US FDA’s Center for Drug Evaluation and Research (CDER) – Novel Drug Approvals for 2021

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	FDA-approved use on approval date*
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 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).

Access more Info: ChemRoboticsPharma.com (Pharmaceutical Database) & ChemRobotics.com (Agrochemical Database)