FDA Approved Novel Drugs for 2020

by Global Pharmacovigilance Team
January 3, 2021
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FDA Approved Novel Drugs for 2020

What is Novel Drug?

A Novel Drug or a New Molecular Entity (NME) is an active, complex compound, which has not been previously approved by the FDA/EMA.

Every year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drugs and biological products.

In 2020, FDA’s CDRER approved 53 new drugs, approved as new molecular entities (NMEs) for new drug applications (NDAs) or as new therapeutic biologics in connection with Biologics Licence Applications (BLAs).

New Drug Applications are 41

Biologics License Applications are 12

Some of these products are innovative new products that have never been used clinically.

Here is a list of new molecular entities and new therapeutic biological products approved by the CDRE in 2020.

The list does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2020 by the Center for Biologics Evaluation and Research.

FDA Approved Novel Drugs for 2020

No.	Brand Name	Key Ingredient	Company Name	Approval	Approval Date	FDA-approved use
1	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	09 January 2020	To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)
2	Tepezza	teprotumumab-trbw	Horizon Therapeutics Ireland DAC	BLA	21 January 2020	To treat Thyroid eye disease
3	Tazverik	tazemetostat	Epizyme	NDA	23 January 2020	To treat epithelioid sarcoma
4	Pizensy	lactitol	Braintree Laboratories, Inc	NDA	12 February 2020	To treat chronic idiopathic constipation (CIC) in adults
5	Nexletol	bempedoic acid	Esperion Therapeutics, Inc	NDA	21 February 2020	To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
6	Vyepti	eptinezumab-jjmr	Lundbeck Seattle BioPharmaceuticals, Inc.	BLA	21 February 2020	For the preventive treatment of migraine in adults
7	Barhemsys	amisulpride	Acacia Pharma Ltd	NDA	26 February 2020	To help prevent nausea and vomiting after surgery
8	Nurtec ODT	rimegepant	Biohaven Pharmaceuticals	NDA	27 February 2020	To treat migraine
9	Sarclisa	isatuximab	Sanofi Aventis US LLC.	BLA	03 February 2020	To treat multiple myloma
10	Isturisa	osilodrostat	Novartis Pharmaceuticals Corporation	NDA	06 March 2020	To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease
11	Zeposia	ozanimod	Celgene Corporation	NDA	25 March 2020	To treat relapsing forms of multiple sclerosis
12	Koselugo	selumetinib	AstraZeneca	NDA	10 April 2020	To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves
13	Tukysa	tucatinib	Seattle Genetics, Inc	NDA	17 April 2020	To treat advanced unresectable or metastatic HER2-positive breast cancer
14	Pemazyre	pemigatinib	Incyte Corporation	NDA	17 April 2020	To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts
15	Trodelvy	sacituzumab govitecan-hziy	lmmunomedics, Inc	BLA	22 April 2020	To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease
16	Ongentys	opicapone	Neurocrine Biosciences, Inc	NDA	24 April 2020	To treat patients with Parkinson’s disease experiencing “off” episodes
17	Tabrecta	capmatinib	Novartis Pharmaceuticals Corporation	NDA	06 May 2020	To treat patients with non small cell lung cancer
18	Retevmo	selpercatinib	Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company	NDA	08 May 2020	To treat lung and thyroid cancers
19	Qinlock	ripretinib	Deciphera Pharmaceuticals, LLC	NDA	15 May 2020	To treat advanced gastrointestinal-stromal tumors
20	Cerianna	fluoroestrdiol F18	Zionexa-US Corporation	NDA	20 May 2020	Diagnostic imaging agent for certain patients with breast cancer
21	Artesunate	artesunate	Amivas, LLC	NDA	26 May 2020	To treat severe malaria
22	Tauvid	flortaucipir F18	Avid Radiopharmaceuticals, Inc	NDA	28 May 2020	Diagnostic agent for patients with Alzheimer’s disease
23	Uplizna	inebilizumab-cdon	Viela Bio	BLA	11 June 2020	To treat neuromyelitis optica spectrum disorder
24	Zepzelca	lurbinectedin	Pharma Mar USA, Inc.	NDA	15 June 2020	To treat metastatic small cell lung cancer
25	Dojolvi	triheptanoin	Ultragenyx Pharmaceutical Inc.	NDA	30 June 2020	To treat molecularly long-chain fatty acid oxidation disorders
26	Byfavo	remimazolam	Cosmo Technologies, Ltd.	NDA	02 July 2020	For sedation
27	Rukobia	fostemsavir	ViiV Healthcare Company	NDA	02 July 2020	To treat HIV
28	Inqovi	decitabine and cedazuridine	Astex Pharmaceuticals, Inc.	NDA	07 July 2020	To treat adult patients with myelodysplastic syndromes
29	Xeglyze	abametapir	Dr. Reddy’s Laboratories	NDA	24 July 2020	To treat head lice
30	Monjuvi	tafasitamab-cxix	MorphoSys US Inc	BLA	31 July 2020	To treat relapsed or refractory diffuse large B-cell lymphoma
31	Blenrep	belantamab mafodotin-blmf	GlaxoSmithKline Intellectual Property Development Ltd. England	BLA	05 August 2020	To treat multiple myeloma
32	Lampit	nifurtimox	Bayer HealthCare Pharmaceuticals, Inc.	NDA	06 August 2020	To treat Chagas disease in certain pediatric patients younger than age 18
33	Evrysdi	risdiplam	Genentech, Inc.	NDA	07 August 2020	To treat spinal muscular atrophy
34	Olinvyk	oliceridine	Trevena, Inc.	NDA	07 August 2020	To manage acute pain in certain adults
35	Viltepso	viltolarsen	Nippon Shinyaku Co., Ltd.	NDA	12 August 2020	To treat Duchenne muscular dystrophy
36	Enspryng	satralizumab-mwge	Genentech, Inc.	BLA	14 August 2020	To treat neuromyelitis optica spectrum disorder
37	Winlevi	clascoterone	Cassiopea SpA	NDA	26 August 2020	To treat acne
38	Sogroya	somapacitan-beco	Novo Nordisk Inc	BLA	28 August 2020	Growth hormone
39	Detectnet	copper Cu 64 dotatate injection	RadioMedix, Inc	NDA	03 September 2020	To help detect certain types of neuroendocrine tumors
40	Gavreto	pralsetinib	Blueprint Medicines Corporation	NDA	04 September 2020	To treat non-small lung cancer
41	Inmazeb	atoltivimab, maftivimab, and odesivimab-ebgn	Regeneron Pharmaceuticals, Inc	BLA	14 October 2020	To treat ebola virus
42	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	22 October 2020	To treat COVID-19
43	Zokinvy	lonafarnib	Eiger BioPharmaceuticals, Inc.	NDA	20 November 2020	To treat rare conditions related to premature aging
44	Oxlumo	lumasiran	Alnylam Pharmaceuticals, Inc	NDA	23 November 2020	To treat hyperoxaluria type 1
45	Imcivree	setmelanotide	Rhythm Pharmaceuticals, Inc.	NDA	25 November 2020	To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age
46	Danyelza	naxitamab-gqgk	Y-MABS THERAPEUTICS INC	BLA	25 November 2020	To treat high-risk refractory or relapsed neuroblastoma
47	Gallium 68 PSMA-11	Gallium 68 PSMA-11	UNIV CA LOS ANGELES	NDA	01 December 2020	For detection and localization of prostate cancer
48	Orladeyo	berotralstat	BioCryst Pharmaceuticals, Inc.	NDA	04 December 2020	To treat patients with hereditary angioedema
49	Klisyri	tirbanibulin	Athenex, Inc	NDA	14 December 2020	To treat actinic Keratosis of the face or scalp
50	Margenza	margetuximab (anti-HER2 mAb)	MacroGenics, Inc	NDA	16 December 2020	To treat HER2+ breast cancer
51	Orgovyx	relugolix	Myovant Sciences GmbH	NDA	18 December 2020	To treat advanced prostate cancer
52	Ebanga	ansuvimab-zykl	Ridgeback Biotherapeutics, LP.	BLA	21 December 2020	To treat ebola
53	Gemtesa	viberon	Urovant Sciences	NDA	23 December 2020	To treat overactive bladder