FDA Novel Drug Approvals 1999-2019 Metadata
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YearBrandBLA/ NDAFDA numberURL, Drugs at FDAclinital trials snapshot linkenrollment (according to snapshot)number of clinical trials (according to snapshot)clinical trial (according to snapshot)INNFDA Approval dateDate of EMA approval (D/M/Y form)FDA Review ClassORIGNDA Chem TypeWHO ATC CodeOrphan for initial approved indicationDesignation Date for initial orphan indicationBreakthrough* (Designation began 2013)FastrackPRVIndicationShort indicationCancerOriginal applicantCompanyOriginal label URL
2
2020STEMLINE THERAPEEUTICS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf
3
2019UbrelvyNDA211765https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211765https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ubrelvy24232NCT02828020, NCT02867709ubrogepantDec 23, 2019STANDARDto treat acute treatment of migraine with or without aura in adultsmigraine
4
2019EnhertuBLA761139https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761139https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-enhertu2342NCT03248492, NCT02564900fam-trastuzumab deruxtecan-nxkiDec 20, 2019PRIORITYn/aTo treat metastatic breast cancercancercancer
5
2019DayvigoNDA212028https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212028https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-dayvigo16922NCT02952820, NCT02783729lemborexantDec 20, 2019STANDARDTo treat insomniainsomnia
6
2019CaplytaNDA209500https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209500https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-caplyta8183
NCT01499563, NCT02282761, NCT02469155
lumateperone tosylateDec 20, 2019STANDARDTo treat schizophreniamental health
7
2019TissueBlueNDA209569https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209569https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tissueblue---Brilliant Blue G Ophthalmic SolutionDec 20, 2019PRIORITYorphanDye used in eye surgeryeye surgeryDUTCH OPHTHALMIC
8
2019PadcevBLA761137https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761137https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-padcev1251NCT03219333enfortumab vedotin-ejfvDec 18, 2019PRIORITYn/aTo treat refractory bladder cancercancercancerAstellas
9
2019Vyondys 53NDA211970https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211970https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyondys-53622NCT02310906, NCT0250381golodirsenDec 12, 2019PRIORITYorphanTo treat certain patients with Duchenne muscular dystrophy
Duchenne muscular dystrophy
SAREPTA THERAPS INC
10
2019OxbrytaNDA213137https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213137https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-oxbryta1821NCT03036813voxelotorNov 25, 2019PRIORITYorphanTo treat sickle cell diseasesickle cell diseaseGLOBAL BLOOD THERAPS
11
2019XcopriNDA212839https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212839https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xcopri6552NCT01866111, NCT01397968cenobamateNov 21, 2019STANDARDTo treat partial onset seizuresseizures
12
2019GivlaariNDA212194https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212194https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-givlaari941NCT03338816givosiranNov 20, 2019PRIORITYorphanTo treat acute hepatic porphyria, a rare blood disorder
acute hepatic porphyria
ALNYLAM PHARMS INC
13
2019AdakveoBLA761128https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761128https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo1321NCT01895361crizanlizumab-tmcaNov 15, 2019PRIORITYorphanTo treat patients with painful complication of sickle cell diseasesickle cell diseaseNOVARTIS PHARMS CORP
14
2019FetrojaNDA209445https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209445https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-fetroja4481NCT02321800cefiderocolNov 14, 2019PRIORITYTo treat patients with complicated urinary tract infections who have limited or no alternative treatment optionsurinary tract infections
15
2019BrukinsaNDA213217https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213217https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-brukinsa1182NCT03206970, NCT 02343120zanubrutinibNov 14, 2019PRIORITYorphanTo treat certain patients with mantle cell lymphoma, a form of blood cancercancercancerBEIGENE
16
2019ReblozylBLA761136https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761136https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-reblozyl3361NCT02604433luspatercept–aamtNov 8, 2019PRIORITYorphanFor the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusionsanemiaCELGENE CORP
17
2019ExEm FoamNDA212279https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212279https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-exem-foam1822
"Trial A from the article by Riganelli et al. 2018* and Trial B by from the article by Ludwin et al. 2017**"
air polymer-type ANov 7, 2019STANDARDA diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility
diagnosis for fallopian tube patency
18
2019TrikaftaNDA212273https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212273https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-trikafta5102NCT03525444, NCT03525548elexacaftor/ivacaftor/tezacaftorOct 21, 2019PRIORITYorphanTo treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosiscystic fibrosisVERTEX PHARMS INC
19
2019ReyvowNDA211280https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211280https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-reyvow44392NCT02439320, NCT02605174lasmiditanOct 11, 2019STANDARDFor the acute treatment of migraine with or without aura, in adultsmigraineEli Lilly
20
2019
FLUORODOPA F18
200655https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200655https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-fluorodopa-f-18561-fluorodopa F 18Oct 10, 2019STANDARDA diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS)Parkinson's
21
2019ScenesseNDA210797https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210797https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-scenesse2443
NCT 01605136, NCT00979745, NCT01097044
afamelanotideOct 8, 2019PRIORITYorphanTo increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyriaSkin diseaseCLIVUNEL INC
22
2019BeovuBLA761125https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761125https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-beovu14592NCT02307682, NCT02434328brolucizumab–dbllOct 7, 2019PRIORITYTreatment of wet age-related macular degenerationvisionNOVARTIS PHARMS CORP
23
2019AkliefNDA211527https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211527https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-aklief24202NCT02566369, NCT02556788trifaroteneOct 4, 2019STANDARDFor the topical treatment of acne vulgaris in patients 9 years of age and olderSkin diseaseGALDERMA R AND D
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2019IbsrelaNDA211801https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211801https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ibsrela11992NCT02686138, NCT02621892tenapanorSep 12, 2019STANDARDTo treat irritable bowel syndrome with constipation in adults.
irritable bowel syndrome
ARDELYX INC
25
2019NourianzNDA22075https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=22075https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-nourianz11604
NCT00456586, NCT00199407, NCT00455507, NCT00955526
istradefyllineAug 27, 2019STANDARDTo treat adult patients with Parkinson’s disease experiencing “off” episodesParkinson'sKYOWA KIRIN
26
2019
GALLIUM DOTATOC GA 68
NDA210828https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210828https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ga-68-dotatoc3343NCT1619865, NCT1869725, NCT2441062Ga-68-DOTATOCAug 21, 2019PRIORITYorphanFor use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)DiagnosticUIHC PET IMAGING
27
2019XenletaNDA
211672, 211673
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211672https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xenleta12892NCT02559310, NCT02813694lefamulinAug 19, 2019PRIORITYTo treat adults with community-acquired bacterial pneumoniapneumonia
28
2019RinvoqNDA211675https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211675https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rinvoq31415
NCT02706873, NCT02706951, NCT02675426, NCT02629159, NCT02706847
upadacitinibAug 16, 2019PRIORITYTo treat adults with moderately to severely active rheumatoid arthritisRAABBVIE INC
29
2019InrebicNDA212327https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212327https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-inrebic1921NCT01437787fedratinibAug 16, 2019PRIORITYorphanTo treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosiscancercancerIMPACT
30
2019RozlytrekNDA
212725, 212726
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212725
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rozlytrek
3554
EudraCT 2012-000148-88, NCT02097810, NCT02568267, NCT02650401
entrectinibAug 15, 2019PRIORITYorphanTo treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive; To treat adult and pediatric patients 12 years of age and older with solid tumorscancercancerGENENTECH INC
31
2019WakixNDA211150https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211150https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-wakix2663
NCT01067222, NCT01638403, NCT01800045
pitolisantAug 14, 2019PRIORITYorphanTo treat excessive daytime sleepiness (EDS) in adult patients with narcolepsyexcessive sleepinessHARMONY
32
2019PRETOMANIDNDA212862https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212862https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-pretomanid1091NCT02333799pretomanidAug 14, 2019PRIORITYorphanFor treatment-resistant forms of tuberculosis that affects the lungsTBMYLAN IRELAND LTD
33
2019TuralioNDA211810https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211810https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-turalio1201NCT02371369pexidartinibAug 2, 2019PRIORITYorphanTo treat adult patients with symptomatic tenosynovial giant cell tumorcancercancerDAIICHI SANKYO INC
34
2019NubeqaNDA212099https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212099https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-nubeqa15091NCT02200614darolutamideJul 30, 2019PRIORITYTo treat adult patients with non-metastatic castration resistant prostate cancercancercancerBAYER HEALTHCARE
35
2019AccruferNDA212320https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212320https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-accrufer2953
NCT01252221, NCT01340872, NCT02968368
ferric maltolJul 25, 2019STANDARDTo treat iron deficiency anemia in adultsanemiaSHIELD TX
36
2019RecarbrioNDA212819https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212819https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trial-snapshot-recarbrio4302NCT01505634, NCT01506271
imipenem, cilastatin and relebactam
Jul 16, 2019PRIORITYTo treat complicated urinary tract and complicated intra-abdominal infections
urinary tract and intra-abdominal infections
MSD MERCK CO
37
2019XpovioNDA212306https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212306https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xpovio2021NCT02336815selinexorJul 3, 2019PRIORITYorphanTo treat adult patients with relapsed or refractory multiple myeloma (RRMM)cancercancerKARYOPHARM THERAPS
38
2019VyleesiNDA210557https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210557https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyleesi12672NCT02333071, NCT02338960bremelanotideJun 21, 2018STANDARDTo treat hypoactive sexual desire disorder in premenopausal women.sexual healthAMAG PHARMS INC
39
2019PolivyBLA761121https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761121https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-polivy801NCT02257567polatuzumab vedotin-piiqJun 10, 2019PRIORITYorphanTo treat adult patients with relapsed or refractory diffuse large B-cell lymphomacancercancerGENENTECH INC
40
2019PiqrayNDA212526https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212526https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-piqray5711NCT02437318alpelisibMay 24, 2019PRIORITYTo treat breast cancercancercancerNOVARTIS
41
2019VyndaqelNDA211996https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211996https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trial-snapshots-vyndaqelvyndamax4411NCT01994889tafamidis meglumineMay 3, 2019PRIORITYorphanTo treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adultsheart diseaseFOLDRX PHARMS
42
2019SkyriziBLA761105https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761105https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-skyrizi16065
NCT0202684370, NCT02684357, NCT02672852, NCT02694523, NCT02054481
risankizumab-rzaaApr 23, 2019STANDARDTo treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapypsoriasisABBVIE
43
2019BalversaNDA212018https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212018https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-balversa871NCT02365597erdafitinibApr 12, 2019PRIORITYTo treat adult patients with locally advanced or metastatic bladder cancercancercancerJANSSEN BIOTECH
44
2019EvenityBLA761062https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761062https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-evenity112732-romosozumab-aqqgApr 9, 2019STANDARDTo treat osteoporosis in postmenopausal women at high risk of fractureosteoporosisAMGEN
45
2019MayzentNDA209884https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209884https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-mayzent16511NCT01665144siponimodMar 26, 2019PRIORITYTo treat adults with relapsing forms of multiple sclerosismultiple sclerosisNORVARTIS
46
2019SunosiNDA211230https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211230https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-sunosi6225
NCT02348593, NCT02348606, NCT02348619, NCT02348632, NCT01681121
solriamfetolMar 20, 2019STANDARDorphanTo treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apneaexcessive sleepinessJAZZ
47
2019ZulressoNDA211371https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211371https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-zulresso2473
NCT02942004, NCT02614541, NCT02942017
brexanoloneMar 19, 2019PRIORITYTo treat postpartum depression (PPD) in adult womenmental healthSAGE THERAP
48
2019EgatenNDA208711https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208711https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-egaten4669-triclabendazoleFeb 13, 2019PRIORITYorphanTo treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes”fascioliasisNOVARTIS
49
2019CabliviBLA761112https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761112---caplacizumab-yhdpFeb 6, 2019PRIORITYorphanTo treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)Blood disorderABLYNX NV
50
2019JeuveauBLA761085https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761085https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-jeuveau6542NCT02334423, NCT02334436prabotulinumtoxinA-xvfsFeb 1, 2019STANDARDFor the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patientsglabellar linesEVOLUS
51
52
2018ElzonrisBLA761116https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-elzonris941NCT02113982tagraxofusp-erzs2018-Dec-21PRIORITYORIG-1ORPHAN06/06/2013Yes
To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Stemline TherapeuticsSTEMLINE THERAPEEUTICS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf
53
2018UltomirisBLA761108https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ultomiris4412NCT02946463, NCT03056040ravulizumab2018-Dec-21PRIORITYORIG-1ORPHAN01/04/2017
To treat paroxysmal nocturnal hemoglobinuria (PNH)
paroxysmal nocturnal hemoglobinuria (PNH)
Alexion PharmaceuticalsALEXION PHARM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf
54
2018AsparlasBLA761102https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-asparlas2372NCT01574274, AALL07P4calaspargase pegol-mknl2018-Dec-20STANDARDORIG-1ORPHAN10/25/17
To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years
acute lymphoblastic leukemia (ALL)
CancerServier PharmaceuticalsSERVIER PHARMA LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf
55
2018MotegrityNDA210166https://www.fda.gov/drugs/drug-trials-snapshots-motegrity2,4846NCT01116206, NCT01147926, NCT00488137, NCT00483886, NCT00485940, NCT01424228prucalopride2018-Dec-14STANDARDORIG-11
To treat chronic idiopathic constipation
chronic idiopathic constipation
Shire DevelopmentSHIRE DEV LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf
56
2018FirdapseNDA208078https://www.fda.gov/drugs/drug-trial-snapshot-firdapse642NCT01377922, NCT02970162amifampridine2018-Nov-2823/12/2009PRIORITYORIG-11ORPHAN11/12/2009Yes
To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults
Lambert-Eaton myasthenic syndrome (LEMS)
Catalyst PharmaceuticalsCATALYST PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf
57
2018XospataNDA211349https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trial-snapshot-xospata2923NAgilteritinib2018-Nov-28PRIORITYORIG-11ORPHAN07/13/2017Yes
To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
acute myeloid leukemia (AML)
CancerAstellas Pharma USASTELLAS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211349s000lbl.pdf
58
2018VitrakviNDA210861https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vitrakvi1763NCT02122913, NCT02637687, NCT02576431larotrectinib2018-Nov-26PRIORITYORIG-11ORPHAN05/09/2017Yes
To treat patients whose cancers have a specific genetic feature (biomarker)
cancers have a specific genetic feature (biomarker)
CancerLoxo OncologyLOXO ONCOLOGY INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf
59
2018DaurismoNDA210656https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-daurismo1251NCT01546038glasdegib2018-Nov-21PRIORITYORIG-11ORPHAN06/28/2017
To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients
acute myeloid leukemia (AML)
CancerPfizerPFIZER INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf
60
2018GamifantBLA761107https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-gamifant341NCT01818492emapalumab-lzsg2018-Nov-20PRIORITYORIG-1ORPHAN03/26/2010YesYes
To treat primary hemophagocytic lymphohistiocytosis (HLH)
primary hemophagocytic lymphohistiocytosis (HLH)
Novimmune S.A.NOVIMMUNE S.A.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761107s000lbl.pdf
61
2018AemcoloNDA210910https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-aemcolo1,0992NCT01142089, NCT01208922rifamycin2018-Nov-16PRIORITYORIG-11YesTo treat travelers’ diarrheatravelers’ diarrheaCosmo TechnologiesCOSMO TECHNOLOGIES
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210910s000lbl.pdf
62
2018YupelriNDA210598https://www.fda.gov/drugs/drug-trials-snapshots-yupelri8132NCT02459080, NCT02512510revefenacin2018-Nov-08STANDARDORIG-11
To treat patients with chronic obstructive pulmonary disease (COPD)
chronic obstructive pulmonary disease (COPD)
Theravance BiopharmaMYLAN IRELAND LTD
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210598s000lbl.pdf
63
2018LorbrenaNDA210868https://www.fda.gov/drugs/drug-trials-snapshots-lorbrena2951NCT01970865lorlatinib2018-Nov-02PRIORITYORIG-11ORPHAN06/23/2015Yes
To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
CancerPfizerPFIZER INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf
64
2018XofluzaNDA210854NANANAbaloxavir marboxil2018-Oct-24PRIORITYORIG-11
For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
influenzaShionogiGENENTECH INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf
65
2018TalzennaNDA211651NANANAtalazoparib2018-Oct-16PRIORITYORIG-11
For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
breast cancerCancerPfizerPFIZER INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
66
2018RevcoviBLA761092NANANAelapegademase-lvlr2018-Oct-05PRIORITYORIG-1ORPHAN03/19/2015YesYes
To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
Leadiant BiosciencesLEADIANT BIOSCI INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761092s000lbl.pdf
67
2018TegsediNDA211172NANANAinotersen2018-Oct-0505/07/2018PRIORITYORIG-11ORPHAN07/24/2012Yes
To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
transthyretin-mediated amyloidosis
Ionis PharmaceuticalsAKCEA THERAPS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf
68
2018NuzyraNDA209816https://www.fda.gov/drugs/drug-trials-snapshots-nuzyra7741NCT02531438omadacycline2018-Oct-03PRIORITYORIG-11Yes
To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
bacterial pneumonia and acute bacterial skin and skin structure infections
Paratek PharmaceuticalsPARATEK PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf
69
2018SeysaraNDA209521https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-seysara2,1333NCT02320149, NCT02322866, NCT01628549sarecycline2018-Oct-01STANDARDORIG-11
To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
acne vulgarisAllerganALMIRALL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf
70
2018LibtayoBLA761107https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-libtayo1632NCT02383212, NCT02760498cemiplimab-rwlc2018-Sep-28PRIORITYORIG-1Yes
To treat cutaneous squamous cell carcinoma (CSCC)
cutaneous squamous cell carcinoma
CancerRegeneron PharmaceuticalsREGENERON PHARMACEUTICALS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf
71
2018EmgalityBLA761063https://www.fda.gov/drugs/drug-trials-snapshots-emgality2,1563NCT02614183, NCT02614196, NCT02614261galcanezumab-gnlm2018-Sep-2714/11/2018STANDARDORIG-1
For the preventive treatment of migraine in adults
migraineEli Lilly and CompanyELI LILLY AND CO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf
72
2018VizimproNDA211288https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-vizimpro4521NCT01774721dacomitinib2018-Sep-27PRIORITYORIG-11, 4ORPHAN03/03/2015
To treat metastatic non-small-cell lung cancer
non-small-cell lung cancer
CancerPfizerPFIZER INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf
73
2018CopiktraNDA211155https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-copiktra4424NCT02004522, NCT02204982, NCT01476657, NCT02049515duvelisib2018-Sep-24PRIORITY
ORIG-1, ORIG-2
1, efficacyORPHAN04/15/2013Yes
To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
chronic lymphocytic leukemia
CancerVerastemVERASTEM INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211155s000lbl.pdf
74
2018AjovyBLA761089https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-ajovy1,9862NCT02629861, NCT02621931fremanezumab-vfrm2018-Sep-14PRIORITYORIG-1
For the preventive treatment of migraine in adults
migraineTeva Pharmaceuticals USATEVA PHARMS USA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf
75
2018LumoxitiBLA761104https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-lumoxiti801NCT 01829711moxetumomab pasudotox-tdfk2018-Sep-13PRIORITYORIG-1ORPHAN11/15/2007YesTo treat hairy cell leukemiahairy cell leukemiaCancerAstraZeneca ABASTRAZENECA AB
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf
76
2018PifeltroNDA210806https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-pifeltro1,4942NCT02275780, NCT02403674doravirine2018-Aug-3022/11/2018STANDARDORIG-11
To treat HIV-1 infection in adult patients
HIV-1Merck Sharp & Dohme CorporationMSD MERCK CO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210806s000lbl.pdf
77
2018XeravaNDA211109https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-xerava1,0372NCT01844856, NCT02784704eravacycline2018-Aug-2720/09/2018PRIORITYORIG-11Yes
To treat complicated intra-abdominal infections in patients 18 years of age and older
complicated intra-abdominal infections
Tetraphase PharmaceuticalsTETRAPHASE PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf
78
2018TakhzyroBLA761090https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-takhzyro1251NCT02586805lanadelumab2018-Aug-2322/11/2018PRIORITYORIG-1ORPHAN11/26/2013YesYes
To treat types I and II hereditary angioedema
angioedemaDyax CorpDYAX CORP.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s000lbl.pdf
79
2018OxervateBLA761094https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-oxervate1512NAcenegermin-bkbj2018-Aug-2206/07/2017PRIORITYORIG-1ORPHAN06/23/2014YesYesTo treat neurotrophic keratitisneurotrophic keratitisDompé farmaceuticiDOMPE FARMACEUTICI
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf
80
2018DiacomitNDA206709https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-diacomit642NAstiripentol2018-Aug-2003/01/2007PRIORITYORIG-11ORPHAN10/30/2008
To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
seizures associated with Dravet syndrome
BiocodexBIOCODEX SA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf
81
2018AnnoveraNDA209627https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-annovera2,3083NCT0455156, NCT00263342, Trial 3/300PK
segesterone acetate and ethinyl estradiol vaginal system
2018-Aug-10STANDARDORIG-11
New vaginal ring used to prevent pregnancy for an entire year
birth controlThe Population CouncilTHERAPEUTICSMD INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209627s000lbl.pdf
82
2018GalafoldNDA208623https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-galafold671NCT00925301migalastat2018-Aug-1025/05/2016PRIORITYORIG-11ORPHAN02/25/2004Yes
To treat treat adults with Fabry disease.
Fabry diseaseAmicus Therapeutics U.S.AMICUS THERAPS US
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf
83
2018OnpattroNDA210922https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-onpattro2251NCT01960348patisiran2018-Aug-1027/08/2018PRIORITYORIG-11ORPHAN06/14/2012YesYes
To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
amyloidosisAlnylam PharmaceuticalsALNYLAM PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf
84
2018PoteligeoBLA761051https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-poteligeo3721NCT01728805mogamulizumab-kpkc2018-Aug-0822/11/2018PRIORITYORIG-1ORPHAN11/02/2010Yes
To treat two rare types of non-Hodgkin lymphoma
non-Hodgkin lymphoma
CancerKyowa KirinKYOWA KIRIN
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf
85
2018MulpletaNDA210923https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-mulpleta3413NAlusutrombopag2018-Jul-31PRIORITYORIG-11Yes
To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
thrombocytopeniaShionogiSHIONOGI INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210923s000lbl.pdf
86
2018OmegavenNDA210589https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-omegaven1892NCT00910104, NCT00738101fish oil triglycerides2018-Jul-27PRIORITYORIG-11, 4ORPHAN02/27/2008Yes
As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
nutrition-associated cholestasis
Fresenius Kabi USAFRESENIUS KABI USA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/0210589s000lbledt.pdf
87
2018OrilissaNDA210450https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-orilissa1,6862NCT01620528, NCT01931670elagolix sodium2018-Jul-23PRIORITYORIG-11
For the management of moderate to severe pain associated with endometriosis
pain associated with endometriosis
AbbVieABBVIE INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210450s000lbl.pdf
88
2018KrintafelNDA210795https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-krintafel5221NCT01376167tafenoquine2018-Jul-20PRIORITYORIG-11ORPHAN01/15/2013Yes
For the radical cure (prevention of relapse) of Plasmodium vivax malaria
Plasmodium vivax malaria
GlaxoSmithKlineGLAXOSMITHKLINE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210795s000lbl.pdf
89
2018TibsovoNDA211192https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tibsovo1791NCT02074839ivosidenib2018-Jul-20PRIORITYORIG-11ORPHAN06/09/2015Yes
To treat patients with relapsed or refractory acute myeloid leukemia
myeloid leukemiaCancerAgios PharmaceuticalsAGIOS PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf
90
2018TPOXXNDA208627https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-tpoxx4491NAtecovirimat2018-Jul-13PRIORITYORIG-11ORPHAN12/27/2006YesTo treat smallpoxsmallpoxSIGA TechnologiesSIGA TECHNOLOGIES
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf
91
2018BraftoviNDA210496https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-braftovi3831NCT01909453encorafenib2018-Jun-2719/09/2018STANDARDORIG-11, 4, efficacyORPHAN11/19/2013
To treat unresectable or metastatic melanoma
melanomaCancerArray BioPharmaARRAY BIOPHARMA INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf
92
2018MektoviNDA210498https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-mektovi3831NCT01909453binimetinib2018-Jun-2720/09/2018STANDARDORIG-11, 4, efficacyORPHAN11/19/2013
To treat unresectable or metastatic melanoma
melanomaCancerArray BioPharmaARRAY BIOPHARMA INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf
93
2018EpidiolexNDA210365https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-epidiolex5504NCT02224560, NCT02224690, NCT02091375, NCT02091375cannabidiol2018-Jun-25PRIORITYORIG-11ORPHAN11/14/2013YesYes
To treat rare, severe forms of epilepsy
epilepsyGW ResearchGW RES LTD
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
94
2018ZemdriNDA210303https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-zemdri6041NCT02486627plazomicin2018-Jun-25PRIORITYORIG-11
To treat adults with complicated urinary tract infections
urinary tract infectionsAchaogenACHAOGEN INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303Orig1s000lbl.pdf
95
2018MoxidectinNDA210867https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-moxidectin1,4721NCT00790998moxidectin2018-Jun-13PRIORITYORIG-11ORPHAN09/29/2010
To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
onchocerciasisMedicines DevelopmentMDGH
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210867lbl.pdf
96
2018OlumiantNDA207924https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-olumiant2,4564NCT01711359, NCT01710358, NCT01721057, NCT01721044baricitinib2018-May-3113/02/2017STANDARDORIG-11
To treat moderately to severely active rheumatoid arthritis
rheumatoid arthritisEli Lilly and CompanyELI LILLY AND CO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924Orig1s000lbl.pdf
97
2018PalynziqNDA761079https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-palynziq2852NCT01819727, NCT01889862pegvaliase-pqpz2018-May-24PRIORITYORIG-1N/AORPHAN03/08/1995Yes
To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)
phenylketonuriaBioMarin PharmaceuticalBIOMARIN PHARM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf
98
2018DopteletNDA210238https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-doptelet4352NCT01972529, 01976104avatrombopag2018-May-21PRIORITYORIG-11ORPHAN
To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure
thrombocytopeniaAkaRxAKARX INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210238s000lbl.pdf
99
2018LokelmaNDA207078https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-lokelma1,0112NCT01737697, NCT02088073sodium zirconium cyclosilicate2018-May-1822/03/2018STANDARDORIG-11To treat hyperkalemiahyperkalemiaAstraZeneca PharmaceuticalsASTRAZENECA PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207078s000lbl.pdf
100
2018AimovigBLA761077https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-aimovig2,1843NCT02456740, NCT02483585, NCT02066415erenumab-aooe2018-May-1726/07/2018STANDARDORIG-1
For the preventive treatment for migraine
migraineAmgenAMGEN INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf
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