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