Food & Drug Administration Approved Drugs in 2021

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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 NameActive IngredientApproval DateFDA-approved use on approval date
1Adbrytralokinumab-ldrm12/27/2021Atopic dermatitis (mild-to-severe)
2Leqvioinclisiran12/22/2021As an adjunctive therapy for heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease
3Vyvgartefgartigimod alfa-fcab12/17/2021Myasthenia gravis treatment
4Tezspiretezepelumab-ekko12/17/2021As a maintenance treatment for severe asthma.
5Cytaluxpafolacianine11/29/2021To aid in the detection of ovarian cancer lesions         
6Livtencitymaribavir11/23/2021For 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).
7Voxzogovosoritide11/19/2021To aid in the growth of children aged 5 and up who have achondroplasia and open epiphyses.
8Besremiropeginterferon alfa-2b-njft11/12/2021For treating polycythemia vera, a blood disorder characterised by an excess of red blood cells.
9Scemblixasciminib10/29/2021To address chronic myeloid leukaemia using the Philadelphia chromosome that fits certain parameters.
10Tavneosavacopan10/7/2021In combination with normal therapy, including glucocorticoids, to treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis).
11Livmarlimaralixibat9/29/2021To alleviate Alagille syndrome-related cholestatic pruritus
12Quliptaatogepant9/28/2021To avoid migraines that occur on a regular basis
13Tivdaktisotumab vedotin-tftv9/20/2021For treating  recurrent or metastatic cervical cancer that has progressed during or following treatment.
14Exkivitymobocertinib9/15/2021Using epidermal growth factor receptor exon 20 insertion mutations to treat locally progressed or metastatic non-small cell lung cancer
15Skytrofalonapegsomatropin-tcgd8/25/2021To treat low stature caused by insufficient endogenous growth hormone production
16Korsuvadifelikefalin8/23/2021In certain individuals, to treat moderate-to-severe pruritus associated with chronic renal disease.
17Weliregbelzutifan8/13/2021Under certain circumstances, to treat von Hippel-Lindau disease
18Nexviazymeavalglucosidase alfa-ngpt8/6/2021To alleviate the symptoms of late-onset Pompe disease
19Saphneloanifrolumab-fnia7/30/2021Along with conventional medication, to treat moderate-to-severe systemic lupus erythematosus
20Bylvayodevixibat7/20/2021To cure pruritus
21Rezurockbelumosudil7/16/2021For treating chronic graft-versus-host disease after at least two lines of systemic treatment have failed.
22fexinidazolefexinidazole7/16/2021For the treatment of  human African trypanosomiasis.
23Kerendiafinerenone7/9/2021To lower the risk of renal and cardiac problems in people with type 2 diabetes who have chronic kidney disease.
24Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywn6/30/2021As part of a chemotherapy treatment, for treating acute lymphoblastic leukaemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products
25Aduhelmaducanumab-avwa6/7/2021Alzheimer’s disease treatment          
26Brexafemmeibrexafungerp6/1/2021vulvovaginal candidiasis treatment
27Lybalviolanzapine and samidorphan5/28/2021To cure schizophrenia, as well as some features of bipolar I disorder.
28Truseltiqinfigratinib5/28/2021To treat patients with cholangiocarcinoma who meet certain requirements.
29Lumakrassotorasib5/28/2021To cure types of non-small cell lung cancer       
30Pylarifypiflufolastat F 185/26/2021To find lesions in prostate cancer that are positive for prostate-specific membrane antigen
31Rybrevantamivantamab-vmjw5/21/2021To cure a specific type of non-small cell lung cancer (NSCLC)          
32Empavelipegcetacoplan5/14/2021For treating nocturnal hemoglobinuria that comes and goes.
33Zynlontaloncastuximab tesirine-lpyl4/23/2021To heal relapsed or resistant large B-cell lymphoma in some cases
34Jemperlidostarlimab-gxly4/22/2021To alleviate endometrial cancer          
35Nextstellisdrospirenone and estetrol4/15/2021Pregnancy prevention
36Qelbreeviloxazine4/2/2021Attention deficit hyperactivity disorder (ADHD) treatment
37Zegaloguedasiglucagon3/22/2021For treating hypoglycemia that is severe
38Ponvoryponesimod3/18/2021Relapsing forms of multiple sclerosis are treated with this drug
39Fotivdativozanib3/10/2021Renal cell carcinoma treatment
40Azstarysserdexmethylphenidate and dexmethylphenidate3/2/2021Attention deficit hyperactivity disorder treatment
41Pepaxtomelphalan flufenamide2/26/2021Multiple myeloma that has relapsed or become resistant to treatment
42Nulibryfosdenopterin2/26/2021To lower the risk of death in people who have a molybdenum cofactor deficit A type of person
43Amondys 45casimersen2/25/2021For treating Duchenne muscular dystrophy
44Coselatrilacicilib2/12/2021To minimize myelosuppression caused by chemotherapy in patients with small cell lung cancer
45Evkeezaevinacumab-dgnb2/11/2021Homozygous familial hypercholesterolemia treatment
46Ukoniqumbralisib2/5/2021To cure marginal zone lymphoma and follicular lymphoma
47Tepmetkotepotinib2/3/2021Non-small cell lung cancer treatment
48Lupkynisvoclosporin1/22/2021For the treatment of lupus nephritis
49Cabenuvacabotegravir and rilpivirine (co-packaged)1/21/2021To alleviate HIV
50Verquvovericiguat1/19/2021To decrease the cardiovascular mortality risk and chronic heart failure hospitalisation

References:

  1. Novel Drug Approvals  for 2021. Created 01/06/2022 https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
  2. Gail A. Van Norman. Accepted 10 March 2016. https://www.sciencedirect.com/science/article/pii/S2452302X1600036X
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