Food & Drug Administration Approved Drugs in 2021

The Food and Drug Administration (FDA) is in charge of pharmaceutical industry law in order to protect public health.  The FDA’s objective isn’t simply to ensure that high criteria for drug efficacy and safety are met by products and patients, but also to balance the lengthy, costly process of maintaining these standards against the need to provide access to effective therapies sooner and with less outlays. New medicine and device approval takes an average of 12 and 7 years, respectively, from pre-clinical study to approval. Medical device development costs millions of dollars, and a recent study shows that the total cost of a new medicine exceeds $1 billion. FDA processes can be daunting for investigators seeking approval for new drugs and devices.

Between 2018 and 2021, 221 novel drugs approved by the US Food and Drug Administration (FDA) were assessed based on approval numbers by year, active ingredients, modalities, mode of administration, approval times, and accelerated assessment classifications.

Notwithstanding the changes wrought by COVID-19, the FDA’s Center for Drug Evaluation and Research (CDER) accepted 50 new medicines in 2021.

Some of these products have never been tested in humans. The following is a list of novel molecular entities and therapeutic biological products approved by the CDER in 2021. Vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, and other products approved by the Center for Biologics Evaluation and Research in 2021 are not included in this list.

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date
1 Adbry tralokinumab-ldrm 12/27/2021 Atopic dermatitis (mild-to-severe)
2 Leqvio inclisiran 12/22/2021 As an adjunctive therapy for heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease
3 Vyvgart efgartigimod alfa-fcab 12/17/2021 Myasthenia gravis treatment
4 Tezspire tezepelumab-ekko 12/17/2021 As a maintenance treatment for severe asthma.
5 Cytalux pafolacianine 11/29/2021 To aid in the detection of ovarian cancer lesions         
6 Livtencity maribavir 11/23/2021 For treatment of cytomegalovirus (CMV) infection/disease after a transplant that does not respond to existing antiviral medication (with or without genetic changes that create resistance).
7 Voxzogo vosoritide 11/19/2021 To aid in the growth of children aged 5 and up who have achondroplasia and open epiphyses.
8 Besremi ropeginterferon alfa-2b-njft 11/12/2021 For treating polycythemia vera, a blood disorder characterised by an excess of red blood cells.
9 Scemblix asciminib 10/29/2021 To address chronic myeloid leukaemia using the Philadelphia chromosome that fits certain parameters.
10 Tavneos avacopan 10/7/2021 In combination with normal therapy, including glucocorticoids, to treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis).
11 Livmarli maralixibat 9/29/2021 To alleviate Alagille syndrome-related cholestatic pruritus
12 Qulipta atogepant 9/28/2021 To avoid migraines that occur on a regular basis
13 Tivdak tisotumab vedotin-tftv 9/20/2021 For treating  recurrent or metastatic cervical cancer that has progressed during or following treatment.
14 Exkivity mobocertinib 9/15/2021 Using epidermal growth factor receptor exon 20 insertion mutations to treat locally progressed or metastatic non-small cell lung cancer
15 Skytrofa lonapegsomatropin-tcgd 8/25/2021 To treat low stature caused by insufficient endogenous growth hormone production
16 Korsuva difelikefalin 8/23/2021 In certain individuals, to treat moderate-to-severe pruritus associated with chronic renal disease.
17 Welireg belzutifan 8/13/2021 Under certain circumstances, to treat von Hippel-Lindau disease
18 Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 To alleviate the symptoms of late-onset Pompe disease
19 Saphnelo anifrolumab-fnia 7/30/2021 Along with conventional medication, to treat moderate-to-severe systemic lupus erythematosus
20 Bylvay odevixibat 7/20/2021 To cure pruritus
21 Rezurock belumosudil 7/16/2021 For treating chronic graft-versus-host disease after at least two lines of systemic treatment have failed.
22 fexinidazole fexinidazole 7/16/2021 For the treatment of  human African trypanosomiasis.
23 Kerendia finerenone 7/9/2021 To lower the risk of renal and cardiac problems in people with type 2 diabetes who have chronic kidney disease.
24 Rylaze asparaginase erwinia chrysanthemi (recombinant)-rywn 6/30/2021 As part of a chemotherapy treatment, for treating acute lymphoblastic leukaemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products
25 Aduhelm aducanumab-avwa 6/7/2021 Alzheimer’s disease treatment          
26 Brexafemme ibrexafungerp 6/1/2021 vulvovaginal candidiasis treatment
27 Lybalvi olanzapine and samidorphan 5/28/2021 To cure schizophrenia, as well as some features of bipolar I disorder.
28 Truseltiq infigratinib 5/28/2021 To treat patients with cholangiocarcinoma who meet certain requirements.
29 Lumakras sotorasib 5/28/2021 To cure types of non-small cell lung cancer       
30 Pylarify piflufolastat F 18 5/26/2021 To find lesions in prostate cancer that are positive for prostate-specific membrane antigen
31 Rybrevant amivantamab-vmjw 5/21/2021 To cure a specific type of non-small cell lung cancer (NSCLC)          
32 Empaveli pegcetacoplan 5/14/2021 For treating nocturnal hemoglobinuria that comes and goes.
33 Zynlonta loncastuximab tesirine-lpyl 4/23/2021 To heal relapsed or resistant large B-cell lymphoma in some cases
34 Jemperli dostarlimab-gxly 4/22/2021 To alleviate endometrial cancer          
35 Nextstellis drospirenone and estetrol 4/15/2021 Pregnancy prevention
36 Qelbree viloxazine 4/2/2021 Attention deficit hyperactivity disorder (ADHD) treatment
37 Zegalogue dasiglucagon 3/22/2021 For treating hypoglycemia that is severe
38 Ponvory ponesimod 3/18/2021 Relapsing forms of multiple sclerosis are treated with this drug
39 Fotivda tivozanib 3/10/2021 Renal cell carcinoma treatment
40 Azstarys serdexmethylphenidate and dexmethylphenidate 3/2/2021 Attention deficit hyperactivity disorder treatment
41 Pepaxto melphalan flufenamide 2/26/2021 Multiple myeloma that has relapsed or become resistant to treatment
42 Nulibry fosdenopterin 2/26/2021 To lower the risk of death in people who have a molybdenum cofactor deficit A type of person
43 Amondys 45 casimersen 2/25/2021 For treating Duchenne muscular dystrophy
44 Cosela trilacicilib 2/12/2021 To minimize myelosuppression caused by chemotherapy in patients with small cell lung cancer
45 Evkeeza evinacumab-dgnb 2/11/2021 Homozygous familial hypercholesterolemia treatment
46 Ukoniq umbralisib 2/5/2021 To cure marginal zone lymphoma and follicular lymphoma
47 Tepmetko tepotinib 2/3/2021 Non-small cell lung cancer treatment
48 Lupkynis voclosporin 1/22/2021 For the treatment of lupus nephr itis
49 Cabenuva cabotegravir and rilpivirine (co-packaged) 1/21/2021 To alleviate HIV
50 Verquvo vericiguat 1/19/2021 To decrease the cardiovascular mortality risk and chronic heart failure hospitalisation


  1. Novel Drug Approvals  for 2021. Created 01/06/2022
  2. Gail A. Van Norman. Accepted 10 March 2016.

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