New Molecular Entities

Project Title New Molecular Entities
Date Posted
Wednesday, October 4, 2017
Status
In progress
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

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