Drug Assignments

 

Drug Name Active Ingred Mfr Indication Approval
Date
AHFS Class NDA
Chem
Type*
Appl No
Arymo ER® morphine sulfate Egalet severe pain requiring daily, around-the-clock, long-term opioid treatment 2017/01/09 28:08.08 - Opiate Agonists 5S 208603
Nitrous Oxide nitrous oxide Matheson Tri-Gas general anesthesia; analgesia 2017/01/09 28:04.16 - Inhalation Anesthetics 209989
Esbriet® pirfenidone Genentech idiopathic pulmonary fibrosis (IPF) 2017/01/11 48:02 - Antifibrotic Agents 3S 208780
Vantrela ER® hydrocodone Teva pain 2017/01/17 28:08.08 - Opiate Agonists 3S 207975
Rhofade® oxymetazoline Allergan persistent facial erythema associated with rosacea 2017/01/18 84:92 - Skin and Mucous Membrane Agents, Misc 10S 208552
Trulance® plecanatide Synergy chronic idiopathic constipation (CIC) 2017/01/19 56:92 - GI Drugs, Miscellaneous 1S 208745
Tepadina® thiotepa Adienne SA reduce risk of graft rejection; adenocarcinoma of the breast or ovary; superficial papillary carcinoma of the urinary bladder; controlling intracavitary effusions 2017/01/26 10:00 - Antineoplastic Agents 5S 208264
ArmonAirTM Respiclick® fluticasone propionate Teva asthma 2017/01/27 68:04 - Adrenals 5S 208798
AirDuoTM Respiclick® fluticasone propionate; salmeterol Teva asthma 2017/01/27 68:04 - Adrenals; 12:12.08.12 - Selective beta-2-Adrenergic Agonists 4S 208799
Corphedra® ephedrine Par anesthesia-induced hypotension 2017/01/27 12:12.12 - alpha- and beta-Adrenergic Agonists 5S 208943
Parsabiv® etelcalcetide Kai secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis 2017/02/07 92:92 - Other Miscellaneous Therapeutic Agents 1S 208325
Emflaza® deflazacort Marathon Duchenne muscular dystrophy (DMD) 2017/02/09 68:04 - Adrenals 1P 208684
Siliq® brodalumab Valeant plaque psoriasis 2017/02/15 84:92 - Skin and Mucous Membrane Agents, Misc 761032
Qtern® dapagliflozin; saxagliptin AstraZeneca type 2 diabetes mellitus 2017/02/27 68:20.18 - SGLT-2 Inhibitors; 68:20.05 - DPP-4 Inhibitors 4S 209091
Xermelo® telotristat ethyl Lexicon Pharma carcinoid syndrom diarrhea 2017/02/28 56:08 - Antidiarrhea Agents 1S 208794
Noctiva® desmopressin acetate Serenity nocturnal polyuria 2017/03/03 68:28 - Pituitary 5S 201656
Kisqali® ribociclib Novartis HR+/HER2- advanced or metastatic breast cancer 2017/03/13 10:00 - Antineoplastic Agents 1P 209092
Xadago® safinamide Newron Parkinson's disease 2017/03/21 28:36.32 - Monoamine Oxidase B Inhibitors 1S 207145
Symproic® naldemedine Shionogi opioid-induced constipation (OIC) 2017/03/23 56:92 - GI Drugs, Miscellaneous 1S 208854
Bavencio® avelumab EMD Serono metastatic Merkel cell carcinoma (MCC) 2017/03/23 10:00 - Antineoplastic Agents 761049
Zejula® niraparib Tesaro epithelial ovarian, fallopian tube, or primary peritoneal cancer 2017/03/27 10:00 - Antineoplastic Agents 1P 208447
Dupixent® dupilumab Regeneron moderate-to-severe eczema (atopic dermatitis) 2017/03/28 84:92 - Skin and Mucous Membrane Agents, Misc 1 761055
Ocrevus® ocrelizumab Genentech relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS) 2017/03/28 92:20 - Immunomodulatory Agents 1 761053
Odactra® house dust mites (HDM) allergen extract MSD HDM-induced allergic rhinitis 2017/03/01 80:02 - Allergenic Extracts 125592
Austedo® deutetrabenazine Teva Huntington's chorea 2017/04/03 28:92 - Central Nervous System Agents, Misc 1S 208082
Ingrezza® valbenazine Neurocrine Biosciences tardive dyskinesia 2017/04/11 28:92 - Central Nervous System Agents, Misc 1P 209241
Roxybond® oxycodone Inspirion pain 2017/04/20 28:08.08 - Opiate Agonists 5P 209777
Renflexis® infliximab-abda Samsung Bioepsis Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis 2017/04/21 92:36 - Disease-modifying Antirheumatic Drugs 761054
Xatmep® methotrexate Silvergate acute lymphoblastic leukemia (ALL) in pediatric patients; active polyarticular juvenile idiopathic arthritis (pJIA) 2017/04/25 10:00 - Antineoplastic Agents 3S 208400
Brineura® cerliponase alfa Biomarin indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. 2017/04/27 44:00 - Enzymes 761052
Rydapt® midostaurin Novartis acute myeloid leukemia (AML) that is FLT3 mutation-positive; aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia 2017/04/28 10:00 - Antineoplastic Agents 1P 207997
Tymlos® abaloparatide Radius postmenopausal women with osteoporosis at high risk for fracture 2017/04/28 68:24 - Parathyroid 1/4S 208743
Alunbrig® brigatinib Ariad anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) 2017/04/28 10:00 - Antineoplastic Agents 1P 208772
Imfinzi® durvalumab AstraZeneca locally advanced or metastatic urothelial carcinoma 2017/05/01 10:00 - Antineoplastic Agents 761069
Steritalc® talc Novatech decrease the recurrence of malignant pleural effusions and pneumothorax 2017/05/01 24:16 - Sclerosing Agents 5S 205555
Kisqali® Femara® Co-Pack letrozole; ribociclib Novartis hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer 2017/05/04 10:00 - Antineoplastic Agents 4S 209935
Radicava® edaravone MT Pharma amyotrophic lateral sclerosis (ALS) 2017/05/05 28:92 - Central Nervous System Agents, Miscellaneous 1 209176
Minolira® minocycline hydrochloride Dr Reddy's moderate to severe acne vulgaris 2017/05/08 84:92 - Skin and Mucous Membrane Agents, Misc 5S 209269
Jadenu® deferasirox Novartis chronic iron overload 2017/05/08 64:00 - Heavy Metal Antagonists 5S 207968
Kevzara® sarilumab Sanofi adult rheumatoid arthritis 2017/05/23 92:36 - Disease-modifying Antirheumatic Drugs 1 761037
Zerviate® cetirizine hydrochloride Nicox ocular itching associated with allergic conjunctivitis 2017/05/30 52:02 - Antiallergic Agents 3P 208694
Rebinyn® factor IX (recombinant), glycoPEGylated
[nonacog beta pegol]
Novo Nordisk hemophilia B for on-demand treatment and control of bleeding episodes and for perioperative management of bleeding 2017/05/31 20:28.16 - Hemostatics 1 125611
Gleolan® aminolevulinic acid oral solution NX optical imaging 2017/06/06 3P 208630
Fibryna® fibrinogen (human) Octapharma afibrinogenemia and hypofibrinogenemia 2017/06/07 20:28.16 - Hemostatics 1 125612
Baxdela® delafloxacin Melinta acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria 2017/06/19 8:12.18 - Quinolones 1S 208610
Haegarda® C1 esterase inhibitor (human) CSL Behring prophylaxis of hereditary angioedema (HAE) 2017/06/22 92:32 - Complement Inhibitors 1O 125606
Bevyxxa® betrixaban Portola prophylaxis of venous thromboembolism (VTE) 2017/06/23 20:12.04.14 - Direct Factor Xa Inhibitors 1S 208383

Drug Classification Changes

 

AHFS Class Change Date Change Description
     

Drug Reassignments

 

Drug Name(s) Active Ingred Change
Date
Old AHFS Class New AHFS Class
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