1. 1. Introduction
2. 2. Abiraterone acetate (Zytiga®)
3. 3. Alcaftadine (Lastacaft®)
4. 4. Apixaban (Eliquis®)
5. 5. Avanafil (Zepeed®, Stendra®)
6. 6. Azilsartan kamedoxomil (Edarbi®)
7. 7. Bilastine (Bilaxten®)
8. 8. Boceprevir (Victrelis®)
9. 9. Brentuximab vedotin (Adcetris®)
10. 10. Ceftaroline fosamil acetate (Teflaro®)
11. 11. Crizotinib (Xalkori®)
12. 12. Edoxaban tosilate (Lixiana®)
13. 13. Eldecalcitol (Edirol®)
14. 14. Gabapentin enacarbil (Horizant®)
15. 15. Icotinib hydrochloride (Conmana®)
16. 16. Linagliptin (Trajenta®)
17. 17. Lurasidone hydrochloride (Latuda®)
18. 18. Mirabegron (Betains®)
19. 19. Retigabine/Ezogabine (Trobalt®/Potiga®)
20. 20. Rilpivirine hydrochloride (Edurant®)
21. 21. Ruxolitinib phosphate (Jakafi®)
22. 22. Telaprevir (Incivek®)
23. 23. Ticagrelor (Brilique®)
24. 24. Vandetanib (Caprelsa®, Zactima®, Zictifa®)
25. 25. Vemurafenib (Zelboraf®)
26. 26. Vilazodone hydrochloride (Viibryd®)
27. 27. Zucapsaicin (Zuacta®)
28. 
    

No.	Drug  Name	Active Ingredient	Date	FDA-approved use on approval date
45.	Zurampic	lesinurad	12/22/2015	To treat high blood uric acid levels associated with gout Press Release Drug Trials Snapshot
44.	Uptravi	selexipag	12/22/2015	To treat pulmonary arterial hypertension Press Release Drug Trials Snapshot
43.	Bridion	sugammadex	12/15/2015	To reverse effects of neuromuscular blocking drugs used during surgery Press Release Drug Trials Snapshot
42.	Alecensa	alectinib	12/11/2015	To treat ALK-positive lung cancer Press Release Drug Trials Snapshot
41.	Kanuma	sebelipase alfa	12/8/2015	To treat patients with a rare disease known as lysosomal acid lipase (LAL) deficiency Press Release Drug Trials Snapshot
40.	Empliciti	elotuzumab	11/30/2015	To treat people with multiple myeloma who have received one to three prior medications Press Release Drug Trials Snapshot
39.	Portrazza	necitumumab	11/24/2015	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 Press Release Drug Trials Snapshot
38.	Ninlaro	ixazomib	11/20/2015	To treat people with multiple myeloma who have received at least one prior therapy Press Release Drug Trials Snapshot
37.	Darzalex	daratumumab	11/16/2015	To treat patients with multiple myeloma who have received at least three prior treatments. Press Release Drug Trials Snapshot
36.	Tagrisso	osimertinib	11/13/2015	To treat certain patients with non-small cell lung cancer Press Release Drug Trials Snapshot
35.	Cotellic	cobimetinib	11/10/2015	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) Press Release Drug Trials Snapshot
34.	Genvoya	a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	11/5/2015	For use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older Press Release Drug Trials Snapshot
33.	Nucala	mepolizumab	11/4/2015	For use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Press Release Drug Trials Snapshot
32.	Strensiq	asfotase alfa	10/23/2015	To treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP).  Press Release Drug Trials Snapshot
31.	Yondelis	trabectedin	10/23/2015	To treat specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).  Press Release Drug Trials Snapshot
30.	Veltassa	patiromer for oral suspension	10/21/2015	To treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Press Release Drug Trials Snapshot
29.	Praxbind	idarucizumab	10/16/2015	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.  Press Release Drug Trials Snapshot
28.	Aristada	aripiprazole lauroxil	10/6/2015	To treat adults with schizophrenia Press Release Drug Trials Snapshot
27.	Tresiba	insulin degludec injection	9/25/2015	To improve blood sugar (glucose) control in adults with diabetes mellitus Press Release Drug Trials Snapshot
26.	Lonsurf	trifluridine and tipiracil	9/22/2015	To treat patients with an advanced form of colorectal cancer who are no longer responding to other therapies Press Release Drug Trials Snapshot
25.	Vraylar	cariprazine	9/17/2015	To treat schizophrenia and bipolar disorder in adults Press Release Drug Trials Snapshot
24.	Xuriden	uridine triacetate	9/4/2015	To treat patients with hereditary orotic aciduria Press Release Drug Trials Snapshot
23.	Varubi	rolapitant	9/2/2015	To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis) Press Release Drug Trials Snapshot
22.	Repatha	evolocumab	8/27/2015	To treat certain patients with high cholesterol Press Release Drug Trials Snapshot
21.	Addyi	flibanserin	8/18/2015	To treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women Press Release Drug Trials Snapshot
20.	Daklinza	daclatasvir	7/24/2015	To treat chronic hepatitis C virus (HCV) genotype 3 infections Press Release Drug Trials Snapshot
19.	Odomzo	sonidegib	7/24/2015	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. Press Release Drug Trials Snapshot
18.	Praluent	alirocumab	7/24/2015	To treat certain patients with high cholesterol Press Release Drug Trials Snapshot
17.	Rexulti	brexpiprazole	7/10/2015	To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder Press Release  Drug Trials Snapshot (treatment of major depressive disorder) Drug Trials Snapshot (treatment of schizophrenia)
16.	Entresto	sacubitril/valsartan	7/7/2015	To treat heart failure Press Release Drug Trials Snapshot
15.	Orkambi	lumacaftor 200 mg/ivacaftor 125 mg	7/2/2015	To treat cystic fibrosis Press Release Drug Trials Snapshot
14.	Kengreal	cangrelor	6/22/2015	To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention  Press Release Drug Trials Snapshot
13.	Viberzi	eluxadoline	5/27/2015	To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.  Press Release Drug Trials Snapshot
12.	Kybella	deoxycholic acid	4/29/2015	To treat adults with moderate-to-severe fat below the chin, known as submental fat Press Release Drug Trials Snapshot
11.	Corlanor	ivabradine	4/15/2015	To reduce hospitalization from worsening heart failure. Press Release Drug Trials Snapshot
10.	Cholbam	cholic acid	3/17/2015	To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders Press Release Drug Trials Snapshot (bile acid synthesis disorders) Drug Trials Snapshot (peroxisomal disorders)
9.	Unituxin	dinutuximab	3/10/2015	To treat pediatric patients with high-risk neuroblastoma Press Release Drug Trials Snapshot
8.	Cresemba capsuleinjection	isavuconazonium sulfate	3/6/2015	To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections Press Release  Drug Trials Snapshot (aspergillosis) Drug Trials Snapshot (mucormycosis)
7.	Avycaz	ceftazidime-avibactam	2/25/2015	To treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  Press Release Drug Trials Snaphot (cIAI)  Drug Trials Snapshot (cUTI)
6.	Farydak	panobinostat	2/23/2015	To treat patients with multiple myeloma Press Release Drug Trials Snapshot
5.	Lenvima	lenvatinib	2/13/2015	To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Press Release Drug Trials Snapshot
4.	Ibrance	palbociclib	2/3/2015	To treat advanced (metastatic) breast cancer Press Release Drug Trials Snapshot
3.	Natpara	parathyroid horomone	1/23/2015	To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism Press Release Drug Trials Snapshot
2.	Cosentyx	secukinumab	1/21/2015	To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot
1.	Savaysa	edoxaban	1/8/2015	To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem Press Release Drug Trials Snapshot (atrial fibrillation)  Drug Trials Snapshot (venous thromboembolism)

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

Related Information

• New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Drug Innovation

Novel Drug Approvals for 2018Novel Drug Approvals for 2017Novel Drug Approvals for 2016Novel Drug Approvals for 2015

No.	Drug  Name	Active Ingredient	Approval Date	FDA-approved use on approval date
22.	Spinraza	nusinersen	12/23/2016	To treat children and adults with spinal muscular atrophy (SMA) Press Release Drug Trials Snapshot
21.	Rubraca	rucaparib	12/19/2016	To treat women with a certain type of ovarian cancer Press Release  Drug Trials Snapshot
20.	Eucrisa	crisaborole	12/14/2016	To treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older Press Release Drug Trials Snapshot
19.	Zinplava	bezlotoxumab	10/21/2016	To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older Drug Trials Snapshot
18.	Lartruvo	olaratumab	10/19/2016	To treat adults with certain types of soft tissue sarcoma Press Release  Drug Trials Snapshot
17.	Exondys 51	eteplirsen	9/19/2016	To treat patients with Duchenne muscular dystrophy  Press Release Drug Trials Snapshot
16.	Adlyxin	lixisenatide	7/27/2016	To improve glycemic control (blood sugar levels) Press Release Drug Trials Snapshot
15.	Xiidra	lifitegrast ophthalmic solution	7/11/2016	To treat the signs and symptoms of dry eye disease Press Release Drug Trials Snapshot
14.	Epclusa	sofosbuvir and velpatasvir	6/28/2016	To treat all six major forms of hepatitis C virus  Press Release Drug Trials Snapshot
13.	NETSPOT	gallium Ga 68 dotatate	6/1/2016	A diagnostic imaging agent to detect rare neuroendocrine tumors Press Release Drug Trials Snapshot
12.	Axumin	fluciclovine F 18	5/27/2016	A  new diagnostic imaging agent to detect recurrent prostate cancer Press release Drug Trials Snapshot
11.	Ocaliva	obeticholic acid	5/27/2016	To treat rare, chronic liver disease Press release Drug Trials Snapshot
10.	Zinbryta	daclizumab	5/27/2016	To treat multiple sclerosis Press Release Drug Trials Snapshot
9.	Tecentriq	atezolizumab	5/18/2016	To treat urothelial carcinoma, the most common type of bladder cancer Press Release Drug Trials Snapshot
8.	Nuplazid	pimavanserin	4/29/2016	To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease Press Release Drug Trials Snapshot
7.	Venclexta	venetoclax	4/11/2016	For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality Press Release Drug Trials Snapshot
6.	Defitelio	defibrotide sodium	3/30/3016	To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation Press Release Drug Trials Snapshot
5.	Cinqair	reslizumab	3/23/2016	To treat severe asthma Press Release Drug Trials Snapshot
4.	Taltz	ixekizumab	3/22/2016	To treat adults with moderate-to-severe plaque psoriasis.  Press Release Drug Trials Snapshot
3.	Anthim	obiltoxaximab	3/18/2016	To treat inhalational anthrax in combination with appropriate antibacterial drugs. Press Release Drug Trials Snapshot
2.	Briviact	brivaracetam	2/18/2016	To treat partial onset seizures in patients age 16 years and older with epilepsy. Press Release Drug Trials Snapshot
1.	Zepatier	elbasvir and grazoprevir	1/28/2016	To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Press Release Drug Trials Snapshot

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.