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                New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

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          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Novel Drug Approvals for 2023New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products Novel Drug Approvals for 2023
  
  	
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Advancing Health Through Innovation: New Drug Therapy Approvals 2023 (PDF - 2 MB)

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 2023. 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 2023.
	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*1.
			Leqembi
			lecanemab-irmb
			1/6/2023
			To treat Alzheimer’s diseasePress Release2.
			Brenzavvy
			bexagliflozin
			1/20/2023
			To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise3.
			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 inhibitor4.
			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 therapy5.
			Jesduvroq
			daprodustat
			2/1/2023
			To treat anemia caused by chronic kidney disease for adults on dialysis for at least four monthsPress Release6.
			Lamzede
			velmanase alfa-tycv
			2/16/2023
			To treat non-central nervous system manifestations of alpha-mannosidosis7.
			Filspari
			sparsentan
			2/17/2023
			To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression8.
			Skyclarys
			omaveloxolone
			2/28/2023
			To treat Friedrich’s ataxia9.
			Zavzpret
			zavegepant
			3/9/2023
			To treat migraine10.
			Daybue
			trofinetide
			3/10/2023
			To treat Rett syndrome11.
			Zynyz
			retifanlimab-dlwr
			3/22/2023
			To treat metastatic or recurrent locally advanced Merkel cell carcinoma12.
			Rezzayo
			rezafungin
			3/22/2023
			To treat candidemia and invasive candidiasis13.
			Joenja
			leniolisib
			3/24/2023
			To treat activated phosphoinositide 3-kinase delta syndrome14.
			Qalsody
			tofersen
			4/25/2023
			To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation15.
			Elfabrio
			pegunigalsidase alfa-iwxj
			5/9/2023
			To treat confirmed Fabry disease16.
			Veozah
			fezolinetant
			5/12/2023
			To treat moderate to severe hot flashes caused by menopausePress Release17.
			Miebo
			perfluorhexyloctane
			5/18/2023
			To treat signs and symptoms of dry eye disease18.
			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 therapy19.
			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 Release20.
			Paxlovid
			nirmatrelvir, ritonavir
			5/25/2023
			To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19Press Release21.
			Posluma
			flotufolastat F 18
			5/25/2023
			To use with positron emission tomography imaging in certain patients with prostate cancer22.
			Inpefa
			sotagliflozin
			5/26/2023
			​To treat heart failure23.
			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 therapy24.
			Litfulo
			ritlecitinib
			6/23/2023
			To treat severely patchy hair loss25.
			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-positive26.
			Ngenla
			somatrogon-ghla
			6/27/2023
			To treat growth failure due to inadequate secretion of endogenous growth hormone27.
			Beyfortus
			nirsevimab-alip
			7/17/2023
			To prevent respiratory syncytial virus (RSV) lower respiratory tract diseasePress Release28.
			Vanflyta
			quizartinib
			7/20/2023
			To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria29.
			Xdemvy
			lotilaner
			7/25/2023
			To treat Demodex blepharitis30.
			Zurzuvae
			zuranolone
			8/4/2023
			To treat postpartum depression Press Release31.
			Izervay
			avacincaptad pegol
			8/4/2023
			To treat geographic atrophy secondary to age-related macular degeneration32.
			Talvey
			talquetamab-tgvs
			8/9/2023
			To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies33.
			Elrexfio
			elranatamab-bcmm
			8/14/2023
			To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy34.
			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 progressiva35.
			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 disease36.
			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 myeloma37.
			Ojjaara
			momelotinib
			9/15/2023
			To treat intermediate or high-risk myelofibrosis in adults with anemia38.
			Exxua
			gepirone
			9/22/2023
			To treat major depressive disorder39.
			Pombiliti
			cipaglucosidase alfa-atga
			9/28/2023
			To treat late-onset Pompe disease40.
			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 function41.
			Velsipity
			etrasimod
			10/12/2023
			To treat moderately to severely active ulcerative colitis in adults42.
			Zilbrysq
			zilucoplan
			10/17/2023
			To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive43.
			Bimzelx
			bimekizumab
			10/17/2023
			To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy44.
			Agamree
			vamorolone
			10/26/2023
			To treat Duchenne muscular dystrophy45.
			Omvoh
			mirikizumab-mrkz
			10/26/2023
			To treat ulcerative colitis46.
			Loqtorzi
			toripalimab-tpzi
			10/27/2023
			To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies47.
			Fruzaqla
			fruquintinib
			11/8/2023
			To treat refractory, metastatic colorectal cancer48.
			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 catheter49.
			Augtyro
			repotrectinib
			11/15/2023
			To treat ROS1-positive non-small cell lung cancer50.
			Ryzneuta
			efbemalenograstim alfa-vuxw
			11/16/2023
			To treat neutropenia51.
			Truqap
			capivasertib
			11/16/2023
			To treat breast cancer that meets certain disease criteria52.
			Ogsiveo
			nirogacestat
			11/27/2023
			To treat adults with progressing desmoid tumors who require systemic treatment53.
			Fabhalta
			iptacopan
			12/5/2023
			To treat paroxysmal nocturnal hemoglobinuria54.
			Filsuvez
			birch triterpenes
			12/18/2023
			To treat wounds associated with dystrophic and junctional epidermolysis bullosa55.
			Wainua
			eplontersen
			12/21/2023
			To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis

*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).

                                                                                  Content current as of:
      01/16/2024
              
              
Regulated Product(s)
		 DrugsNew Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

          
                        Novel Drug Approvals for 2024
          Novel Drug Approvals for 2023
          Novel Drug Approvals for 2022
          Novel Drug Approvals for 2021
          Novel Drug Approvals for 2020
          Novel Drug Approvals for 2019
          Novel Drug Approvals for 2018
          Novel Drug Approvals for 2017
          Novel Drug Approvals for 2016
          Novel Drug Approvals for 2015
 
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