Drug Assignments

 

Drug Name Active Ingred Mfr Indication Approval
Date
AHFS Class NDA
Chem
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

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

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
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