New Molecular Entities

    Basic Details
    Date Posted
    Wednesday, October 4, 2017
    Status
    In progress
    Medical Product
    abiraterone acetate
    aclidinium bromide
    ado-trastuzumab emtansine
    afatinib dimaleate
    albiglutide
    alcaftadine
    alectinib HCL
    alglucosidase alfa
    alirocumab
    alogliptin benzoate
    apixaban
    apremilast
    aripiprazole
    aripiprazole lauroxil
    asfotase alfa
    asparaginase
    avanafil
    axitinib
    azilsartan medoxomil
    bazedoxifene
    bedaquiline fumarate
    belatacept
    belimumab
    belinostat
    blinatumomab
    boceprevir
    bosutinib
    brexpiprazole
    cabazitaxel
    cabozantinib
    canagliflozin
    cangrelor tetrasodium
    carfilzomib
    carglumic acid
    cariprazine HCL
    ceftaroline fosamil acetate
    ceftazidime/avibactam
    ceftolozane
    ceritinib
    cholic acid
    clobazam
    cobicistat
    cobimetinib fumarate
    collagenase clostridium histolyticum
    crofelemer
    dabigatran etexilate mesylate
    dabrafenib mesylate
    daclatasvir dihydrochloride
    dalbavancin HCL
    dalfampridine
    dapagliflozin propanediol
    daratumumab
    deferiprone
    denosumab
    deoxycholic acid
    dimethyl fumarate
    dinutuximab
    dolutegravir sodium
    droxidopa
    dulaglutide
    edoxaban tosylate
    efinaconazole
    eliglustat tartrate
    elosulfase alfa
    elotuzumab
    eluxadoline
    elvitegravir
    elvitegravir/cobicistat/emtricitabine/tenofovir
    empagliflozin
    enzalutamide
    eribulin mesylate
    eslicarbazepine acetate
    estradiol valerate/dienogest
    estrogen
    evolocumab
    ezogabine
    fidaxomicin
    fingolimod HCL
    flibanserin
    florbetapir f-18
    fluconazole
    flutemetamol f-18
    gabapentin enacarbil
    gadobutrol
    gadoterate meglumine
    glucarpidase
    ibrutinib
    icatibant acetate
    idarucizumab
    idelalisib
    incobotulinumtoxina
    indacterol maleate
    ingenol mebutate
    insulin degludec
    ioflupane i-123
    ipilimumab
    isavuconazonium sulfate
    ivabradine HCL
    ivacaftor
    ixazomib citrate
    ledipasvir
    lenvatinib mesylate
    linaclotide
    linagliptin
    liraglutide
    lomitapide mesylate
    lorcaserin HCl
    lucinactant
    luliconazole
    lumacaftor/ivacaftor
    lurasidone HCL
    macitentan
    mepolizumab
    metreleptin
    miltefosine
    mipomersen sodium
    naloxegol oxalate
    necitumumab
    netupitant
    nintedanib esylate
    nivolumab
    obinutuzumab
    ocriplasmin
    olaparib
    olodaterol HCL
    omacetaxine mepesuccinate
    ombitasvir
    oritavancin diphosphate
    osimertinib mesylate
    ospemifene
    palbociclib
    palonosetron HCL
    panobinostat lactate
    parathyroid hormone
    paritaprevir
    pasireotide diaspartate
    patiromer calcium sorbitex
    peginterferon beta-1a
    pegloticase
    pembrolizumab
    peramivir
    pirfenidone
    pitavastatin
    polidocanol
    pomalidomide
    radium-223 dichloride
    ramucirumab
    rilpivirine HCL
    riociguat
    rivaroxaban
    roflumilast
    rolapitant HCL
    ruxolitinib phosphate
    sacubitril/valsartan
    sebelipase alfa
    secukinumab
    selexipag
    siltuximab
    simeprevir sodium
    sofosbuvir
    sonidegib phosphate
    spinosad
    sugammadex sodium
    sulfur hexafluoride microsphere
    suvorexant
    tasimelteon
    tazobactam
    tedizolid phosphate
    teduglutide
    telaprevir
    tenofovir disoproxil fumarate
    teriflunomide
    tesamorelin acetate
    ticagrelor
    tocilizumab
    tofacitinib citrate
    trabectedin
    trametinib dimethyl sulfoxide
    trifluridine/tipiracil HCL
    ulipristal acetate
    umeclidinium
    uridine
    vandetanib
    vedolizumab
    velaglucerase alfa
    vemurafenib
    vilanterol
    vilazodone HCL
    vismodegib
    vorapaxar sulfate
    vortioxetine hydrobromide
    ziv-aflibercept
    Description

    Summary table assessment of the use of new molecular entities (NMEs) approved in the Sentinel Distributed Database. NMEs were identified by generic names and Healthcare Common Procedure Coding System (HCPCS) codes. Results were generated using the Sentinel Distributed Query Tool. The queries were run against the Dispensing Summary Table and the HCPCS Summary Table. 

    NMEs Approved in 2015

    NMEs Approved in 2014

    NMEs Approved in 2013

    NMEs Approved in 2012

    NMEs Approved in 2011

    NMEs Approved in 2010

    Additional Details
    FDA Center
    CDER
    Study Type
    Summary Table
    Assessment Type
    Exploratory Analyses
    Data Sources
    Sentinel Distributed Database (SDD)