FDA Novel Drug Approvals for 2023

FDA Novel Drug Approvals for 2023

Innovative drugs often mean new treatment options for patients and advances in health care for the 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.

FDA Novel Drug Approvals for 2023

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date*
55.	Wainua	eplontersen	12/21/2023	To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
54.	Filsuvez	birch triterpenes	12/18/2023	To treat wounds associated with dystrophic and junctional epidermolysis bullosa
53.	Fabhalta	iptacopan	12/5/2023	To treat paroxysmal nocturnal hemoglobinuria
52.	Ogsiveo	nirogacestat	11/27/2023	To treat adults with progressing desmoid tumors who require systemic treatment
51.	Truqap	capivasertib	11/16/2023	To treat breast cancer that meets certain disease criteria
50.	Ryzneuta	efbemalenograstim alfa-vuxw	11/16/2023	To treat neutropenia
49.	Augtyro	repotrectinib	11/15/2023	To treat ROS1-positive non-small cell lung cancer
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
47.	Fruzaqla	fruquintinib	11/8/2023	To treat refractory, metastatic colorectal cancer
46.	Loqtorzi	toripalimab-tpzi	10/27/2023	To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies
45.	Omvoh	mirikizumab-mrkz	10/26/2023	To treat ulcerative colitis
44.	Agamree	vamorolone	10/26/2023	To treat Duchenne muscular dystrophy
43.	Bimzelx	bimekizumab	10/17/2023	To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
42.	Zilbrysq	zilucoplan	10/17/2023	To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
41.	Velsipity	etrasimod	10/12/2023	To treat moderately to severely active ulcerative colitis in adults
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
39.	Pombiliti	cipaglucosidase alfa-atga	9/28/2023	To treat late-onset Pompe disease
38.	Exxua	gepirone	9/22/2023	To treat major depressive disorder
37.	Ojjaara	momelotinib	9/15/2023	To treat intermediate or high-risk myelofibrosis in adults with anemia
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
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
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
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
32.	Talvey	talquetamab-tgvs	8/9/2023	To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies
31.	Izervay	avacincaptad pegol	8/4/2023	To treat geographic atrophy secondary to age-related macular degeneration
30.	Zurzuvae	zuranolone	8/4/2023	To treat postpartum depression Press Release
29.	Xdemvy	lotilaner	7/25/2023	To treat Demodex blepharitis
28.	Vanflyta	quizartinib	7/20/2023	To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
27.	Beyfortus	nirsevimab-alip	7/17/2023	To prevent respiratory syncytial virus (RSV) lower respiratory tract disease Press Release
26.	Ngenla	somatrogon-ghla	6/27/2023	To treat growth failure due to inadequate secretion of endogenous growth hormone
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
24.	Litfulo	ritlecitinib	6/23/2023	To treat severely patchy hair loss
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
22.	Inpefa	sotagliflozin	5/26/2023	To treat heart failure
21.	Posluma	flotufolastat F 18	5/25/2023	To use with positron emission tomography imaging in certain patients with prostate cancer
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
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
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
17.	Miebo	perfluorhexyloctane	5/18/2023	To treat signs and symptoms of dry eye disease
16.	Veozah	fezolinetant	5/12/2023	To treat moderate to severe hot flashes caused by menopause Press Release
15.	Elfabrio	pegunigalsidase alfa-iwxj	5/9/2023	To treat confirmed Fabry disease
14.	Qalsody	tofersen	4/25/2023	To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation
13.	Joenja	leniolisib	3/24/2023	To treat activated phosphoinositide 3-kinase delta syndrome
12.	Rezzayo	rezafungin	3/22/2023	To treat candidemia and invasive candidiasis
11.	Zynyz	retifanlimab-dlwr	3/22/2023	To treat metastatic or recurrent locally advanced Merkel cell carcinoma
10.	Daybue	trofinetide	3/10/2023	To treat Rett syndrome
9.	Zavzpret	zavegepant	3/9/2023	To treat migraine
8.	Skyclarys	omaveloxolone	2/28/2023	To treat Friedrich’s ataxia
7.	Filspari	sparsentan	2/17/2023	To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
6.	Lamzede	velmanase alfa-tycv	2/16/2023	To treat non-central nervous system manifestations of alpha-mannosidosis
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
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
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
2.	Brenzavvy	bexagliflozin	1/20/2023	To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
1.	Leqembi	lecanemab-irmb	1/6/2023	To treat Alzheimer’s disease