine) Tablets
Date of Approval: May 6, 2019
Company: Jacobus Pharmaceutical Company, Inc.
Treatment for: Lambert-Eaton Myasthenic Syndrome
Ruzurgi (amifampridine) is a potassium-channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age.
Nayzilam (midazolam) Nasal Spray
Date of Approval: May 17, 2019
Company: UCB
Treatment for: Seizure Clusters
Nayzilam (midazolam) is a nasally administered benzodiazepine indicated for the acute treatment of seizure clusters.
Piqray (alpelisib) Tablets
Date of Approval: May 24, 2019
Company: Novartis
Treatment for: Breast Cancer
Piqray (alpelisib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR positive, HER2-negative, PIK3CA-mutated breast cancer.
Zolgensma (onasemnogene abeparvovec-xioi) Suspension for Intravenous Infusion
Date of Approval: May 24, 2019
Company: Novartis
Treatment for: Spinal Muscular Atrophy
Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA).
Slynd (drospirenone) Tablets
Date of Approval: May 23, 2019
Company: Exeltis
Treatment for: Birth Control
Slynd (drospirenone) is a progestin oral contraceptive for birth control.
Polivy (polatuzumab vedotin-piiq) Injection
Date of Approval: June 10, 2019
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma
Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody and microtubule inhibitor conjugate used for the treatment of diffuse large B-cell lymphoma.
Kanjinti (trastuzumab-anns) Injection
Date of Approval: June 13, 2019
Company: Amgen Inc.
Treatment for: Breast Cancer, Gastric Cancer
Kanjinti (trastuzumab-anns) 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.
Vyleesi (bremelanotide) Injection
Date of Approval: June 21, 2019
Company: Cosette Pharmaceuticals, Inc.
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.
Zirabev (bevacizumab-bvzr) Injection
Date of Approval: June 27, 2019
Company: Pfizer Inc.
Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal 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; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Thiola EC (tiopronin) Delayed-Release Tablets
Date of Approval: June 28, 2019
Company: Retrophin, Inc.
Treatment for: Cystinuria
Thiola EC (tiopronin) is a reducing and complexing thiol indicated for the prevention of cystine stone formation in patients with cystinuria.
Xpovio (selinexor) Tablets
Date of Approval: July 3, 2019
Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma; Diffuse Large B-cell Lymphoma
Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with multiple myeloma (RRMM) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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) in patients 2 years of age and older.
Katerzia (amlodipine benzoate) Oral Suspension
Date of Approval: July 8, 2019
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, 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, Nosocomial Pneumonia
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 (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
Myxredlin (insulin human in sodium chloride) Injection
Date of Approval: June 20, 2019
Company: Baxter International Inc.
Treatment for: Diabetes, Type 1, Type 2 Diabetes
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.
Ruxience (rituximab-pvvr) Injection
Date of Approval: July 23, 2019
Company: Pfizer Inc.
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, 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: Organon Pharmaceuticals
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker biosimilar/interchangeable to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
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) used in the treatment of prostate cancer.
Turalio (pexidartinib) Capsules
Date of Approval: August 2, 2019
Company: Daiichi Sankyo Company, Limited
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.
(pretomanid) Tablets
Date of Approval: August 14, 2019
Company: TB Alliance
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).
Rozlytrek (entrectinib) Capsules and Oral Pellets
Date of Approval: August 15, 2019
Company: Genentech, Inc.
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
Date of Approval: August 14, 2019
Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy
Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of narcolepsy.
Inrebic (fedratinib) Capsules
Date of Approval: August 16, 2019
Company: Celgene Corporation
Treatment for: Myelofibrosis
Inrebic (fedratinib) is a highly selective JAK2 inhibitor for the treatment of patients with myelofibrosis.
Rinvoq (upadacitinib) Extended-Release Tablets
Date of Approval: August 16, 2019
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ulcerative Colitis, Crohn's Disease, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis, Polyarticular Juvenile Idiopathic Arthritis
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and polyarticular juvenile idiopathic arthritis.
Xenleta (lefamulin) Tablets and Injection
Date of Approval: August 19, 2019
Company: Nabriva Therapeutics plc
Treatment for: Pneumonia
Xenleta (lefamulin) is a first-in-class, semi-synthetic pleuromutilin antibiotic for the treatment of community-acquired bacterial pneumonia (CABP).
Nourianz (istradefylline) Tablets
Date of Approval: August 27, 2019
Company: Kyowa Kirin, Inc.
Treatment for: Parkinson's Disease
Nourianz (istradefylline) is an adenosine A2A receptor antagonist indicated for use as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.
Gvoke (glucagon) Injection
Date of Approval: September 10, 2019
Company: Xeris Pharmaceuticals, Inc.
Treatment for: Hypoglycemia
Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of severe hypoglycemia in diabetes patients ages 2 years and older.
Ibsrela (tenapanor) Tablets
Date of Approval: September 12, 2019
Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome
Ibsrela (tenapanor) is a first-in-class, sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Rybelsus (semaglutide) Tablets
Date of Approval: September 20, 2019
Company: Novo Nordisk
Treatment for: Type 2 Diabetes
Rybelsus (semaglutide) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus.
Jynneos (smallpox and mpox vaccine) Injection
Date of Approval: September 24, 2019
Company: Bavarian Nordic A/S
Treatment for: Mpox, Smallpox Prophylaxis
Jynneos (smallpox and mpox vaccine, live, non-replicating) is a vaccine for the prevention of smallpox and mpox disease.
Aklief (trifarotene) Topical Cream
Date of Approval: October 4, 2019
Company: Galderma
Treatment for: Acne
Aklief (trifarotene) is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older.
Bonsity (teriparatide) Injection - formerly PF708
Date of Approval: October 4, 2019
Company: Pfenex Inc.
Treatment for: Osteoporosis
Bonsity (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
Scenesse (afamelanotide) Implant
Date of Approval: October 8, 2019
Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Prevention of Phototoxicity in Erythropoietic Protoporphyria
Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Beovu (brolucizumab-dbll) Injection
Date of Approval: October 7, 2019
Company: Novartis
Treatment for: Macular Degeneration, Diabetic Macular Edema
Beovu (brolucizumab-dbll) is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
Quzyttir (cetirizine hydrochloride) Injection
Date of Approval: October 4, 2019
Company: TerSera Therapeutics LLC
Treatment for: Urticaria
Quzyttir (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
Reyvow (lasmiditan) Tablets
Date of Approval: October 11, 2019
Company: Eli Lilly and Company
Treatment for: Migraine
Reyvow (lasmiditan) is a serotonin (5-HT)1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.
Secuado (asenapine) Transdermal System
Date of Approval: October 11, 2019
Company: Noven Pharmaceuticals, Inc.
Treatment for: Schizophrenia
Secuado (asenapine) is a transdermal atypical antipsychotic formulation indicated for the treatment of adults with schizophrenia.
Amzeeq (minocycline) Topical Foam
Date of Approval: October 18, 2019
Company: Foamix Pharmaceuticals
Treatment for: Acne
Amzeeq (minocycline) is a topical foam formulation of the approved tetracycline drug minocycline indicated for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules
Date of Approval: October 21, 2019
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.
Biorphen (phenylephrine hydrochloride) Injection
Date of Approval: October 21, 2019
Company: Eton Pharmaceuticals, Inc.
Treatment for: Hypotension
Biorphen (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension during anesthesia.
Vumerity (diroximel fumarate) Delayed-Release Capsules
Date of Approval: October 29, 2019
Company: Alkermes plc and Biogen
Treatment for: Multiple Sclerosis
Vumerity (diroximel fumarate) is a novel oral fumarate for the treatment of relapsing forms of multiple sclerosis (MS).
Talicia (amoxicillin, omeprazole and rifabutin) Delayed-Release Capsules
Date of Approval: November 4, 2019
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter Pylori Infection
Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a fixed-dose combination of two antibiotics, (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) for the treatment of Helicobacter pylori (H. pylori) infection.
Ziextenzo (pegfilgrastim-bmez) Injection
Date of Approval: November 4, 2019
Company: Sandoz, Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Hematopoietic Syndrome of Acute Radiation Syndrome
Ziextenzo (pegfilgrastim-bmez) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim).
Reblozyl (luspatercept-aamt) for Injection
Date of Approval: November 8, 2019
Company: Bristol Myers Squibb
Treatment for: Anemia in Beta-Thalassemia; Anemia in Lower-Risk Myelodysplastic Syndromes
Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for use in the treatment of anemia in patients with beta thalassemia and anemia in patients with myelodysplastic syndromes.
Brukinsa (zanubrutinib) Capsules
Date of Approval: November 14, 2019
Company: BeiGene, Ltd.
Treatment for: Mantle Cell Lymphoma, Waldenström Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma
Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor used for the treatment of mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma.
Fetroja (cefiderocol) Injection
Date of Approval: November 14, 2019
Company: Shionogi & Co., Ltd.
Treatment for: Complicated Urinary Tract Infections; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia
Fetroja (cefiderocol) is a siderophore cephalosporin indicated for the treatment of complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganisms.
Adakveo (crizanlizumab-tmca) Injection
Date of Approval: November 15, 2019
Company: Novartis
Treatment for: Sickle Cell Disease, Sickle Cell Anemia
Adakveo (crizanlizumab-tmca) is a P-selectin inhibitor for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).
Abrilada (adalimumab-afzb) Injection
Date of Approval: November 15, 2019
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
Abrilada (adalimumab-afzb) is a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Givlaari (givosiran) Injection
Date of Approval: November 20, 2019
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Acute Hepatic Porphyria
Givlaari (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA (siRNA) indicated for the treatment of adults with acute hepatic porphyria (AHP).
Xcopri (cenobamate) Tablets
Date of Approval: November 21, 2019
Company: SK Life Science, Inc.
Treatment for: Seizures
Xcopri (cenobamate) is an antiepileptic drug for the treatment of partial-onset seizures in adult patients.
Exservan (riluzole) Oral Film
Date of Approval: November 22, 2019
Company: Aquestive Therapeutics, Inc.
Treatment for: Amyotrophic Lateral Sclerosis
Exservan (riluzole) an oral film formulation of the approved glutamate Inhibitor riluzole for the treatment of patients with amyotrophic lateral sclerosis (ALS) patients who have difficulty swallowing.
Oxbryta (voxelotor) Tablets
Date of Approval: November 25, 2019
Company: Pfizer Inc.
Treatment for: Sickle Cell Disease
Oxbryta (voxelotor) is an oral, HbS (sickle hemoglobin) polymerization inhibitor for the treatment of patients with sickle cell disease (SCD).
RediTrex (methotrexate) /pro/reditrex-injection.html
Date of Approval: November 27, 2019
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis
RediTrex (methotrexate) is a folate analog metabolic inhibitor indicated for the management of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and psoriasis.
Avsola (infliximab-axxq) Injection
Date of Approval: December 6, 2019
Company: Amgen Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis
Avsola (infliximab-axxq) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Vyondys 53 (golodirsen) Injection
Date of Approval: December 12, 2019
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Vyondys 53 (golodirsen) is a phosphordiamidate morpholino oligimer for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
EluRyng (ethinyl estradiol and etonogestrel) Vaginal Ring
Date of Approval: December 11, 2019
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Birth Control
EluRyng (ethinyl estradiol/etonogestrel vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.
EluRyng is the first approved generic version of NuvaRing.
Nouress (cysteine hydrochloride) Injection
Date of Approval: December 13, 2019
Company: Avadel Pharmaceuticals plc
Treatment for: Total Parenteral Nutrition
Nouress (cysteine hydrochloride) is a sulfur-containing amino acid indicated for use as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition.
Padcev (enfortumab vedotin-ejfv) Lyophilized Powder for Injection
Date of Approval: December 18, 2019
Company: Astellas Pharma US, Inc.
Treatment for: Urothelial Carcinoma
Padcev (enfortumab vedotin-ejfv) is a Nectin-4 directed antibody-drug conjugate (ADC) for the treatment of urothelial cancer.
Arazlo (tazarotene) Lotion
Date of Approval: December 18, 2019
Company: Bausch Health Companies Inc.
Treatment for: Acne
Arazlo (tazarotene) is a lotion formulation of the approved retinoid tazarotene for the topical treatment of acne vulgaris in patients 9 years of age and older.
Ervebo (ebola zaire vaccine, live) Injection
Date of Approval: December 19, 2019
Company: Merck
Treatment for: Ebola Zaire Disease Prophylaxis
Ervebo (ebola zaire vaccine, live) is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.
Conjupri (levamlodipine maleate) Tablets
Date of Approval: December 19, 2019
Company: CSPC Pharmaceutical Group Limited
Treatment for: High Blood Pressure
Conjupri (levamlodipine maleate) is a calcium channel blocker indicated for the treatment of hypertension.
Enhertu (fam-trastuzumab deruxtecan-nxki) Injection
Date of Approval: December 20, 2019
Company: AstraZeneca and Daiichi Sankyo Company, Limited
Treatment for: Breast Cancer, Gastric Cancer, Non Small Cell Lung Cancer, Solid Tumors
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer, HER2-low or HER2-ultralow breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors.
Ubrelvy (ubrogepant) Tablets
Date of Approval: December 23, 2019
Company: AbbVie Inc.
Treatment for: Migraine
Ubrelvy (ubrogepant) is a potent, orally-administered CGRP receptor antagonist for the acute treatment of migraine with or without aura in adults.
Caplyta (lumateperone) Capsules
Date of Approval: December 20, 2019
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia, Bipolar Disorder
Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.
Dayvigo (lemborexant) Tablets
Date of Approval: December 20, 2019
Company: Eisai Co., Ltd.
Treatment for: Insomnia
Dayvigo (lemborexant) is dual orexin receptor antagonist (DORA) for the treatment of insomnia.
Ortikos (budesonide) Extended-Release Capsules
Date of Approval: June 13, 2019
Company: Ferring Pharmaceuticals Inc.
Treatment for: Crohn's Disease, Active, Crohn's Disease, Maintenance
Ortikos (budesonide) is an oral corticosteroid indicated for the treatment of mild to moderate active Crohn’s disease.
Polivy (polatuzumab vedotin-piiq) Injection
Date of Approval: June 10, 2019
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma
Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody and microtubule inhibitor conjugate used for the treatment of diffuse large B-cell lymphoma.
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