Drug Assignments

 

Drug Name Active Ingred Mfr Indication Approval
Date
AHFS Class NDA
Sub
Type*
Appl No
Lutathera® lutetium Lu-177 dotatate Advanced Accelerator Applications somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) 2018/01/26 10:00 - Antineoplastic Agents; 78:00 - Radioactive Agents 1P 208700
Firvanq® vancomoycin RxM Therapeutics C. diff-associated diarrhea, enterocolitis (S. aureus [incl MRSA]) 2018/01/26 8:12.28.16 - Glycopeptides 5P 208910
Symfi Lo® efavirenz; lamivudine; tenofovir disoproxil Mylan HIV-1 infection 2018/02/05 8:18.08.16 - HIV Nonnucleoside Reverse Transcriptase Inhibitors; 8:18.08.20 HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors 3P 208255
Biktarvy® bictegravir; emtracitabine; tenofovir alafenamide Gilead HIV-1 infection 2018/02/07 8:18.08.12 - HIV Integrase Inhibitors; 8:18.08.20 HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors 1/4P 210251
Symdeko® tezacaftor; ivacaftor Vertex cystic fibrosis (CF) with mutation of CFTR gene 2018/02/12 48:14.04 - Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Correctors; 48:14.12 - Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Potentiators 1P 210491
Erleada® apalutamide Janssen non-metastatic castration-resistant prostate cancer 2018/02/14 10:00 - Antineoplastic Agents 1P 210951
Osmolex ER® amantadine Osmotica Pharm Parkinsons; drug-induced extrapyramidal reactions 2018/02/16 28:36.04 - Adamantanes 3S 209410
Lusduna® insulin glargine Merck Sharp Dohme diabetes 2018/02/22 68:20.08 - Insulins 5S 209764
Apadaz® benzhydrocodone; acetaminophen KemPharm acute severe pain 2018/02/23 28:08.08 - Opiate Agonists; 28:08.92 - Analgesics and Antipyretics, Misc 4S 208653
Cimduo® lamivudine; tenofovir disoproxil fumerate Matrix HIV-1 infection 2018/02/28 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NNRTI) 4P 022141
ZTLido® lidocaine Scilex pain associated with post-herpetic neuralgia (PHN) 2018/02/28 72:00 - Local Anesthetics 5S 207962
Trogarzo® ibalizumab-uiyk Taimed HIV-1 infection with multidrug resistance 2018/03/06 8:18.08.04 - HIV Entry and Fusion Inhibitors 1/O 761065
Ilumya® tildrakizumab-asmn MSD / Sun Pharma plaque psoriasis 2018/03/20 84:92 - Skin and Mucous Membrane Agents, Misc 1 761067
Symfi® efavirenz; lamivudine; tenofovir disoproxil Matrix HIV-1 infection 2018/03/22 8:18.08.16 - HIV Nonnucleoside Reverse Transcriptase Inhibitors; 8:18.08.20 HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors 4 022142
Tavalisse® fostamatinib Rigel chronic immune thrombocytopenia (ITP) 2018/04/17 20:92 - Blood Formation, Coagulation, and Thrombosis Agents; Misc 1S 209299
Crysvita® burosumab-twza Ultragenyx X-linked hypophosphatemia (a vitamin D-resistant form of rickets) 2018/04/17 40:92 - Electrolytic, Caloric, and Water Balance Agents; Misc 1S 761068
Akynzeo® for Injection fosnetupitant; palonosetron Helsinn acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy 2018/04/19 56:22.32 - Neurokinin-1 Receptor Antagonists; 56:22.20 - 5-HT3 Receptor Antagonists 1S 210493
Jynarque® tolvaptan Otsuka autosomal dominant polycystic kidney disease (ADPKD) 2018/04/23 40:28.28 - Vasopressin Antagonists 10P/O 204441
Andexxa® factor Xa (recombinant), inactivated-zhzo Portola reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding 2018/05/03 20:28.92 - Antihemorrhagic Agents, Misc 1 125586
Plenvu® PEG 3350; sod ascorbate; sod sulfate; ascorbic acid; sod chloride; pot chloride Northstar colon preparation for colonoscopy 2018/05/04 56:12 - Cathartics and Laxatives 2S 209381
Retacrit® epoetin alfa-epbx Hospira anemia 2018/05/15 20:16 - Hematopoietic Agents 125545
Lucemyra® lofexidine US Worldmeds mitigation of opioid withdrawal symptoms 2018/05/16 12:12.04 - alpha-Adrenergic Agonists 1P 209229
Aimovig® erenumab-aooe Amgen migraine headaches 2018/05/17 28:32.92 - Antimigraine Agents, Misc 1 761077
Lokelma® sodium zirconium cyclosilicate AstraZeneca hyperkalemia 2018/05/18 40:18.18 - Potassium-removing Agents 1S 207078
Doptelet® avatrombopag Akarx thrombocytopenia 2018/05/21 20:16 - Hematopoietic Agents 1P 210238
Yonsa® abiraterone Sun Pharma metastatic castration-resistant prostate cancer (CRPC) 2018/05/22 10:00 - Antineoplastic Agents 5S 210308
Palynziq® pegvaliase-pqpz Biomarin hyperphenylalaninaemia in patients with phenylketonuria (PKU) 2018/05/24 44:00 - Enzymes 761079
Imvexxy® estradiol Therapeutics MD moderate to severe dyspareunia due to menopause 2018/05/29 68:16.04 - Estrogens 5S 208564
Olumiant® baricitinib Eli Lilly moderate to severe rheumatoid arthritis 2018/05/31 92:36 - Disease-modifying Antirheumatic Drugs (DMARD) 1S 207924
Consensi® amlodipine; celecoxib Kitov combination therapy for hypertension and osteoarthritis 2018/05/31 24:28.08 - Dihydropyridines; 28:08.04.08 - Cyclooxygenase-2 (COX-2) Inhibitors 4S 210045
Fulphila® pegfilgrastim-jmdb Mylan febrile neutropenia 2018/06/04 20:16 - Hematopoietic Agents 761075
moxidectin moxidectin Medicines Development onchocerciasis 2018/06/13 8:08 - Anthelmintics 1P/O 210867
Lymepak® doxycycline hyclate Chartwell early Lyme disease 2018/06/15 8:12.24 - Tetracyclines 5S 209844
Nocdurna® desmopressin Ferring nocturia due to nocturnal polyuria 2018/06/21 68:28 - Pituitary 5S 022517
Ablysinol® dehydrated alcohol Belcher alcohol septal ablation 2018/06/21 24:16 - Sclerosing Agents 5S 207987
Zemdri® plazomicin Achaogen complicated urinary tract infections (cUTI) including pyelonephritis 2018/06/25 8:12.02 - Aminoglycosides 1P 210303
Epidiolex® cannabidiol GW Research seizures associated with Lennox-Gastaut or Dravet syndrome 2018/06/25 28:12.92 - Anticonvulsants, Misc 1P 210365
Braftovi® encorafenib Array Biopharma unresectable or metastatic melanoma with a BRAF V600E or V600K mutation; in combination with binimetinib 2018/06/27 10:00 - Antineoplastic Agents 1/4S 210496
Mektovi® binimetinib Array Biopharma unresectable or metastatic melanoma with a BRAF V600E or V600K mutation; in combination with encorafenib 2018/06/27 10:00 - Antineoplastic Agents 1/4S 210498
Qbrexza® glycopyrronium tosylate Dermira primary axillary hyperhidrosis 2018/06/28 84:92 - Skin and Mucous Membrane Agents, Misc; 12:08.08 - Antimuscarinics/Antispasmodics 3S 210361
TPOXX® tecovirimat Siga smallpox disease caused by variola virus 2018/07/13 8:18.92 - Antivirals, Misc 1P 208627
Symtuza® darunavir; cobicistat; emtracitabine; tenofovir alafenamide Janssen HIV-1 infection 2018/07/17 8:18.08.08; 92:92; 8:18.08.20; 8:18.08.20 4S 210455
Krintafel® tafenoquine GlaxoSmithKline radical cure (prevention of relapse) of Plasmodium vivax malaria 2018/07/20 8:30.08 - Antimalarials 1P 210795
Tibsovo® ivosidenib Agios relapsed or refractory acute myeloid leukemia (AML) 2018/07/20 10:00 - Antineoplastic Agents 1P 211192
Orilissa® elagolix Abbvie management of pain associated with endometriosis 2018/07/23 68:18.04 - Antigonadotropins 1P 210450
Omegaven® fish oil triglycerides Fresenius Kabi source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC) 2018/07/27 40:20 - Caloric Agents 1P 210589
Azedra® iobenguane I-131 Progenics pheochromocytoma or paraganglioma 2018/07/31 10:00 - Antineoplastic Agents 5P 209607
Mulpleta® lusutrombopag Shionogi thrombocytopenia in adults with chronic liver disease 2018/07/31 20:16 - Hematopoietic Agents 1P 210923
Poteligeo® mogamulizumab-kpkc Kyowa Kirin relapsed or refractory mycosis fungoides or S├ęzary syndrome 2018/08/08 10:00 - Antineoplastic Agents 1P 761051
Arakoda® tafenoquine 60 Degrees prophylaxis of malaria 2018/08/08 8:30.08 - Antimalarials 5S 210607
Galafold® migalastat Amicus Fabry disease 2018/08/10 92:92 - Other Miscellaneous Therapeutic Agents 1P 208623
Annovera® segesterone; ethinyl estradiol Population Council combination hormonal contraceptive (CHC) 2018/08/10 68:12 - Contraceptives 1S 209627
Onpattro® patisiran Alnylam polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) 2018/08/10 92:92 - Other Miscellaneous Therapeutic Agents 1P/O 210922
Cequa® cyclosporine Sun Pharma keratoconjunctivitis sicca (dry eye) 2018/08/14 52:08.92 - Anti-inflammatory Agents, Misc 5S 210913
Diacomit® stiripentol Biocodex SA seizures assoc with Dravet syndrome together with clobazam 2018/08/20 28:12.92 - Anticonvulsants, Misc 1P/O 206709
Inveltys® loteprednol etabonate Kala post-operative inflammation and pain following ocular surgery 2018/08/22 52:08.08 - Corticosteroids 5 210565
Oxervate® cenegermin Dompé neurotrophic keratitis 2018/08/22 52:92 - EENT Drugs, Misc 1P/O 761094
Takhzyro® lanadelumab-flyo Dyax hereditary angioedema 2018/08/23 92:32 - Complement Inhibitors 1 761090
Altreno® tretinoin Dow acne vulgaris 2018/08/23 84:16 - Cell Stimulants and Proliferants 5 209353
Xerava® eravacycline Tetraphase complicated intra-abdominal infections except cUTI 2018/08/27 8:12.24.08 - Fluorocyclines (new class) 1P 211109
Jivi® Antihemophilic factor (recombinant), PEGylated-aucl Bayer bleeding management/prophylaxis with hemophilia A (congenital Factor VIII deficiency) 2018/08/29 20:28.16 - Hemostatics 125661
Pifeltro® doravirine Merck Sharp Dohme HIV-1 infection 2018/08/30 8:18.08.16 - HIV Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs) 1S 210806
Delstrigo® doravirine; lamivudine; tenofovir (TDF) Merck Sharp Dohme HIV-1 infection 2018/08/30 8:18.08.16 - HIV Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs); 8:18.08.20; 8:18.08.20 1/4S 210807
Sympazan® clobazam Aquestive seizures associated with Lennox-Gastaut Syndrome 2018/08/31 28:12.08 - Benzodiazepines 3S 210833
Tiglutik® riluzole Italfarmaco SPA amyotrophic lateral sclerosis (ALS) 2018/09/05 28:92 - Central Nervous System Agents, Misc 3S 209080
Cassipa® buprenorphine; naloxone Teva opioid dependence 2018/09/07 28:08.12 - Opiate Partial Agonists; 28:10 - Opiate Antagonists 5S 208042
Lumoxiti® moxetumomab pasudotox-tdfk AstraZeneca relapsed or refractory hairy cell leukemia (HCL) 2018/09/13 10:00 - Antineoplastic Agents 1 761104
Ajovy® fremanezumab-vfrm Teva migraine headaches 2018/09/14 28:32.92 - Antimigraine Agents, Misc 1 761089
Copiktra® duvelisib Verastem relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) or follicular lymphoma (FL) 2018/09/24 10:00 - Antineoplastic Agents 1P 211155
Vizimpro® dacomitinib Pfizer first-line treatment of metastatic non-small cell lung cancer (NSCLC) with EGFR mutations 2018/09/27 10:00 - Antineoplastic Agents 1/4P 211288
Emgality® galcanezumab-gnlm Eli Lilly migraine headaches 2018/09/27 28:32.92 - Antimigraine Agents, Misc 1 761063
Arikayce® amikacin liposome inhalation Insmed refractory Mycobacterium avium complex (MAC) lung disease 2018/09/28 8:12.02 - Aminoglycosides 3O/P 207356
Libtayo® cemiplimab-rwlc Regeneron metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC 2018/09/28 10:00 - Antineoplastic Agents 1 761097
Seysara® sarecycline Allergan inflammatory lesions of non-nodular moderate to severe acne vulgaris 2018/10/01 8:12.24 - Tetracyclines 1S 209521
Nuzyra® omadacycline Paratek community-acquired bacterial pneumonia (CABP); acute bacterial skin and skin structure infections (ABSSSI) 2018/10/02 8:12.24.04 - Aminomethylcyclines (new class) 1P 209816, 209817
Tegsedi® inotersen Ionis polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) 2018/10/05 92:18 - Antisense Oligonucleotides (ASO) 1P 211172
Revcovi® elapegademase-lvlr Leadiant adenosine deaminase severe combined immune deficiency (ADA-SCID) 2018/10/05 44:00 - Enzymes 1 761092
Yutiq fluocinolone acetonide Eyepoint chronic non-infectious posterior segment uveitis 2018/10/12 52:08.08 - Corticosteroids (EENT) 5S 210331
Talzenna® talazoparib Pfizer deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer 2018/10/16 10:00 - Antineoplastic Agents 1S 211651
Qmiiz® ODT meloxicam Tersera osteoarthritis (OA), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) 2018/10/19 28:08.04.92 - Other Nonsteroidal Anti-inflammatory Agents 3S 211210
Khapzory® levoleucovorin Spectrum rescue after high-dose MTX therapy; folic acid antagonists overdosage; metastatic colorectal cancer in combo with fluorouracil 2018/10/19 92:12 - Antidotes 2S 211226
Xofluza® baloxavir Shionogi acute uncomplicated influenza virus infection 2018/10/24 8:18.92 - Antivirals, Misc 1P 210854
Bijuva® estradiol; progesterone Therapeutics MD moderate to severe vasomotor symptoms due to menopause 2018/10/28 68:16.04 - Estrogens; 68:32 - Progestins 4S 210132
Hyrimoz® adalimumab-adaz Sandoz RA, JIA, PsA, AS, CD, UC, Ps 2018/10/30 92:36 - Disease-modifying Antirheumatic Drugs; 92:20 - Immunomodulatory Agents; 56:92 - GI Drugs, Misc 2S 761071
Sympazan® clobazam Aquestive seizures associated with Lennox-Gastaut Syndrome (LGS) 2018/11/01 28:12.08 - Benzodiazepines 3S 210833
Dsuvia® sufentanil AcelRx acute severe pain 2018/11/02 28:08.08 - Opiate Agonists 3S 209128
Lorbrena® lorlatinib Pfizer anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) 2018/11/02 10:00 - Antineoplastic Agents 1P 210868
Udenyca® pegfilgrastim-cbqv Coherus febrile neutropenia 2018/11/02 20:16 - Hematopoietic Agents 761039
Yupelri® revefenacin Theravance maintenance of chronic obstructive pulmonary disease (COPD) 2018/11/09 12:08.08 - Antimuscarinics/Antispasmodics 1S 210598

Drug Classification Changes

 

AHFS Class Change Date Change Description
84:06.08 - Corticosteroids 2017/12/15 New subclass
84:06.20 - Nonsteroidal Anti-inflammatory Agents 2017/12/15 New subclass
84:06.92 - Anti-inflammatory Agents, Miscellaneous 2017/12/15 New subclass
68:44 - Renin-Angiotensin-Aldosterone System (RAAS) 2017/12/21 New subclass
40:92 - Electrolytic, Caloric, and Water Balance Agents; Misc 2018/04/01 New subclass
8:12.24.08 - Fluorocyclines 2018/08/27 New subclass
68:20.08.04 - Rapid-Acting Insulins 2018/09/25 New subclass
68:20.08.08 - Short-Acting Insulins 2018/09/25 New subclass
68:20.08.12 - Intermediate-Acting Insulins 2018/09/25 New subclass
68:20.08.16 - Long-Acting Insulins 2018/09/25 New subclass
8:12.24.04 - Aminomethylcyclines 2018/10/03 New subclass
52:40.32 - Rho Kinase Inhibitors 2018/11/05 New subclass
36:68 - Roentgenographic and Other Imaging Agents 2018/11/05 Name change

Drug Reassignments

 

Drug Name(s) Active Ingred Change
Date
Old AHFS Class New AHFS Class
Eucrisa® crisaborole 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.92 - Anti-inflammatory Agents, Miscellaneous
Aclovate® alclometasone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Cyclocort® amcinonide 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Alphatrex®, Betatrex®, Beta-Val®, Diprolene®, Luxiq®, Maxivate® betamethasone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Clobevate®, Clobex®, Cormax®, Embeline®, Olux®, Temovate® clobetasol 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Cloderm® clocortolone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Desonate®, DesOwen®, Verdeso® desonide 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Topicort® desoximetasone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Psorcon® diflorasone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Capex®, Derma-Smoothe/FS®, Lidex®, Lidex-E®, Synalar®, Synemol® fluocinolone/fluocinonide 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Cordran® flurandrenolide 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Halog®, Halog-E® halcinonide 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Ultravate® halobetasol 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Ala-Cort®, Anucort-HC®, Anusert-HC®, Anusol-HC®, Cetacort®, Cortizone®, Dermacort®, Lanacort®, Proctocort®, Sarnol-HC®, Texacort®, Westcort® hydrocortisone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Elocon® mometasone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Dermatop® prednicarbate 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Aristocort®, Flutex®, Kenalog®, Triacet® triamcinolone 2017/12/15 84:06 - Anti-inflammatory Agents 84:06.08 - Corticosteroids
Pennsaid®, Solaraze® 3% Gel, Voltaren® 1% Gel diclofenac sodium 2017/12/15 84:92 - Skin and Mucous Membrane Agents, Misc 84:06.20 - Nonsteroidal Anti-inflammatory Agents
Inflectra®, Ixifi®, Remicade®, Renflexis® infliximab, -abda, -dyyb, -qbtx 2018/05/14 56:92, 92:20, 92:36 56:92, 84:92, 92:20, 92:36
Simponi®, Simponi Aria® golimumab 2018/05/14 92:20, 92:36 56:92, 92:20, 92:36
Otezla® apremilast 2018/05/14 84:92, 92:36 84:92, 92;20, 92:36
Afrezza® insulin human inhalation powder 2018/09/25 68:20.08 - Insulins 68:20.08.04 - Rapid-Acting Insulins
Fiasp®, NovoLOG®, NovoLOG® Mix 70/30 (combination), Ryzodeg® 70/30 (combination) insulin aspart 2018/09/25 68:20.08 - Insulins 68:20.08.04 - Rapid-Acting Insulins
Apidra® insulin glulisine 2018/09/25 68:20.08 - Insulins 68:20.08.04 - Rapid-Acting Insulins
AdmeLOG®, HumaLOG®, HumaLOG® Mix 75/25 (combination) insulin lispro 2018/09/25 68:20.08 - Insulins 68:20.08.04 - Rapid-Acting Insulins
HumuLIN® N, HumuLIN® R, NovoLIN® N, NovoLIN® R, HumuLIN® 70/30 (combination), NovoLIN® 70/30 (combination) insulin human 2018/09/25 68:20.08 - Insulins 68:20.08.08 - Short-Acting Insulins
HumuLIN® 70/30 (combination), NovoLIN® 70/30 (combination) insulin human isophane (NPH) 2018/09/25 68:20.08 - Insulins 68:20.08.12 - Intermediate-Acting Insulins
Tresiba®, Ryzodeg® 70/30 (combination), Xultophy® 100/3.6 (combination) insulin degludec 2018/09/25 68:20.08 - Insulins 68:20.08.16 - Long-Acting Insulins
Levemir® insulin detemir 2018/09/25 68:20.08 - Insulins 68:20.08.16 - Long-Acting Insulins
Basaglar®, Lantus®, Lusduna®, Toujeo®, Soliqua® 100/33 (combination) insulin glargine 2018/09/25 68:20.08 - Insulins 68:20.08.16 - Long-Acting Insulins
Rhopressa® netarsudil 2018/11/05 52:40.92 - Antiglaucoma Agents, Misc 52:40.32 - Rho Kinase Inhibitors
Gleolan® aminolevulinic acid oral solution 2018/11/05 36:68 - Roentgenographic and Other Imaging Agents