. 2020 Jul 24;3(7):e209498. doi: 10.1001/jamanetworkopen.2020.9498

Table 1. Novel Therapeutic Agents Approved 2011-2015.

Year, agent
2011 (n = 29)
Aflibercept^a Asparaginase erwinia chrysanthemi Ruxolitinib phosphate Clobazam Deferiprone Crizotinib Icatibant acetate^b^,^c Brentuximab vedotin Vemurafenib	Ticagrelor^b Indacaterol maleate Rivaroxaban Belatacept Ezogabine Fidaxomicin Telaprevir Rilpivirine hydrochloride Boceprevir Linagliptin	Abiraterone acetate Gabapentin enacarbil Vandetanib Ipilimumab Belimumab Roflumilast Azilsartan kamedoxomil^a Vilazodone hydrochloride^c Spinosad
2012 (n = 36)
Crofelemerb^b Apixaban^c Bedaquiline fumarate Lomitapide mesylate Teduglutide recombinant Pasireotide diaspartate^a Ponatinib hydrochloride Raxibacumab Cabozantinib s-malate Tofacitinib citrate Omacetaxine mepesuccinate^c Perampanel^c^,^d	Ocriplasmin Regorafenib Teriflunomide^a^,^c Bosutinib monohydrate^a^,^c^,^d Enzalutamide Linaclotide^a^,^c^,^d Tbo-filgrastim Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate Ziv-aflibercept Aclidinium bromide Carfilzomib	Mirabegron Lorcaserin hydrochloride Pertuzumab^b Taliglucerase alfa Avanafil Peginesatide acetate Lucinactant Tafluprost Ivacaftor Vismodegib^c Axitinib Ingenol mebutate Glucarpidase
2013 (n = 24)
Umeclidinium bromide; vilanterol trifenatate Sofosbuvir Simeprevir sodium Luliconazole Ibrutinib Eslicarbazepine acetate^b Obinutuzumab Macitentan Riociguat^a	Bazedoxifene acetate; estrogens, conjugated Vortioxetine hydrobromide Dolutegravir sodium Afatinib dimaleate Dabrafenib mesylate Trametinib dimethyl sulfoxide Radium Ra-223 dichloride	Fluticasone furoate; vilanterol trifenatate Canagliflozin^a^,^d Dimethyl fumarate^b Ospemifene Ado-trastuzumab emtansine Pomalidomide Mipomersen sodium Alogliptin benzoate^c
2014 (n = 38)
Nivolumab Ceftolozane sulfate; tazobactam sodium Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir Olaparib^a Peramivir Finafloxacin Blinatumomab Nintedanib esylate Pirfenidone Ledipasvir; sofosbuvir Netupitant; palonosetron hydrochloride	Dulaglutide^a Naloxegol oxalate Pembrolizumab Eliglustat tartrate Peginterferon beta-1a Suvorexant Oritavancin diphosphate Empagliflozin Olodaterol hydrochloride Idelalisib Tavaborole Belinostat Tedizolid phosphate Dalbavancin hydrochloride^a^,^b	Vedolizumab^d Vorapaxar sulfate^c Ceritinib Siltuximab Ramucirumab^c Albiglutide Apremilast^c Miltefosine^c Metreleptin Droxidopa^a^,^b Elosulfase alfa Tasimelteon Dapagliflozin
2015 (n = 48)
Lesinurad^b^,^c Selexipag^c Sugammadex sodium Alectinib hydrochloride Sebelipase alfa Elotuzumab Necitumumab Ixazomib citrate Daratumumab Osimertinib mesylate Cobimetinib fumarate Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate Mepolizumab^c^,^d Asfotase alfa Trabectedin Patiromer sorbitex calcium	Idarucizumab^c Aripiprazole lauroxil Insulin aspart; insulin degludec Insulin degludec Tipiracil hydrochloride; trifluridine Cariprazine hydrochloride Uridine triacetate Rolapitant hydrochloride Evolocumab Flibanserin^b Alirocumab^c^,^d Daclatasvir dihydrochloride Sonidegib phosphate Brexpiprazole Sacubitril; valsartan^a Ivacaftor; lumacaftor	Cangrelor^a^,^b Eluxadoline Olodaterol hydrochloride; tiotropium bromide Deoxycholic acid Ivabradine hydrochloride^a^,^d Cholic acid^d Dinutuximab Filgrastim-sndz Isavuconazonium sulfate Avibactam sodium; ceftazidime Panobinostat lactate^b Lenvatinib mesylate Palbociclib Parathyroid hormone Secukinumab^a^,^c Edoxaban tosylate^d

^{^a}

Denotes approval packages containing 1 or more disagreements pertaining to some other form of disagreement not mentioned in the subsequent footnotes.

^{^b}

Denotes approval packages containing 1 or more disagreements regarding approval.

^{^c}

Denotes approval packages containing 1 or more disagreements pertaining to parameters of approval.

^{^d}

Denotes approval packages containing 1 or more disagreements pertaining to population or indication.