| 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 |
