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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2021
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2021

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat. 

Each year, CDER approves a wide range of new drugs and biological products: 

  • Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2021. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2021. 
  • Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. 

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. 

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 
49. Leqvio inclisiran 12/22/2021 To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy
48.  Vyvgart efgartigimod alfa-fcab 12/17/2021 To treat generalized myasthenia gravis
Press Release
47. Tezspire  tezepelumab-ekko 12/17/2021 To treat severe asthma as an add-on maintenance therapy 
46. Cytalux  pafolacianine 11/29/2021 To help identify ovarian cancer lesions 
Press Release
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
44. Voxzogo vosoritide 11/19/2021 To improve growth in children five years of age and older with achondroplasia and open epiphyses
Press Release
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
42. Scemblix asciminib 10/29/2021 To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria
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
40. Livmarli maralixibat 9/29/2021 To treat cholestatic pruritus associated with Alagille syndrome
39. Qulipta atogepant 9/28/2021 To prevent episodic migraines
38. Tivdak tisotumab vedotin-tftv 9/20/2021 To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
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
36. Skytrofa lonapegsomatropin-tcgd 8/25/2021 To treat short stature due to inadequate secretion of endogenous growth hormone
35. Korsuva difelikefalin 8/23/2021 To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations
34. Welireg belzutifan 8/13/2021 To treat von Hippel-Lindau disease under certain conditions 
33. Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 To treat late-onset Pompe disease
Press Release
32. Saphnelo anifrolumab-fnia 7/30/2021 To treat moderate-to severe systemic lupus erythematousus along with standard therapy
31. Bylvay odevixibat 7/20/2021 To treat pruritus
30. Rezurock belumosudil 7/16/2021 To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
29. fexinidazole fexinidazole 7/16/2021 To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense
28. Kerendia finerenone 7/9/2021 To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes
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
26. Aduhelm aducanumab-avwa 6/7/2021 To treat Alzheimer’s disease
Press Release
25. Brexafemme ibrexafungerp  6/1/2021 To treat vulvovaginal candidiasis 
24. Lybalvi olanzapine and samidorphan 5/28/2021 To treat schizophrenia and certain aspects of bipolar I disorder 
23. Truseltiq infigratinib 5/28/2021 To treat cholangiocarcinoma whose disease meets certain criteria
22. Lumakras sotorasib 5/28/2021 To treat types of non-small cell lung cancer 
Press Release 
21. Pylarify piflufolastat F 18  5/26/2021 To identify prostate-specific membrane antigen-positive lesions in prostate cancer
20. Rybrevant amivantamab-vmjw 5/21/2021 To treat a subset of non-small cell lung cancer
Press Release
19. Empaveli pegcetacoplan 5/14/2021 To treat paroxysmal nocturnal hemoglobinuria
18. Zynlonta loncastuximab tesirine-lpyl 4/23/2021 To treat certain types of relapsed or refractory large B-cell lymphoma
17. Jemperli dostarlimab-gxly 4/22/2021 To treat endometrial cancer
Press Release
16. Nextstellis drospirenone and estetrol  4/15/2021 To prevent pregnancy
15. Qelbree viloxazine 4/2/2021 To treat attention deficit hyperactivity disorder
14. Zegalogue dasiglucagon 3/22/2021 To treat severe hypoglycemia
13. Ponvory ponesimod 3/18/2021 To treat relapsing forms of multiple sclerosis
12. Fotivda tivozanib 3/10/2021 To treat renal cell carcinoma
11 Azstarys serdexmethylphenidate and
3/2/2021  To treat attention deficit hyperactivity disorder
10. Pepaxto melphalan flufenamide 2/26/2021 To treat relapsed or refractory multiple myeloma
9. Nulibry fosdenopterin 2/26/2021 To reduce the risk of mortality in molybdenum cofactor deficiency Type A
Press Release
8. Amondys 45 casimersen 2/25/2021 To treat Duchenne muscular dystrophy
Press Release
7. Cosela trilacicilib 2/12/2021 To mitigate chemotherapy-induced myelosuppression in small cell lung cancer
Press Release
6. Evkeeza evinacumab-dgnb 2/11/2021 To treat homozygous familial hypercholesterolemia
5. Ukoniq umbralisib 2/5/2021 To treat marginal zone lymphoma and follicular lymphoma
4. Tepmetko tepotinib 2/3/2021 To treat non-small cell lung cancer
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) .

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