No.
Drug Name
Active Ingredient
Approval Date
FDA-approved use on approval date*
1
Verquvo
vericiguat
1/19/21
To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure
2
Cabenuva
cabotegravir and rilpivirine (co-packaged)
1/21/21
To treat HIV
3
Lupkynis
voclosporin
1/22/21
To treat lupus nephritis
4
Tepmetko
tepotinib
2/3/21
To treat non-small cell lung cancer
5
Ukoniq
umbralisib
2/5/21
To treat marginal zone lymphoma and follicular lymphoma
6
Evkeeza
evinacumab-dgnb
2/11/21
To treat homozygous familial hypercholesterolemia
7
Cosela
trilacicilib
2/12/21
To mitigate chemotherapy-induced myelosuppression in small cell lung cancer
8
Amondys 45
casimersen
2/25/21
To treat Duchenne muscular dystrophy
9
Nulibry
fosdenopterin
2/26/21
To reduce the risk of mortality in molybdenum cofactor deficiency Type A
10
Pepaxto
melphalan flufenamide
2/26/21
To treat relapsed or refractory multiple myeloma
11
Azstarys
serdexmethylphenidate and dexmethylphenidate
3/2/21
To treat attention deficit hyperactivity disorder
12
Fotivda
tivozanib
3/10/21
To treat renal cell carcinoma
13
Ponvory
ponesimod
3/18/21
To treat relapsing forms of multiple sclerosis
14
Zegalogue
dasiglucagon
3/22/21
To treat severe hypoglycemia
15
Qelbree
viloxazine
4/2/21
To treat attention deficit hyperactivity disorder
16
Nextstellis
drospirenone and estetrol
4/15/21
To prevent pregnancy
17
Jemperli
dostarlimab-gxly
4/22/21
To treat endometrial cancer
18
Zynlonta
loncastuximab tesirine-lpyl
4/23/21
To treat certain types of relapsed or refractory large B-cell lymphoma
19
Empaveli
pegcetacoplan
5/14/21
To treat paroxysmal nocturnal hemoglobinuria
20
Rybrevant
amivantamab-vmjw
5/21/21
To treat a subset of non-small cell lung cancer
21
Pylarify
piflufolastat F 18
5/26/21
To identify prostate-specific membrane antigen-positive lesions in prostate cancer
22
Lumakras
sotorasib
5/28/21
To treat types of non-small cell lung cancer
23
Truseltiq
infigratinib
5/28/21
To treat cholangiocarcinoma whose disease meets certain criteria
24
Lybalvi
olanzapine and samidorphan
5/28/21
To treat schizophrenia and certain aspects of bipolar I disorder
25
Brexafemme
ibrexafungerp
6/1/21
To treat vulvovaginal candidiasis
26
Aduhelm
aducanumab-avwa
6/7/21
To treat Alzheimer’s disease
27
Rylaze
asparaginase erwinia chrysanthemi (recombinant)-rywn
6/30/21
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
28
Kerendia
finerenone
7/9/21
To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes
29
feinidazole
fexinidazole
7/16/21
To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense
30
Rezurock
belumosudil
7/16/21
To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
31
Bylvay
odevixibat
7/20/21
To treat pruritus
32
Saphnelo
anifrolumab-fnia
7/30/21
To treat moderate-to severe systemic lupus erythematousus along with standard therapy
33
Nexviazyme
avalglucosidase alfa-ngpt
8/6/21
To treat late-onset Pompe disease
34
Welireg
belzutifan
8/13/21
To treat von Hippel-Lindau disease under certain conditions
35
Korsuva
difelikefalin
8/23/21
To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations
36
Skytofa
lonapegsomatropin-tcgd
8/25/21
To treat short stature due to inadequate secretion of endogenous growth hormone
37
Exkivity
mobocertinib
9/15/21
To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
38
Tivdak
tisotumab vedotin-tftv
9/20/21
To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
39
Qulipta
atogepant
9/28/21
To prevent episodic migraines
40
Livmarli
maralixibat
9/29/21
To treat cholestatic pruritus associated with Alagille syndrome
41
Tavneos
avacopan
10/7/21
To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids
42
Scemblix
asciminib
10/29/21
To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria
43
Besremi
ropeginterferon alfa-2b-njft
11/12/21
To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells
44
Voxzogo
vosoritide
11/19/21
To improve growth in children five years of age and older with achondroplasia and open epiphyses
45
Livtencity
maribavir
11/23/21
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
46
Cytalux
pafolacianine
11/29/21
To help identify ovarian cancer lesions
47
Tezspire
tezepelumab-ekko
12/17/21
To treat severe asthma as an add-on maintenance therapy
48
Vyvgart
efgartigimod alfa-fcab
12/17/21
To treat generalized myasthenia gravis
