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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2023
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2023

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


1/6/2023 To treat Alzheimer’s disease
Press Release
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 
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
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
6. Lamzede velmanase alfa-tycv 2/16/2023 To treat non-central nervous system manifestations of alpha-mannosidosis
7. Filspari sparsentan 2/17/2023 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
8. Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia
9. Zavzpret zavegepant 3/9/2023 To treat migraine
10. Daybue trofinetide 3/10/2023 To treat Rett syndrome
11. Zynyz retifanlimab-dlwr 3/22/2023 To treat metastatic or recurrent locally advanced Merkel cell carcinoma
12. Rezzayo rezafungin 3/22/2023 To treat candidemia and invasive candidiasis
13. Joenja leniolisib 3/24/2023 To treat activated phosphoinositide 3-kinase delta syndrome
14. Qalsody tofersen 4/25/2023 To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation
15. Elfabrio pegunigalsidase alfa-iwxj 5/9/2023 To treat confirmed Fabry disease
16. Veozah fezolinetant 5/12/2023 To treat moderate to severe hot flashes caused by menopause
Press Release
17. Miebo perfluorhexyloctane 5/18/2023 To treat signs and symptoms of dry eye disease
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
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

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
21. Posluma flotufolastat F 18 5/25/2023 To use with positron emission tomography imaging in certain patients with prostate cancer
22. Inpefa sotagliflozin 5/26/2023

​To treat heart failure 

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
24. Litfulo ritlecitinib 6/23/2023 To treat severely patchy hair loss
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
26. Ngenla somatrogon-ghla 6/27/2023 To treat growth failure due to inadequate secretion of endogenous growth hormone
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
29. Xdemvy lotilaner 7/25/2023 To treat Demodex blepharitis
30. Zurzuvae zuranolone 8/4/2023 To treat postpartum depression 
Press Release
31. Izervay avacincaptad pegol 8/4/2023 To treat geographic atrophy secondary to age-related macular degeneration
32. Talvey talquetamab-tgvs 8/9/2023 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies
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
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
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
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
37. Ojjaara momelotinib 9/15/2023 To treat intermediate or high-risk myelofibrosis in adults with anemia
38. Exxua gepirone 9/22/2023 To treat major depressive disorder
39. Pombiliti cipaglucosidase alfa-atga 9/28/2023 To treat late-onset Pompe disease
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
41. Velsipity etrasimod 10/12/2023 To treat moderately to severely active ulcerative colitis in adults
42. Zilbrysq zilucoplan 10/17/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
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
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
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
49. Augtyro repotrectinib 11/15/2023 To treat ROS1-positive non-small cell lung cancer
50. Ryzneuta efbemalenograstim alfa-vuxw 11/16/2023 To treat neutropenia
51. Truqap capivasertib 11/16/2023 To treat breast cancer that meets certain disease criteria
52. Ogsiveo nirogacestat 11/27/2023 To treat adults with progressing desmoid tumors who require systemic treatment
53. Fabhalta  iptacopan 12/5/2023 To treat paroxysmal nocturnal hemoglobinuria
54. Filsuvez birch triterpenes 12/18/2023 To treat wounds associated with dystrophic and junctional epidermolysis bullosa
55. 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).

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