Novel Drug Approvals for 2021

 

Advancing Health through Innovation: New Drug Approvals 2021 (PDF - 9 MB)

What are "Novel" Drugs?

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.

FDA Novel Drug Therapy Approvals for 2021

In 2021, CDER approved 50 new drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs). The active ingredient or ingredients in a new drug have never before been approved in the U.S. The novel drugs CDER approved in 2021 are collectively notable for their potential positive impact and unique contributions to patient care.

CDER’s novel drug approvals for 2021 are listed below. For more information, download the report Advancing Health Through Innovation: New Drug Therapy Approvals for 2021.

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date*
50.	Adbry	tralokinumab-ldrm	12/27/2021	To treat moderate-to-severe atopic dermatitis Drug Trials Snapshot
49.	Leqvio	inclisiran	12/22/2021	To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy Drug Trials Snapshot
48.	Vyvgart	efgartigimod alfa-fcab	12/17/2021	To treat generalized myasthenia gravis Press Release Drug Trials Snapshot
47.	Tezspire	tezepelumab-ekko	12/17/2021	To treat severe asthma as an add-on maintenance therapy Drug Trials Snapshot
46.	Cytalux	pafolacianine	11/29/2021	To help identify ovarian cancer lesions  Press Release Drug Trials Snapshot
45.	Livtencity	maribavir	11/23/2021	To treat post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV Press Release Drug Trials Snapshot
44.	Voxzogo	vosoritide	11/19/2021	To improve growth in children five years of age and older with achondroplasia and open epiphyses Press Release Drug Trials Snapshot
43.	Besremi	ropeginterferon alfa-2b-njft	11/12/2021	To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells Press Release Drug Trials Snapshot
42.	Scemblix	asciminib	10/29/2021	To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria Drug Trials Snapshot
41.	Tavneos	avacopan	10/7/2021	To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids Drug Trial Snapshot
40.	Livmarli	maralixibat	9/29/2021	To treat cholestatic pruritus associated with Alagille syndrome Drug Trial Snapshot
39.	Qulipta	atogepant	9/28/2021	To prevent episodic migraines Drug Trial Snapshot
38.	Tivdak	tisotumab vedotin-tftv	9/20/2021	To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy Drug Trial Snapshot
37.	Exkivity	mobocertinib	9/15/2021	To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations Drug Trials Snapshot
36.	Skytrofa	lonapegsomatropin-tcgd	8/25/2021	To treat short stature due to inadequate secretion of endogenous growth hormone Drug Trial Snapshot
35.	Korsuva	difelikefalin	8/23/2021	To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations Drug Trials Snapshot
34.	Welireg	belzutifan	8/13/2021	To treat von Hippel-Lindau disease under certain conditions Drug Trials Snapshot
33.	Nexviazyme	avalglucosidase alfa-ngpt	8/6/2021	To treat late-onset Pompe disease Press Release Drug Trials Snapshot
32.	Saphnelo	anifrolumab-fnia	7/30/2021	To treat moderate-to severe systemic lupus erythematousus along with standard therapy Drug Trials Snapshots
31.	Bylvay	odevixibat	7/20/2021	To treat pruritus Drug Trials Snapshots
30.	Rezurock	belumosudil	7/16/2021	To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy Drug Trials Snapshot
29.	Fexinidazole	fexinidazole	7/16/2021	To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense Drug Trials Snapshot
28.	Kerendia	finerenone	7/9/2021	To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes Drug Trials Snapshot
27.	Rylaze	asparaginase erwinia chrysanthemi (recombinant)-rywn	6/30/2021	To treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen Press Release Drug Trials Snapshots
26.	Aduhelm	aducanumab-avwa	6/7/2021	To treat Alzheimer’s disease Press Release Drug Trials Snapshots
25.	Brexafemme	ibrexafungerp	6/1/2021	To treat vulvovaginal candidiasis Drug Trials Snapshots
24.	Lybalvi	olanzapine and samidorphan	5/28/2021	To treat schizophrenia and certain aspects of bipolar I disorder Drug Trials Snapshot
23.	Truseltiq	infigratinib	5/28/2021	To treat cholangiocarcinoma whose disease meets certain criteria Drug Trials Snapshot
22.	Lumakras	sotorasib	5/28/2021	To treat types of non-small cell lung cancer  Press Release Drug Trials Snapshot
21.	Pylarify	piflufolastat F 18	5/26/2021	To identify prostate-specific membrane antigen-positive lesions in prostate cancer Drug Trials Snapshot
20.	Rybrevant	amivantamab-vmjw	5/21/2021	To treat a subset of non-small cell lung cancer Drug Trials Snapshot Press Release
19.	Empaveli	pegcetacoplan	5/14/2021	To treat paroxysmal nocturnal hemoglobinuria Drug Trials Snapshot
18.	Zynlonta	loncastuximab tesirine-lpyl	4/23/2021	To treat certain types of relapsed or refractory large B-cell lymphoma Drug Trials Snapshot
17.	Jemperli	dostarlimab-gxly	4/22/2021	To treat endometrial cancer Press Release Drug Trials Snapshot
16.	Nextstellis	drospirenone and estetrol	4/15/2021	To prevent pregnancy Drug Trials Snapshot
15.	Qelbree	viloxazine	4/2/2021	To treat attention deficit hyperactivity disorder Drug Trials Snapshot
14.	Zegalogue	dasiglucagon	3/22/2021	To treat severe hypoglycemia Drug Trials Snapshot
13.	Ponvory	ponesimod	3/18/2021	To treat relapsing forms of multiple sclerosis Drug Trials Snapshot
12.	Fotivda	tivozanib	3/10/2021	To treat renal cell carcinoma Drug Trials Snapshot
11	Azstarys	serdexmethylphenidate and dexmethylphenidate	3/2/2021	To treat attention deficit hyperactivity disorder Drug Trials Snapshot
10.	Pepaxto	melphalan flufenamide	2/26/2021	To treat relapsed or refractory multiple myeloma Drug Trials Snapshot
9.	Nulibry	fosdenopterin	2/26/2021	To reduce the risk of mortality in molybdenum cofactor deficiency Type A Press Release Drug Trials Snapshot
8.	Amondys 45	casimersen	2/25/2021	To treat Duchenne muscular dystrophy Press Release Drug Trials Snapshot
7.	Cosela	trilacicilib	2/12/2021	To mitigate chemotherapy-induced myelosuppression in small cell lung cancer Press Release Drug Trials Snapshot
6.	Evkeeza	evinacumab-dgnb	2/11/2021	To treat homozygous familial hypercholesterolemia Drug Trials Snapshot
5.	Ukoniq	umbralisib	2/5/2021	To treat marginal zone lymphoma and follicular lymphoma Drug Trials Snapshot
4.	Tepmetko	tepotinib	2/3/2021	To treat non-small cell lung cancer Drug Trials Snapshot
3.	Lupkynis	voclosporin	1/22/2021	To treat lupus nephritis Drug Trials Snapshot
2.	Cabenuva	cabotegravir and rilpivirine (co-packaged)	1/21/2021	To treat HIV Press Release Drug Trials Snapshot
1.	Verquvo	vericiguat	1/19/2021	To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure Drug Trials Snapshot

*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name) .