Novel Drug Approvals for 2021
Helping Guide the Way for New Medicines
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.
A Wide Range of Products
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 approved by CDER and organized by calendar year. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved 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.
New Molecular Entities (NMEs)
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* |
|---|---|---|---|---|
| 51. | Adbry | tralokinumab-ldrm | 12/27/2021 | To treat moderate-to-severe atopic dermatitis Drug Trials Snapshot |
| 50. | Leqvio | inclisiran | 12/22/2021 | To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy Drug Trials Snapshot |
| 49. | Vyvgart | efgartigimod alfa-fcab | 12/17/2021 | To treat generalized myasthenia gravis Press Release Drug Trials Snapshot |
| 48. | Tezspire | tezepelumab-ekko | 12/17/2021 | To treat severe asthma as an add-on maintenance therapy Drug Trials Snapshot |
| 47. | Cytalux | pafolacianine | 11/29/2021 | To help identify ovarian cancer lesions Press Release Drug Trials Snapshot |
| 46. | 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 Drug Trials Snapshot |
| 45. | Voxzogo | vosoritide | 11/19/2021 | To improve growth in children five years of age and older with achondroplasia and open epiphyses Press Release Drug Trials Snapshot |
| 44 | 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 Drug Trials Snapshot |
| 43. | Scemblix | asciminib | 10/29/2021 | To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria Drug Trials Snapshot |
| 42. | 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 |
| 41. | Livmarli | maralixibat | 9/29/2021 | To treat cholestatic pruritus associated with Alagille syndrome Drug Trial Snapshot |
| 40. | Qulipta | atogepant | 9/28/2021 | To prevent episodic migraines Drug Trial Snapshot |
| 39. | Tivdak | tisotumab vedotin-tftv | 9/20/2021 | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy Drug Trial Snapshot |
| 38. | 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 Drug Trials Snapshot |
| 37. | Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | To treat short stature due to inadequate secretion of endogenous growth hormone Drug Trial Snapshot |
| 36. | Korsuva | difelikefalin | 8/23/2021 | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations Drug Trials Snapshot |
| 35. | Welireg | belzutifan | 8/13/2021 | To treat von Hippel-Lindau disease under certain conditions Drug Trials Snapshot |
| 34. | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | To treat late-onset Pompe disease Press Release Drug Trials Snapshot |
| 33. | Saphnelo | anifrolumab-fnia | 7/30/2021 | To treat moderate-to severe systemic lupus erythematousus along with standard therapy Drug Trials Snapshots |
| 32. | Bylvay | odevixibat | 7/20/2021 | To treat pruritus Drug Trials Snapshots |
| 31. | Rezurock | belumosudil | 7/16/2021 | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy Drug Trials Snapshot |
| 30. | Fexinidazole | fexinidazole | 7/16/2021 | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense Drug Trials Snapshot |
| 29. | Kerendia | finerenone | 7/9/2021 | To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes Drug Trials Snapshot |
| 28. | 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 Drug Trials Snapshots |
| 27. | Aduhelm | aducanumab-avwa | 6/7/2021 | To treat Alzheimer’s disease Press Release Drug Trials Snapshots |
| 26. | Brexafemme | ibrexafungerp | 6/1/2021 | To treat vulvovaginal candidiasis Drug Trials Snapshots |
| 25. | Lybalvi | olanzapine and samidorphan | 5/28/2021 | To treat schizophrenia and certain aspects of bipolar I disorder Drug Trials Snapshot |
| 24. | Truseltiq | infigratinib | 5/28/2021 | To treat cholangiocarcinoma whose disease meets certain criteria Drug Trials Snapshot |
| 23. | Lumakras | sotorasib | 5/28/2021 | To treat types of non-small cell lung cancer Press Release Drug Trials Snapshot |
| 22. | Pylarify | piflufolastat F 18 | 5/26/2021 | To identify prostate-specific membrane antigen-positive lesions in prostate cancer Drug Trials Snapshot |
| 21. | Rybrevant | amivantamab-vmjw | 5/21/2021 | To treat a subset of non-small cell lung cancer Drug Trials Snapshot Press Release |
| 20. | Empaveli | pegcetacoplan | 5/14/2021 | To treat paroxysmal nocturnal hemoglobinuria Drug Trials Snapshot |
| 19. | Azstarys | serdexmethylphenidate and dexmethylphenidate | 5/7/2021 | To treat attention deficit hyperactivity disorder Drug Trials Snapshot |
| 18. | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | To treat certain types of relapsed or refractory large B-cell lymphoma Drug Trials Snapshot |
| 17. | Jemperli | dostarlimab-gxly | 4/22/2021 | To treat endometrial cancer Press Release Drug Trials Snapshot |
| 16. | Nextstellis | drospirenone and estetrol | 4/15/2021 | To prevent pregnancy Drug Trials Snapshot |
| 15. | Qelbree | viloxazine | 4/2/2021 | To treat attention deficit hyperactivity disorder Drug Trials Snapshot |
| 14. | Zegalogue | dasiglucagon | 3/22/2021 | To treat severe hypoglycemia Drug Trials Snapshot |
| 13. | Ponvory | ponesimod | 3/18/2021 | To treat relapsing forms of multiple sclerosis Drug Trials Snapshot |
| 12. | Fotivda | tivozanib | 3/10/2021 | To treat renal cell carcinoma Drug Trials Snapshot |
| 11 | Azstarys | serdexmethylphenidate and dexmethylphenidate |
3/2/2021 | To treat attention deficit hyperactivity disorder Drug Trials Snapshot |
| 10. | Pepaxto | melphalan flufenamide | 2/26/2021 | To treat relapsed or refractory multiple myeloma Drug Trials Snapshot |
| 9. | Nulibry | fosdenopterin | 2/26/2021 | To reduce the risk of mortality in molybdenum cofactor deficiency Type A Press Release Drug Trials Snapshot |
| 8. | Amondys 45 | casimersen | 2/25/2021 | To treat Duchenne muscular dystrophy Press Release Drug Trials Snapshot |
| 7. | Cosela | trilacicilib | 2/12/2021 | To mitigate chemotherapy-induced myelosuppression in small cell lung cancer Press Release Drug Trials Snapshot |
| 6. | Evkeeza | evinacumab-dgnb | 2/11/2021 | To treat homozygous familial hypercholesterolemia Drug Trials Snapshot |
| 5. | Ukoniq | umbralisib | 2/5/2021 | To treat marginal zone lymphoma and follicular lymphoma Drug Trials Snapshot |
| 4. | Tepmetko | tepotinib | 2/3/2021 | To treat non-small cell lung cancer Drug Trials Snapshot |
| 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) .