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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

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With 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, CDER provides scientific and regulatory advice needed to bring new therapies to market.

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.

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

  • Some of these products are innovative new products that never have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2021. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2021 by the Center for Biologics Evaluation and Research.
  • 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 have not been approved by FDA previously, 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 have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. 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 TFDA-approved use on approval date*
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
dexmethylphenidate
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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