Novel Drug Approvals for 2023

Advancing Health Through Innovation: New Drug Therapy Approvals 2023 (PDF - 2 MB)

What are "Novel" Drugs?

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.

FDA Novel Drug Therapy Approvals for 2023

In 2023, CDER approved 55 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as expanding the use or patient population of previously approved drugs.
CDER’s novel drug approvals for 2023 are listed below. For more information, download the report Advancing Health Through Innovation: New Drug Therapy Approvals for 2023. 

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date*
1.	Leqembi	lecanemab-irmb	1/6/2023	To treat Alzheimer’s disease Press Release Drug Trials Snapshot
2.	Brenzavvy	bexagliflozin	1/20/2023	To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise Drug Trials Snapshot
3.	Jaypirca	pirtobrutinib	1/27/2023	To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor Drug Trials Snapshot
4.	Orserdu	elacestrant	1/27/2023	To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy Drug Trials Snapshot
5.	Jesduvroq	daprodustat	2/1/2023	To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months Press Release Drug Trials Snapshot
6.	Lamzede	velmanase alfa-tycv	2/16/2023	To treat non-central nervous system manifestations of alpha-mannosidosis Drug Trials Snapshot
7.	Filspari	sparsentan	2/17/2023	To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression Drug Trials Snapshot
8.	Skyclarys	omaveloxolone	2/28/2023	To treat Friedrich’s ataxia Drug Trials Snapshot
9.	Zavzpret	zavegepant	3/9/2023	To treat migraine Drug Trails Snapshot
10.	Daybue	trofinetide	3/10/2023	To treat Rett syndrome Drug Trials Snapshot
11.	Zynyz	retifanlimab-dlwr	3/22/2023	To treat metastatic or recurrent locally advanced Merkel cell carcinoma Drug Trials Snapshot
12.	Rezzayo	rezafungin	3/22/2023	To treat candidemia and invasive candidiasis Drug Trials Snapshot
13.	Joenja	leniolisib	3/24/2023	To treat activated phosphoinositide 3-kinase delta syndrome Drug Trials Snapshot
14.	Qalsody	tofersen	4/25/2023	To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation Drug Trials Snapshot
15.	Elfabrio	pegunigalsidase alfa-iwxj	5/9/2023	To treat confirmed Fabry disease Drug Trials Snapshot
16.	Veozah	fezolinetant	5/12/2023	To treat moderate to severe hot flashes caused by menopause Press Release Drug Trials Snapshot
17.	Miebo	perfluorhexyloctane	5/18/2023	To treat signs and symptoms of dry eye disease Drug Trials Snapshot
18.	Epkinly	epcoritamab-bysp	5/19/2023	To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy Drug Trials Snapshots
19.	Xacduro	sulbactam, durlobactam	5/23/2023	To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex Press Release Drug Trials Snapshots
20.	Paxlovid	nirmatrelvir, ritonavir	5/25/2023	To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 Press Release Drug Trials Snapshot
21.	Posluma	flotufolastat F 18	5/25/2023	To use with positron emission tomography imaging in certain patients with prostate cancer Drug Trials Snapshot
22.	Inpefa	sotagliflozin	5/26/2023	To treat heart failure Drug Trials Snapshot
23.	Columvi	glofitamab-gxbm	6/15/2023	To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy Drug Trials Snapshot
24.	Litfulo	ritlecitinib	6/23/2023	To treat severely patchy hair loss Drug Trials Snapshot
25.	Rystiggo	rozanolixizumab-noli	6/26/2023	To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive Drug Trials Snapshot
26.	Ngenla	somatrogon-ghla	6/27/2023	To treat growth failure due to inadequate secretion of endogenous growth hormone Drug Trials Snapshot
27.	Beyfortus	nirsevimab-alip	7/17/2023	To prevent respiratory syncytial virus (RSV) lower respiratory tract disease Press Release Drug Trials Snapshot
28.	Vanflyta	quizartinib	7/20/2023	To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria Drug Trials Snapshot
29.	Xdemvy	lotilaner	7/25/2023	To treat Demodex blepharitis Drug Trials Snapshot
30.	Zurzuvae	zuranolone	8/4/2023	To treat postpartum depression  Press Release Drug Trials Snapshot
31.	Izervay	avacincaptad pegol	8/4/2023	To treat geographic atrophy secondary to age-related macular degeneration Drug Trials Snapshots: IZERVAY
32.	Talvey	talquetamab-tgvs	8/9/2023	To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies Drug Trials Snapshot
33.	Elrexfio	elranatamab-bcmm	8/14/2023	To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy Drug Trials Snapshot
34.	Sohonos	palovarotene	8/16/2023	To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva Drug Trials Snapshot
35.	Veopoz	pozelimab-bbfg	8/18/2023	To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease Drug Trials Snapshot
36.	Aphexda	motixafortide	9/8/2023	To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma Drug Trials Snapshot
37.	Ojjaara	momelotinib	9/15/2023	To treat intermediate or high-risk myelofibrosis in adults with anemia Drug Trials Snapshot
38.	Exxua	gepirone	9/22/2023	To treat major depressive disorder Drug Trials Snapshot
39.	Pombiliti	cipaglucosidase alfa-atga	9/28/2023	To treat late-onset Pompe disease Drug Trials Snapshot
40.	Rivfloza	nedosiran	9/29/2023	To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function Drug Trials Snapshot
41.	Velsipity	etrasimod	10/12/2023	To treat moderately to severely active ulcerative colitis in adults Drug Trials Snapshot
42.	Zilbrysq	zilucoplan	10/17/2023	To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive Drug Trials Snapshot
43.	Bimzelx	bimekizumab	10/17/2023	To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Drug Trials Snapshot
44.	Agamree	vamorolone	10/26/2023	To treat Duchenne muscular dystrophy Drug Trials Snapshot
45.	Omvoh	mirikizumab-mrkz	10/26/2023	To treat ulcerative colitis Drug Trials Snapshot
46.	Loqtorzi	toripalimab-tpzi	10/27/2023	To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies
47.	Fruzaqla	fruquintinib	11/8/2023	To treat refractory, metastatic colorectal cancer Drug Trials Snapshot
48.	Defencath	taurolidine, heparin	11/15/2023	To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter Drug Trials Snapshot
49.	Augtyro	repotrectinib	11/15/2023	To treat ROS1-positive non-small cell lung cancer Drug Trials Snapshot
50.	Ryzneuta	efbemalenograstim alfa-vuxw	11/16/2023	To treat neutropenia Drug Trials Snapshot
51.	Truqap	capivasertib	11/16/2023	To treat breast cancer that meets certain disease criteria Drug Trials Snapshot
52.	Ogsiveo	nirogacestat	11/27/2023	To treat adults with progressing desmoid tumors who require systemic treatment Drug Trials Snapshot
53.	Fabhalta	iptacopan	12/5/2023	To treat paroxysmal nocturnal hemoglobinuria Drug Trials Snapshot
54.	Filsuvez	birch triterpenes	12/18/2023	To treat wounds associated with dystrophic and junctional epidermolysis bullosa Drug Trials Snapshot
55.	Wainua	eplontersen	12/21/2023	To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis 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 A-approved Prescribing Information (click on the Drug Name).