Drug Assignments

 

Drug Name Active Ingred Mfr Indication Approval
Date
AHFS Class NDA
Sub
Type*
Appl No
Ontruzant® trastuzumab-dttb Samsung Bioepis HER2-overexpressing breast cancer, metastatic gastric or gastroesophageal junction adenocarcinoma 2019/01/18 10:00 - Antineoplastic Agents 761100
Tosymra® sumatriptan Dr Reddys migraine headaches 2019/01/25 28:32.28 - Selective Serotonin Agonists 3S 210884
Evekeo ODT® amphetamine sulfate Arbor attention deficit hyperactivity disorder (ADHD) 2019/01/30 28:20.04 - Amphetamines 3S 209905
Gloperba® colchicine Romeg prophylaxis of gout flares 2019/01/30 92:16 - Antigout Agents 3S 210942
Wixela Inhub fluticasone propionate; salmeterol xinafoate Mylan asthma; COPD 2019/01/30 68:04 - Adrenals; 12:12.08.12 - Selective beta2-Adrenergic Agonists 208891
Jeuveau® prabotulinumtoxinA-xvfs Evolus glabellar lines 2019/02/01 92:92 - Other Miscellaneous Therapeutic Agents 761085
AlyQ® tadalafil Teva pulmonary arterial hypertension (PAH) 2019/02/05 24:12.12 - Phosphodiesterase Type 5 Inhibitors; 48:48 - Vasodilating Agents 209942
Sylevia® ethinyl estradiol; levonorgestrel Sun birth control 2019/02/06 68:12 - Contraceptives 202988
Cablivi® caplacizumab-yhdp Ablynx acquired thrombotic thrombocytopenic purpura (aTTP) 2019/02/06 20:12.92 - Antithrombotic Agents, Misc 761112
Egaten® triclabendazole Novartis fascioliasis (liver fluke infestation) 2019/02/13 8:08 - Anthelmintics 1S 208711
Esperoct® antihemophilic factor (recombinant), glycopegylated-exei (INN: turoctocog alfa pegol) Novo Nordisk hemophilia A 2019/02/19 20:28.16 - Hemostatics 125671
Adhansia XR® methylphenidate Purdue Attention Deficit Hyperactivity Disorder (ADHD) 2019/02/27 28:20.32 - Respiratory and CNS Stimulants 3S 212038
Herceptin Hylecta® trastuzumab; hyaluronidase-oysk Genentech HER2-overexpressing breast cancer 2019/02/28 10:00 - Antineoplastic Agents 761106
Spravato® esketamine Janssen treatment-resistant depression (TRD) 2019/03/05 28:16.04.92 - Antidepressants, Miscellaneous 2P 211243
Trazimera® trastuzumab-qyyp Pfizer HER2-overexpressing breast cancer, metastatic gastric or gastroesophageal junction adenocarcinoma 2019/03/11 10:00 - Antineoplastic Agents 1 761081
Rocklatan® netarsudil; latanoprost Aerie reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension 2019/03/12 52:40.32 - Rho Kinase Inhibitors; 52:40.28 - Prostaglandin Analogs 4S 208259
Kemeya® drospirenone; ethinyl estradiol Sun birth control 2019/03/13 68:12 - Contraceptives 202138
Zykadia® ceritinib Novartis metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive 2019/03/18 10:00 - Antineoplastic Agents 3S 211225
Zulresso® brexanolone Sage postpartum depression (PPD) 2019/03/19 28:16.04.92 - Antidepressants, Misc 1P 211371
Sunosi® solriamfetol Jazz daytime sleepiness assoc with narcolepsy or obstructive sleep apnea 2019/03/20 28:20.80 - Wakefulness-promoting Agents 1S 211230
Mayzent® siponimod Novartis multiple sclerosis 2019/03/26 92:20 - Immunomodulatory Agents 1S 209884
Jatenzo® testosterone undecanoate Clarus testosterone replacement therapy 2019/03/27 68:08 - Androgens 3S 206089
Mavenclad® cladribine EMD Serono relapsing forms of multiple sclerosis (MS) 2019/03/29 92:44 - Immunosuppressive Agents 3S 022561
Avaclyr® acyclovir Fera acute herpetic keratitis (dendritic ulcers) with HSV-1 and HSV-2 infection 2019/03/29 52:04.20 - Antivirals 3S 202408
Duaklir® Pressair aclidinium; formoterol AstraZeneca maintenance of COPD 2019/03/29 12:08.08 - Antimuscarinics/Antispasmodics; 12:12.08.12 - Selective beta-2-Adrenergic Agonists 4S 210595
Asceniv® immune globulin intravenous, human-slra ADMA Biologics primary humoral immunodeficiency 2019/04/01 80:04 - Antitoxins and Immune Globulins 125590
Dovato® dolutegravir; lamivudine Viiv HIV-1 infection 2019/04/08 8:18.08.12 - HIV Integrase Inhibitors; 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors 4P 211994
Evenity® romosozumab-aqqg Amgen osteoporosis 2019/04/09 92:22 - Bone Anabolic Agents (new) 761062
Balversa® erdafitinib Janssen locally advanced or metastatic bladder cancer 2019/04/12 10:00 - Antineoplastic Agents 1P 212018
Elcys® cysteine hydrochloride Exela total parenteral nutrition 2019/04/16 40:12 - Replacement Preparations 5P 210660
Skyrizi® risankizumab-rzaa Abbvie plaque psoriasis 2019/04/23 84:92 - Skin and Mucous Membrane Agents, Misc 761105
Duobrii® halobetasol propionate; tazarotene Bausch plaque psoriasis 2019/04/25 84:06.08 - Corticosteroids; 84:92 - Skin and Mucous Membrane Agents, Misc 5S 209354
Eticovo® etanercept-ykro Samsung Bioepsis rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis (PsA), a ankylosing spondylitis (AS), plaque psoriasis (PsO) 2019/04/25 92:36 - Disease-modifying Antirheumatic Drugs; 92:20 - Immunomodulatory Agents (secondary) 761066
Zuragard® isopropyl alcohol 70% Zurex skin preparation for surgery 2019/04/26 84:04.92 - Local Anti-infectives, Misc 5S 210872
Dengvaxia® dengue tetravalent vaccine, live Sanofi Pasteur prevention of dengue disease caused by serotypes 1-4 in patients aged 9-16 2019/05/01 80:12 - Vaccines 125682
Qternmet XR® dapagliflozin; metformin; saxagliptin AstraZeneca AB type 2 diabetes mellitus 2019/05/02 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors; 68:20.04 - Biguanides; 68:20.05 - Dipeptidyl Peptidase-4 (DPP-4) Inhibitors 4S 210874
Vyndaqel® tafamidis meglumine FoldRx cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) 2019/05/03 24:04.92 - Cardiac Drugs, Misc 1P 211996
Vyndamax® tafamidis FoldRx cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) 2019/05/03 24:04.92 - Cardiac Drugs, Misc 1S 212161
Ruzurgi® amifampridine Jacobus Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to 17 2019/05/06 92:92 - Other Miscellaneous Therapeutic Agents 1O/P 209321
Nayzilam® midazolam nasal spray Proximagen intermittent, stereotypic episodes of frequent seizure activity 2019/05/17 28:12.08 - Benzodiazepines 3S/O 211321
Slynd® drospirenone Exeltis oral contraception 2019/05/23 68:12 - Contraceptives; 68:32 - Progestins 2/3S 211367
Piqray® alpelisib Novartis HR+HER2-, PIK3CA-mutated, advanced or metastatic breast cancer 2019/05/24 10:00 - Antineoplastic Agents 1S 212526
Zolgensma® onasemnogene abeparvovec-xioi Novartis spinal muscular atrophy (SMA) 2019/05/24 26:12 - Gene Therapy 125694
Polivy® polatuzumab vedotin-piiq Genentech diffuse large B-cell lymphoma (DLBCL) 2019/06/10 10:00 - Antineoplastic Agents 761121
Kanjinti® trastuzumab-anns Amgen HER2 breast cancer; HER2 metastatic gastric or gastroesophageal junction adenocarcinoma 2019/06/13 10:00 - Antineoplastic Agents 761073
Myxredlin® insulin human; sodium chloride Celerity diabetes mellitus 2019/06/20 68:20.08.08 - Short-acting Insulins 5S 208157
Vyleesi® bremelanotide acetate Amag hypoactive sexual desire disorder (HSDD) 2019/06/21 28:92 - Central Nervous System Agents, Misc 1S 210557
Zirabev® bevacizumab-bvzr Pfizer metastatic colorectal cancer; non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; in combination with other agents 2019/06/27 10:00 - Antineoplastic Agents 761099
Thiola EC® tiopronin Mission prevention of cystine stone formation with severe homozygous cystinuria 2019/06/28 92:92 - Other Miscellaneous Therapeutic Agents 3S 211843
Xpovio® selinexor Karyopharm relapsed refractory multiple myeloma 2019/07/03 10:00 - Antineoplastic Agents 1P 212306
Xembify® immune globulin subcutaneous, human-klhw Grifols primary humoral immunodeficiency 2019/07/03 80:04 - Antitoxins and Immune Globulins 125683
Katerzia® amlodipine oral suspension Silvergate hypertension; coronary artery disease (chronic stable angina, vasospastic angina) 2019/07/08 24:28.08 - Dihydropyridines; 24:12.92 - Vasodilating Agents, Misc 3S 211340
Recarbrio® imipenem-cilastatin; relebactam Merck complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) 2019/07/16 8:12.07.08 - Carbapenems 1/4P 212819
Drizalma Sprinkle® duloxetine Sun Pharma major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), chronic musculoskeletal pain 2019/07/19 28:16.04.16 - Selective Serotonin- and Norepinephrine-reuptake Inhibitors 5S 212516
Ruxience® rituximab-pvvr Pfizer non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) 2019/07/23 10:00 - Antineoplastic Agents 761103
Hadlima® adalimumab-bwwd Samsung Bioepis RA, JIA, PsA, AS, CD, UC, Ps 2019/07/23 92:36 - Disease-modifying Antirheumatic Drugs; 92:20 - Immunomodulatory Agents; 56:92 - GI Drugs, Misc 761059
Baqsimi® glucagon nasal powder Eli Lilly severe hypoglycemia 2019/07/24 68:22.12 - Glycogenolytic Agents 3S 210134
Angiomax RTU® bivalirudin Maia acute ischemic complications of PCI; heparin-induced thrombocytopenia (HIT) in patients undergoing PCI or cardiac surgery 2019/07/25 20:12.04.12 - Direct Thrombin Inhibitors 5S 211215
Accrufer® ferric maltol Shield TX iron deficiency 2019/07/25 20:04.04 - Iron Preparations 1S 212320
Nubeqa® darolutamide Bayer non-metastatic castration-resistant prostate cancer 2019/07/30 10:00 - Antioneoplastic Agents 1P 212099
Turalio® pexidartinib Daiichi symptomatic tenosynovial giant cell tumor (TGCT) 2019/08/02 10:00 - Antioneoplastic Agents 1P 211810
Wakix® pitolisant Bioprojet excessive daytime sleepiness (EDS) with narcolepsy 2019/08/14 28:20.80 - Wakefulness-promoting Agents 1S 211150
Pretomanid pretomanid Global Alliance for TB Drug Development drug-resistant tuberculosis 2019/08/14 8:16.04 - Antituberculosis Agents 1P 212862
Rozlytrek® entrectinib Genentech cancers with NTRK gene fusion; metastatic ROS1+ non-small cell lung cancer 2019/08/15 10:00 - Antineoplastic Agents 1P 212725
Inrebic® fedratinib Impact intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) 2019/08/16 10:00 - Antineoplastic Agents 1S 212327
Rinvoq® upadacitinib Abbvie rheumatoid arthritis 2019/08/16 92:36 - Disease-modifying Antirheumatic Drugs 1S 211675
Xenleta® lefamulin acetate Nabriva community-acquired bacterial pneumonia (CABP) 2019/08/19 8:12.28.26 - Pleuromutilins 1P 211672
Gallium Ga-68 Dotatoc gallium Ga-68 dotatoc University of Iowa use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) 2019/08/21 36:68 - Roentgenographic and Other Imaging Agents 1S 210828
Nourianz® istradefylline Kyowa Kirin add-on treatment for Parkinson's disease 2019/08/27 28:92 - CNS Agents, Miscellaneous 1S 022075
Gvoke® glucagon Xeris severe hypoglycemia 2019/09/10 68:22.12 - Glycogenolytic Agents 3S 212097
Ibsrela® tenapanor Ardelyx irritable bowel syndrome with constipation (IBS-C) 2019/09/12 56:92 - GI Drugs, Misc 1S 211801
Ozobax® baclofen Metacel spasticity resulting from multiple sclerosis 2019/09/18 12:20.12 - GABA-derivative Skeletal Muscle Relaxants 3S 208193
Rybelsus® semaglutide Novo Nordisk type 2 diabetes mellitus 2019/09/20 68:20.06 - Incretin Mimetics 3P 213051
Jynneos® Smallpox and Monkeypox Vaccine Live Bavarian Nordic prevention of smallpox and monkeypox disease 2019/09/24 80:12 - Vaccines 125678
Hemady® dexamethasone Dexcel multiple myeloma 2019/10/03 68:04 - Adrenals 1S/O 211379
Quzyttir® cetirizine JDP acute urticaria 2019/10/04 4:08 - Second Generation Antihistamines 3S 211415
Aklief® trifarotene Galderma acne vulgaris 2019/10/04 84:92 - Skin and Mucous Membrane Agents, Misc 1S 211527
Bonsity® teriparatide Pfenex osteoporosis 2019/10/04 68:24.08 - Parathyroid Agents 5S 211939
Beovu® brolucizumab-dbll Novartis wet age-related macular degeneration (AMD) 2019/10/07 52:92 - EENT Drugs, Misc 761125
Scenesse® afamelanotide Clinuvel prevent phototoxic reactions related to erythropoietic protoporphyria 2019/10/08 84:92 - Skin and Mucous Membrane Agents, Misc 1P/O 210797
Fluorodopa F18® fluorodeoxyphenylalanine Feinstein positron emission tomography (PET) in diagnosing Parkinsonian Syndrome(PS) 2019/10/10 36:68 - Roentgenographic and Other Imaging Agents 1S 200655
Reyvow® lasmiditan Eli Lilly migraine headaches 2019/10/11 28:32.28 - Selective Serotonin Agonists 1S 211280
Secuado® asenapine transdermal system Hisamitsu schizophrenia and bipolar disorder 2019/10/11 28:16.08.04 - Atypical Antipsychotics 3S 212268
Amzeeq® minocycline topical foam Foamix acne vulgaris 2019/10/18 3S 212379
Trikafta® elexacaftor, tezacaftor, ivacaftor Vertex cystic fibrosis (CF) 2019/10/21 48:14.04 - Cystic Fibrosis Transmembrane Conductance Regulator Correctors (1); 48:14.12 - Cystic Fibrosis Transmembrane Conductance Regulator Potentiators (2) 1P/O 212273
Biorphen® phenylephrine Sintetica clinically important hypotension resulting primarily from vasodilation during anesthesia 2019/10/21 12:12.04 - alpha-Adrenergic Agonists 5S 212909
Vumerity® diroximel fumarate Alkermes relapsing-remitting multiple sclerosis (MS) 2019/10/29 92:20 - Immunomodulatory Agents 2S 211855
Talicia® omeprazole; amoxicillin; rifabutin Redhill Helicobacter pylori infection 2019/11/04 56:28.92 - Antiulcer Agents and Acid Suppressants, Misc 4P 213004
Ziextenzo® pegfilgrastim-bmez Sandoz chemotherapy-induced neutropenia 2019/11/04 20:16 - Hematopoietic Agents 761045
Absorica® isotretinoin Sun severe recalcitrant nodular acne 2019/11/05 84:92 - Skin and Mucous Membrane Agents, Misc S 211913
ExEm Foam® air polymer-type A Giskit sonohysterosalpingography 2019/11/07 36:68 - Roentgenographic and Other Imaging Agents 1S 212279
Reblozyl® luspatercept-aamt Celgene anemia due to beta thalassemia 2019/11/08 20:16 - Hematopoietic Agents 761136
Brukinsa® zanubrutinib Beigene mantle cell lymphoma (MCL) 2019/11/14 10:00 - Antineoplastic Agents 1P/O 213217
Fetroja® cefiderocol sulfate tosylate Shionogi complicated urinary tract infections (cUTI) 2019/11/14 8:12.06.28 - Siderophore Cephalosporins (NEW) 1P 209445
Abrilada® adalimumab-afzb Pfizer RA, JIA, PsA, AS, CD, UC, Ps 2019/11/15 92:36 - Disease-modifying Antirheumatic Drugs; 92:20 - Immunomodulatory Agents; 56:92 - GI Drugs, Misc 761118
Adakveo® crizanlizumab-tmca Novartis vaso-occlusive crisis assoc with sickle cell disease 2019/11/15 20:92 - Blood Formation, Coagulation, and Thrombosis Agents, Misc 761128
Givlaari® givosiran Alnylam acute hepatic porphyria 2019/11/20 92:92 - Other Miscellaneous Therapeutic Agents 1P/O 212194
Xcopri® cenobamate SK Life partial-onset seizures 2019/11/21 28:12.92 - Anticonvulsants, Misc 1S 212839
Exservan® riluzole Aquestive amyotrophic lateral sclerosis (ALS) 2019/11/22 28:92 - Central Nervous System Agents, Misc 3S/O 212640
Oxbryta® voxelotor Global Blood Therapeutics sickle cell disease (SCD) 2019/11/25 20:92 - Blood Formation, Coagulation, and Thrombosis Agents, Misc 1S 213137
Reditrex® methotrexate Cumberland RA, pJIA, PA 2019/11/27 92:20 - Immunomodulatory Agents 5S 210737
Avsola® infliximab-axxq Amgen RA, JIA, PsA, AS, CD, pCD, UC, pUC, Ps 2019/12/06 92:36 - Disease-modifying Antirheumatic Drugs; 92:20 - Immunomodulatory Agents; 56:92 - GI Drugs, Misc; 84:92 - Skin and Mucous Membrane Agents, Misc 761086
Vyondys 53® golodirsen Sarepta Duchenne muscular dystrophy (DMD) 2019/12/12 92:18 - Antisense Oligonucleotides 1P 211970
Nouress® cysteine hydrochloride Avadel total parenteral nutrition 2019/12/13 40:12 - Replacement Preparations 5S 212535
Padcev® enfortumab vedotin-ejfv Astellas advanced urothelial cancer 2019/12/18 10:00 - Antineoplastic Agents 761137
Arazlo® tazarotene Dow acne vulgaris 2019/12/18 84:92 - Skin and Mucous Membrane Agents, Misc 3S 211882
Conjupri® levamlodipine CSPC Ouyi Pharma hypertension 2019/12/19 24:28.08 - Dihydropyridines 2/3S 212895
Genosyl® nitric oxide Vero hypoxic respiratory failure due to pulmonary hypertension 2019/12/20 24:12.08 - Nitrates and Nitrites 5S 202860
Caplyta® lumateperone Intra-cellular Therapies schizophrenia 2019/12/20 28:16.08.04 - Atypical Antipsychotics 1S 209500
TissueBlue® brilliant blue G (BBG) Dutch Ophthalmic selectively stain the internal limiting membrane 2019/12/20 36:58 - Ocular Disorders 1P 209569
Dayvigo® lemborexant Eisai insomnia 2019/12/20 28:24.92 - Anxiolytics, Sedatives, and Hypnotics; Misc 1S 212028
Enhertu® fam-trastuzumab deruxtecan-nxki Daiichi Sankyo HER2+ breast cancer 2019/12/20 10:00 - Antineoplastic Agents 761139
Ubrelvy® ubrogepant Allergan migraine headaches 2019/12/23 28:32.12 - Calcitonin Gene-related Peptide (CGRP) Antagonists 1S 211765

Drug Classification Changes

 

AHFS Class Change Date Change Description
28:32.12 - Calcitonin Gene-related Peptide (CGRP) Antagonists 2019/02/25 New subclass
92:22 - Bone Anabolic Agents 2019/04/10 New subclass
8:12.28.26 - Pleuromutilins 2019/08/19 New subclass
8:12.06.28 - Siderophore Cephalosporins 2019/11/14 New subclass

Drug Reassignments

 

Drug Name(s) Active Ingred Change
Date
Old AHFS Class New AHFS Class
Arixtra® fondaparinux sodium 2019/02/25 20:12.04.14 - Direct Factor Xa Inhibitors 20:12.04.92 - Anticoagulants, Misc
Seysara® sarecycline 2019/02/25 8:12.24 - Tetracyclines 8:12.24.04 - Aminomethylcyclines
Aimovig® erenumab-aooe 2019/02/25 28:32.92 - Antimigraine Agents, Misc 28:32.12 - Calcitonin Gene-related Peptide (CGRP) Antagonists
Ajovy® fremanezumab-vfrm 2019/02/25 28:32.92 - Antimigraine Agents, Misc 28:32.12 - Calcitonin Gene-related Peptide (CGRP) Antagonists
Emgality® galcanezumab-gnlm 2019/02/25 28:32.92 - Antimigraine Agents, Misc 28:32.12 - Calcitonin Gene-related Peptide (CGRP) Antagonists
Forteo® teriparatide 2019/04/10 68:24.08 - Parathyroid Agents 68:24.08 - Parathyroid Agents; 92:22 - Bone Anabolic Agents
Tymlos® abaloparatide 2019/04/10 68:24.08 - Parathyroid Agents 68:24.08 - Parathyroid Agents; 92:22 - Bone Anabolic Agents
Natpara® parathyroid hormone 2019/04/10 68:24.08 - Parathyroid Agents 68:24.08 - Parathyroid Agents; 92:22 - Bone Anabolic Agents
Cambia® diclofenac potassium for oral solution 2019/05/17 28:08.04.92 - Other Nonsteroidal Anti-inflammatory Agents (NSAIAs) 28:08.04.92 - Other Nonsteroidal Anti-inflammatory Agents (NSAIAs); 28:32.92 - Antimigraine Agents, Misc
Zelnorm® tegaserod 2019/07/22 56:92 - GI Drugs, Misc 56:32 - Prokinetic Agents