Novel Drug Approvals 1999-2017 Metadata
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YearBrandINNBLA/NDAFDA numberFDA 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
2017Giaprezaangiotensin IINDA2093602017-Dec-21PRIORITYORIG-11
To increase blood pressure in adults with septic or other distributive shock
blood pressure
La Jolla Pharmaceutical Co
LA JOLLA PHARMACEUTICAL CO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209360s000lbl.pdf
3
2017Macrilen
macimorelin acetate
NDA2055982017-Dec-20STANDARDORIG-11ORPHAN5/14/2007
For the diagnosis of adult growth hormone deficiency
growth hormone difficiency (diagnosis)
Aeterna Zentaris GmBH
AETERNA ZENTARIS GMBH
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205598s000lbl.pdf
4
2017SteglatroertugliflozinNDA2098032017-Dec-19STANDARDORIG-11
To improve glycemic control in adults with type 2 diabetes mellitus
diabetes
Merck Sharp and Dohme Corp
MERCK SHARP DOHME
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf
5
2017RhopressanetarsudilNDA2082542017-Dec-18STANDARDORIG-11
To treat glaucoma or ocular hypertension
glaucoma
Aerie Pharmaceuticals Inc
AERIE PHARMACEUTICALS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf
6
2017XepiozenoxacinNDA2089452017-Dec-11STANDARDORIG-11To treat impetigoskin infection
Ferrer International SA
FERRER INTERNACIONAL S.A.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208945lbl.pdf
7
2017OzempicsemaglutideNDA2096372017-Dec-05STANDARDORIG-11
To improve glycemic control in adults with type 2 diabetes mellitus
diabetesNovo Nordisk IncNOVO NORDISK INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
8
2017HemlibraemicizumabBLA7610832017-Nov-16PRIORITYORIG-1ORPHAN1/10/2014Yes
To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
hemophiliaGenentech IncGENENTECH INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf
9
2017Mepsevii
vestronidase alfa-vjbk
BLA7610472017-Nov-15PRIORITYORIG-1ORPHAN2/16/2012YesYes
To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome.
Sly syndrome
Ultragenyx Pharmaceutical Inc
ULTRAGENYX PHARM INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761047s000lbl.pdf
10
2017FasenrabenralizumabBLA7610702017-Nov-14PRIORITYORIG-1
For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
asthmaAstraZeneca ABASTRAZENECA ABhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf
11
2017PrevymisletermovirNDA2099392017-Nov-08PRIORITYORIG-11ORPHAN12/12/2011YesYes
To prevent infection after bone marrow transplant
post-bone marrow transplant
Merck Sharp and Dohme Corp
MERCK SHARP DOHME
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf
12
2017Vyzulta
latanoprostene bunod ophthalmic solution
NDA2077952017-Nov-02STANDARDORIG-11
To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
glaucomaBausch and LombBAUSCH AND LOMBhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207795Orig1s000lbl.pdf
13
2017CalquenceacalabrutinibNDA2102592017-Oct-31PRIORITYORIG-11ORPHAN9/21/2015YesYes
To treat adults with mantle cell lymphoma
mantle cell lymphomaCancerAstraZeneca UK LTDASTRAZENECAhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf
14
2017VerzenioabemaciclibNDA2087162017-Sep-28PRIORITYORIG-11Yes
To treat certain advanced or metastatic breast cancers
breast cancerCancerEli Lilly and CoELI LILLY AND COhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf
15
2017SolosecsecnidazoleNDA2093632017-Sep-15PRIORITYORIG-11Treat bacterial vaginosisbacterial vaginosisLupin Inc
SYMBIOMIX THERAPEUTICS, LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf
16
2017AliqopacopanlisibNDA2099362017-Sep-14PRIORITYORIG-11ORPHAN02/05/2015
Treat adults with relapsed follicular lymphoma
follicular lymphoma cancer
Cancer
Bayer Healthcare Pharmaceuticals
BAYER HEALTHCARE PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf
17
2017benznidazolebenznidazoleNDA2095702017-Aug-29PRIORITYORIG-11ORPHAN07/05/2017Yes
Treat children ages 2 to 12 years old with Chagas disease
ChagasChemo Research SLCHEMO RESEARCH SLhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209570lbl.pdf
18
2017Vabomere
meropenem and vaborbactam
NDA2097762017-Aug-29PRIORITYORIG-11
Treat adults with complicated urinary tract infections
UTI
Rempex Pharmaceuticals
REMPEX PHARMS MEDCNS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf
19
2017Besponsa
inotuzumab ozogamicin
BLA7610402017-Aug-17PRIORITYORIG-1ORPHAN03/25/2013Yes
Treat adults with relapsed or refractory acute lymphoblastic leukemia
ALL (leukemia) cancerCancer
Wyeth Pharmaceuticals Inc
WYETH PHARMS INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf
20
2017Mavyret
glecaprevir and pibrentasvir
NDA2093942017-Aug-03PRIORITYORIG-11, 4Yes
Treat adults with chronic hepatitis C virus
HCVAbbvie IncABBVIE INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s000lbl.pdf
21
2017IdhifaenasidenibNDA2096062017-Aug-01PRIORITYORIG-11ORPHAN06/12/2014
Treat relapsed or refractory acute myeloid leukemia
AML (leukemia) cancer
CancerCelgene CorpCELGENE CORPhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf
22
2017Vosevi
sofosbuvir, velpatasvir and voxilaprevir
NDA2091952017-Jul-18PRIORITY
ORIG-1; ORIG-2
1, 4
Treat adults with chronic hepatitis C virus
HCVGilead Sciences Inc
GILEAD SCIENCES INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s000lbl.pdf
23
2017Nerlynxneratinib maleateNDA2080512017-Jul-17STANDARDORIG-1
To reduce the risk of breast cancer returning; For the extended adjuvant treatment of early-stage, HER2-positive breast cancer
breast cancerCancerPuma BiotechnologyPUMA BIOTECHhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf
24
2017TremfyaguselkumabBLA7610612017-Jul-13PRIORITYORIG-1
Treatment of adult patients with moderate-to-severe plaque psoriasis
psoriasisJanssen Biotech, IncJANSSEN BIOTECHhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
25
2017BevyxxabetrixabanNDA2083832017-Jun-23PRIORITYORIG-11
For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness
venous thromoembelism (VTE)
Portola Pharmaceuticals Inc
PORTOLA PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf
26
2017BaxdeladelafloxacinNDA2086102017-Jun-19PRIORITYORIG-11
Treat patients with acute bacterial skin infections
skin infection
Melinta Therapeutics Inc
MELINTA THERAPS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf
27
2017KevzarasarilumabBLA7610372017-May-22PRIORITYORIG-1
Treat adult rheumatoid arthritis
arthritisSanofi Aventis USSANOFI SYNTHELABOhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
28
2017RadicavaedaravoneNDA2091762017-May-05STANDARDORIG-11ORPHAN3/12/2015
Treat patients with amyotrophic lateral sclerosis (ALS)
ALS
Mitsubishi Tanabe Pharma Corp
MITSUBISHI TANABEhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf
29
2017ImfinzidurvalumabBLA7610692017-May-01PRIORITYORIG-1Yes
Treat patients with locally advanced or metastatic urothelial carcinoma
urothelial cancerCancerAstraZeneca UK LTD
ASTRAZENECA UK LTD
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf
30
2017RydaptmidostaurinNDA2079972017-Apr-28PRIORITYORIG-11, EfficacyORPHAN04/28/2010YesTreat acute myeloid leukemia
AML (leukemia) cancer
Cancer
Novartis Pharmaceuticals Corp
NOVARTIS PHARMS CORP
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf
31
2017AlunbrigbrigatinibNDA2087722017-Apr-28PRIORITYORIG-11ORPHAN4/28/2016Yes
Treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
lung cancerCancer
Ariad Pharmaceuticals Inc
ARIADhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf
32
2017TymlosabaloparatideNDA2087432017-Apr-28STANDARDORIG-11, 4
Treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
osteoporosisRadius Health IncRADIUS HEALTH INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf
33
2017Brineuracerliponase alfaBLA7610522017-Apr-27PRIORITYORIG-1ORPHAN4/27/2013YesYes
Treat a specific form of Batten disease
Batten disease
Biomarin Pharmaceuticals, Inc
BIOMARIN PHARMhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761052lbl.pdf
34
2017IngrezzavalbenazineNDA2092412017-Apr-11PRIORITYORIG-11Yes
Treat adults with tardive dyskinesia
tardive dyskenesia
Neurocrine Biosciences Inc
NEUROCRINEhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf
35
2017AustedodeutetrabenazineNDA2080822017-Apr-03STANDARDORIG-11ORPHAN11/05/2014
For the treatment of chorea associated with Huntington’s disease
Huntington's disease
Teva Branded Pharmaceutical Products R and D Inc
TEVA BRANDED PHARM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
36
2017OcrevusocrelizumabBLA7610532017-Mar-28STANDARDORIG-1Yes
Treat patients with relapsing and primary progressive forms of multiple sclerosis
multiple sclerosisGenentech, IncGENENTECH INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf
37
2017DupixentdupilumabBLA7610552017-Mar-28STANDARDORIG-1Yes
Treat adults with moderate-to-severe eczema (atopic dermatitis)
eczema
Regeneron Pharmaceuticals, Inc
REGENERON PHARMACEUTICALS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf
38
2017ZejulaniraparibNDA2084472017-Mar-27PRIORITYORIG-11ORPHAN04/30/2010Yes
For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers
ovarian/fallopian cancer
CancerTesaro IncTESARO INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
39
2017BavencioavelumabBLA7610492017-Mar-23STANDARDORIG-1ORPHAN09/21/2015Yes
Treat metastatic Merkel cell carcinoma
Merkel cell cancerCancerEMD Serono, IncEMD SERONO INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf
40
2017SymproicnaldemedineNDA2088542017-Mar-23STANDARDORIG-11
For the treatment of opioid-induced constipation
constipationShionogi IncSHIONOGI INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf
41
2017XadagosafinamideNDA2071452017-Mar-211Treat Parkinson’s diseaseParkinson's disease
Newron Pharmaceuticals US Inc
US WORLDMEDS LLChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf
42
2017KisqaliribociclibNDA2090922017-Mar-13STANDARDORIG-11Yes
Treat postmenopausal women with a type of advanced breast cancer
breast cancerCancer
Novartis Pharmaceuticals Corp
NOVARTIS PHARMS CORP
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf
43
2017Xermelotelotristat ethylNDA2087942017-Feb-28STANDARDORIG-11ORPHAN03/09/2012
Treat carcinoid syndrome diarrhea
diarrhea
Lexicon Pharmaceuticals INC
LEXICON PHARMS INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208794s000lbl.pdf
44
2017SiliqbrodalumabBLA7610322017-Feb-15PRIORITYORIG-1
Treat adults with moderate-to-severe plaque psoriasis
psoriasis
Valent Pharmaceuticals Luxembourg
VALEANT LUXEMBOURG
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf
45
2017EmflazadeflazacortNDA2086842017-Feb-09STANDARDORIG-11ORPHAN08/16/2013Yes
To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD)
Duchenne's disease
Marathon Pharmaceuticals LLC
PTC THERAPhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf
46
2017ParsabivetelcalcetideNDA2083252017-Feb-081
To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
chronic kidney disease
Kai Pharmaceuticals Inc
KAI PHARMS INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf
47
2017TrulanceplecanatideNDA2087452017-Jan-191
Treat Chronic Idiopathic Constipation (CIC) in adult patients
constipation
Synergy Pharmaceuticals Inc
SYNERGY PHARMShttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745lbl.pdf
48
2016SpinrazanusinersenNDA2095312016-Dec-23PRIORITYORIG-11ORPHAN4/18/2011YesYes
Treatment of spinal muscular atrophy in pediatric and adult patients.
spinal muscular atrophy
Biogen IDEC IncBIOGENhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209531lbl.pdf
49
2016RubracarucaparibNDA2091152016-Dec-19PRIORITYORIG-11ORPHAN7/31/2012Yes
Treatment of a certain type of ovarian cancer
ovarian cancerCancerClovis Oncology IncCLOVIS ONCOLOGYhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf
50
2016EucrisacrisaboroleNDA2076952016-Dec-14STANDARDORIG-11
Treatment of atopic dermatitis in patients two years or older
dermatitis
Anacor Pharmaceuticals Inc
ANACOR PHARMS INC (now owned by Pfizer)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207695s000lbl.pdf
51
2016ZinplavabezlotoxumabBLA7610462016-Oct-21PRIORITYORIG-1J06BB21Yes
Reduce recurrence of Clostridium difficile infection in patients 18 and older
c. diff infection
Merck Sharp and Dohme Corp
MERCK SHARP DOHME
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf
52
2016LartruvoolaratumabBLA7610382016-Oct-1909/11/2016PRIORITYORIG-1ORPHAN10/09/2014YesYes
Treatment of certain types of soft tissue sarcoma in adults
soft tissue cancer (sarcoma)
CancerEli Lilly and CompanyELI LILLY AND COhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761038lbl.pdf
53
2016Exondys 51eteplirsenNDA2064882016-Sep-19PRIORITYORIG-11ORPHAN10/23/2007YesYes
Treatment of Duchenne muscular dystrophy
Duchenne's disease
Sarepta Therapeutics Inc
SAREPTA THERAPS INC
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206488lbl.pdf
54
2016AdlyxinlixisenatideNDA2084712016-Jul-2701/02/2013STANDARDORIG-11A10BX10
Improvement of glycemic control
glycemic control
Sanofi-Aventis US LLC
SANOFI-AVENTIS UShttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf
55
2016Xiidra
lifitegrast opthalmic solution
NDA2080732016-Jul-11PRIORITYORIG-11
Treatment of symptoms of dry eye disease
dry eye
Shire Development LLC
SHIRE DEV LLChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208073s000lbl.pdf
56
2016Epclusa
sofosbuvir and velpatasvir
NDA2083412016-Jun-28PRIORITYORIG-11, 4
Designated in 2017 Not approved
YesYes
Treatment of all six major forms of hepatitis C virus
HCVGilead Sciences Inc
GILEAD SCIENCES INC
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf
57
2016NETSPOT
gallium 68 dotatate
NDA2085472016-Jun-01PRIORITYORIG-11ORPHAN12/31/2013
Diagnostic imaging agent to detect recurrent prostate cancer
prostate cancer diagnostic
Advanced Accelerator Applications USA Inc
AAA USA INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf
58
2016Axuminfluciclovine F 18NDA2080542016-May-27PRIORITYORIG-11V09IX12
Positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
prostate cancer diagnostic
Blue Earth Diagnostics LTD
BLUE EARTH DIAGNOSTICS
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf
59
2016Ocalivaobeticholic acidNDA2079992016-May-2712/12/2016PRIORITYORIG-11A05AA04ORPHAN04/09/2008
Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.
cholangitis infection
Intercept Pharmaceuticals Inc
INTERCEPT PHARMS INC
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf
60
2016ZinbrytadaclizumabBLA7610292016-May-27STANDARDORIG-1
Treatment of adults with relapsing forms of multiple sclerosis (MS)
multiple sclerosisBiogen IncBIOGENhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf
61
2016TecentriqatezolizumabBLA7610342016-May-18STANDARDORIG-1Yes
Treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment.
urothelial cancerCancerGenentech IncGENENTECHhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf
62
2016NuplazidpimavanserinNDA2073182016-Apr-29PRIORITYORIG-11Yes
Treatment of hallucinations and delusions associated with Parkinson’s disease.
Parkinson's disease
Acadia Pharmaceuticals Inc
ACADIA PHARMS INC https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf
63
2016VenclextavenetoclaxNDA2085732016-Apr-115/12/2016PRIORITYORIG-11L01XX52ORPHAN09/20/2012Yes
Treatment of chronic lymphocytic leukemia (CLL)
CLL (leukemia) cancerCancerAbbvie IncABBVIE INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf
64
2016Defiteliodefibrotide sodiumNDA2081142016-Mar-3018/10/2013PRIORITYORIG-11B01AX01ORPHAN05/21/2003Yes
Treatment of hepatic veno-occlusive disease (VOD)
veno-occulsive disease
Gentium SpaJAZZ PHARMS INC https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114Orig1s000Lbl.pdf
65
2016CinqairreslizumabBLA7610332016-Mar-2316/08/2016STANDARDORIG-1R03DX08
Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma)
asthma
Teva Respuratory, LLC
TEVA RESPIRATORY LLC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf
66
2016TaltzixekizumabBLA1255212016-Mar-2225/04/2016STANDARDORIG-1L04AC13
Treatment of moderate to severe plaque psoriasis in adults
psoriasisEli Lilly and CompanyELI LILLY AND COhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf
67
2016AnthimobiltoxaximabBLA1255092016-Mar-18STANDARDORIG-1ORPHAN06/09/2006
Treatment of inhalational anthrax in combination with appropriate antibacterial drugs.
anthrax
Elusys Therapeutics, Inc
ELUSYS THERAPEUTICS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf
68
2016BriviactbrivaracetamNDA2058362016-Feb-1814/01/2016STANDARDORIG-112, 31N03AX23
Add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.
epilepsyUCB IncUCB INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836Orig1s000,205837Orig1s000,205838Orig1s000lbl.pdf
69
2016Zepatier
elbasvir and grazoprevir
NDA2082612016-Jan-2822/07/2016PRIORITYORIG-11, 4J05AYes
Treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
HCV
Merck Sharp and Dohme Corp
MERCK SHARP DOHME
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208261Orig1s000lbl.pdf
70
2015ZurampiclesinuradNDA2079882015-Dec-2218/02/2016STANDARDORIG-1M04AB05
To treat high blood uric acid levels associated with gout
goutArdea Biosciences Inc
IRONWOOD PHARMS INC
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf
71
2015UptraviselexipagNDA2079472015-Dec-2212/05/2016STANDARDORIG-11B01AC27ORPHAN04/30/2010
To treat pulmonary arterial hypertension
hypertension
Actelion Pharmaceuticals LTD
ACTELION PHARMS LTD
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207947s000lbl.pdf
72
2015BridionsugammadexNDA0222252015-Dec-1525/07/2008PRIORITYORIG-11V03AB35
To reverse effects of neuromuscular blocking drugs used during surgery
neuromuscular blocking
Organon USA Inc
ORGANON SUB MERCK
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf
73
2015AlecensaalectinibNDA2084342015-Dec-11PRIORITYORIG-11L01XE36ORPHAN01/27/2015Yes
To treat ALK-positive lung cancer
lung cancerCancerHoffman La Roche IncHOFFMAN-LA ROCHEhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf
74
2015Kanumasebelipase alfaBLA1255612015-Dec-0828/08/2015N/AORIG-1N/AA16AB14ORPHAN07/01/2010YesYesYes
To treat patients with a rare disease known as lysosomal acid lipase (LAL) deficiency
LAL deficiency
Synageva Biopharma Corp
ALEXION PHARMhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125561s000lbl.pdf
75
2015EmplicitielotuzumabBLA7610352015-Nov-3011/05/2016N/AORIG-1N/AL01XC23ORPHAN09/01/2011Yes
To treat people with multiple myeloma who have received one to three prior medications
multiple myeloma cancer
Cancer
Bristol Myers Squibb Company
BRISTOL MYERS SQUIBB
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf
76
2015PortrazzanecitumumabBLA1255472015-Nov-2415/02/2016N/AORIG-1N/AL01XC22ORPHAN11/20/2015Yes
To treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer
lung cancerCancerEli Lilly and CompanyELI LILLY COhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf
77
2015NinlaroixazomibNDA2084622015-Nov-2021/11/2016PRIORITYORIG-11L01XX50ORPHAN02/18/2011
To treat people with multiple myeloma who have received at least one prior therapy
multiple myeloma cancer
Cancer
Millennium Pharmaceuticals Inc
MILLENNIUM PHARMShttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf
78
2015DarzalexdaratumumabBLA7610362015-Nov-1620/05/2016N/AORIG-1N/AL01XC24ORPHAN05/06/2013Yes
To treat patients with multiple myeloma who have received at least three prior treatments.
multiple myeloma cancer
CancerJanssen Biotech, IncJANSSEN BIOTECHhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf
79
2015TagrissoosimertinibNDA2080652015-Nov-1302/02/2016PRIORITYORIG-11L01XE35ORPHAN09/04/2014Yes
To treat certain patients with non-small cell lung cancer
lung cancerCancer
AstraZeneca Pharmaceuticals LP
ASTRAZENECA PHARMS
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf
80
2015CotelliccobimetinibNDA2061922015-Nov-1020/11/2015PRIORITYORIG-11L01XE38ORPHAN01/31/2014Yes
To be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation)
melanoma cancerCancerGenentech IncGENETECH INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf
81
2015Genvoya
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
NDA2075612015-Nov-0519/11/2015STANDARDORIG-11,4J05AR18Yes
For use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
HIVGilead Sciences Inc
GILEAD SCIENCES INC
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf
82
2015NucalamepolizumabBLA1255262015-Nov-0402/12/2015N/AORIG-1N/AR03DX09
For use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older
asthmaGlaxoSmithKline LLC
GLAXOSMITHKLINE LLC
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf
83
2015Strensiqasfotase alfaBLA1255132015-Oct-2328/08/2015N/AORIG-1N/AA16AB13ORPHAN09/12/2008YesYesYes
To treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
hypophosphatasia
Alexion Pharmaceuticals Inc
ALEXION PHARMhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf
84
2015YondelistrabectedinNDA2079532015-Oct-2317/09/2007PRIORITYORIG-11L01CX01ORPHAN09/30/2004
To treat specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).
soft tissue cancer (sarcoma)
CancerJanssen Products LPJANSSEN PRODShttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207953s000lbl.pdf
85
2015Veltassa
patiromer for oral suspension
NDA2057392015-Oct-21STANDARDORIG-11
To treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.
hyperkalemiaRelypsa IncRELYPSA INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf
86
2015PraxbindidarucizumabBLA7610252015-Oct-1620/11/2015N/AORIG-1N/AV03AB37ORPHAN05/28/2015Yes
For use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
emergency coagulant
Boehringer Ingelheim Pharmaceuticals Inc
BOEHRINGER INGELHEIM
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761025lbl.pdf
87
2015Aristada
aripiprazole lauroxil
NDA2075332015-Oct-06STANDARDORIG-11
To treat adults with schizophrenia
schizophreniaAlkermes IncALKERMES INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207533s000lbl.pdf
88
2015Tresiba
insulin degludec injection
NDA2033142015-Sep-2521/01/2013STANDARDORIG-11A10AE06
To improve blood sugar (glucose) control in adults with diabetes mellitus
diabetesNovo Nordisk IncNOVO NORDISK INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf
89
2015Lonsurf
trifluridine and tipiracil
NDA2079812015-Sep-22STANDARDORIG-11Yes
To treat patients with an advanced form of colorectal cancer who are no longer responding to other therapies
colorectal cancerCancerTaiho Oncology IncTAIHO ONCOLOGYhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf
90
2015VraylarcariprazineNDA2043702015-Sep-17STANDARD
ORIG-1; ORIG-2
12, 31N05AX15
To treat schizophrenia and bipolar disorder in adults
schizophrenia, bipolar
Forest Research Institute Inc
FOREST RES INST INChttps://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204370lbl.pdf
91
2015Xuridenuridine triacetateNDA2081692015-Sep-04PRIORITYORIG-112, 31A16AX13ORPHAN08/09/2013YesYes
To treat patients with hereditary orotic aciduria
orotic aciduria
Wellstat Therapeutics Corp
WELLSTAT THERAPhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208169s000lbl.pdf
92
2015VarubirolapitantNDA2065002015-Sep-02STANDARDORIG-112, 31A04AD14
To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis)
chemo-induced nausea
Tesaro IncTESARO INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206500s000lbl.pdf
93
2015RepathaevolocumabBLA1255222015-Aug-2717/07/2015N/AORIG-1N/AC10AX13ORPHAN09/12/2013
To treat certain patients with high cholesterol
high cholesterolAmgen IncAMGEN INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf
94
2015AddyiflibanserinNDA0225262015-Aug-18STANDARDORIG-11G02CX02
To treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
hypoactive sexual desire disorder
Sprout Pharmaceuticals Inc
SPROUT PHARMShttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf
95
2015DaklinzadaclatasvirNDA2068432015-Jul-2422/08/2014PRIORITYORIG-11J05AX14
To treat chronic hepatitis C virus (HCV) genotype 3 infections
HCV
Bristol Myers Squibb Co
BRISTOL-MYERS SQUIBB
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843Orig1s000lbl.pdf
96
2015OdomzosonidegibNDA2052662015-Jul-2414/08/2015STANDARDORIG-11L01XX48
To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
basal cell cancer Cancer
Novartis Pharmaceuticals Corp
NOVARTIS PHARMS CORP
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266s000lbl.pdf
97
2015PraluentalirocumabBLA1255592015-Jul-2423/09/2015N/AORIG-1N/AC10AX14
To treat certain patients with high cholesterol
high cholesterolSanofi Aventis USSANOFI AVENTIShttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf
98
2015RexultibrexpiprazoleNDA2054222015-Jul-10STANDARD
ORIG-1; ORIG-2
1N05AX16
To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder
schizophrenia, depressive disorder
Otsuka Pharmaceutical
OTSUKA PHARM CO LTD
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422s000lbl.pdf
99
2015Entrestosacubitril/valsartanNDA2076202015-Jul-0719/11/2015PRIORITYORIG-11C09DX04YesTo treat heart failureheart failure
Novartis Pharmaceuticals Corp
NOVARTIS PHARMS CORP
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207620Orig1s000lbl.pdf
100
2015Orkambi
lumacaftor 200 mg/ivacaftor 125 mg
NDA2060382015-Jul-0219/11/2015PRIORITYORIG-11R07AX30ORPHAN06/30/2014YesYesTo treat cystic fibrosiscystic fibrosis
Vertex Pharmaceuticals Inc
VERTEX PHARMS INChttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf
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