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* |
|---|---|---|---|---|
| 51. | Adbry | tralokinumab-ldrm | 12/27/2021 | To treat moderate-to-severe atopic dermatitis |
| 50. | Leqvio | inclisiran | 12/22/2021 | To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy |
| 49. | Vyvgart | efgartigimod alfa-fcab | 12/17/2021 | To treat generalized myasthenia gravis Press Release |
| 48. | Tezspire | tezepelumab-ekko | 12/17/2021 | To treat severe asthma as an add-on maintenance therapy |
| 47. | Cytalux | pafolacianine | 11/29/2021 | To help identify ovarian cancer lesions Press Release |
| 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 |
| 45. | Voxzogo | vosoritide | 11/19/2021 | To improve growth in children five years of age and older with achondroplasia and open epiphyses Press Release |
| 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 |
| 43. | Scemblix | asciminib | 10/29/2021 | To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria |
| 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 |
| 40. | Qulipta | atogepant | 9/28/2021 | To prevent episodic migraines |
| 39. | Tivdak | tisotumab vedotin-tftv | 9/20/2021 | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy |
| 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 |
| 37. | Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | To treat short stature due to inadequate secretion of endogenous growth hormone |
| 36. | Korsuva | difelikefalin | 8/23/2021 | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations |
| 35. | Welireg | belzutifan | 8/13/2021 | To treat von Hippel-Lindau disease under certain conditions |
| 34. | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | To treat late-onset Pompe disease Press Release |
| 33. | Saphnelo | anifrolumab-fnia | 7/30/2021 | To treat moderate-to severe systemic lupus erythematousus along with standard therapy |
| 32. | Bylvay | odevixibat | 7/20/2021 | To treat pruritus |
| 31. | Rezurock | belumosudil | 7/16/2021 | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy |
| 30. | fexinidazole | fexinidazole | 7/16/2021 | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense |
| 29. | Kerendia | finerenone | 7/9/2021 | To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes |
| 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 |
| 27. | Aduhelm | aducanumab-avwa | 6/7/2021 | To treat Alzheimer’s disease Press Release |
| 26. | Brexafemme | ibrexafungerp | 6/1/2021 | To treat vulvovaginal candidiasis |
| 25. | Lybalvi | olanzapine and samidorphan | 5/28/2021 | To treat schizophrenia and certain aspects of bipolar I disorder |
| 24. | Truseltiq | infigratinib | 5/28/2021 | To treat cholangiocarcinoma whose disease meets certain criteria |
| 23. | Lumakras | sotorasib | 5/28/2021 | To treat types of non-small cell lung cancer Press Release |
| 22. | Pylarify | piflufolastat F 18 | 5/26/2021 | To identify prostate-specific membrane antigen-positive lesions in prostate cancer |
| 21. | Rybrevant | amivantamab-vmjw | 5/21/2021 | To treat a subset of non-small cell lung cancer Press Release |
| 20. | Empaveli | pegcetacoplan | 5/14/2021 | To treat paroxysmal nocturnal hemoglobinuria |
| 19. | Azstarys | serdexmethylphenidate and dexmethylphenidate | 5/7/2021 | To treat attention deficit hyperactivity disorder Drug Trials Snapshots |
| 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 Drug Trials Snapshots |
| 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 Drug Trials Snapshots |
| 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) .