FDA Novel Drug Approvals in 2023

FDA Novel Drug Approvals

Published January 1st, 2023

Detected March 13th, 2026

Summary

The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.

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What changed

The FDA has published a notice detailing the 55 novel drugs approved by its Center for Drug Evaluation and Research (CDER) in 2023. These drugs are defined as new molecular entities never before approved or marketed in the U.S. The notice includes a table listing each drug, its active ingredient, approval date, and its FDA-approved use at the time of approval, along with links to further information such as drug labels and press releases.

This document serves as an informational summary of the FDA's drug approval activities for the year. While it does not impose new regulatory requirements or deadlines, it provides valuable insight into the types of therapies being advanced and approved. Pharmaceutical companies and drug manufacturers can use this information to understand the current landscape of drug innovation and regulatory focus areas. Compliance officers should note the specific uses and approval dates for context in their ongoing monitoring of pharmaceutical developments.

Source document (simplified)

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).