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

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

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
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