Novel Drug Approvals for 2023
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 |
| 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 |
| 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 Snapshots |
| 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 Drug Trials Snapshot |
| 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 Drug Trials Snapshots |
| 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 Drug Trails 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 |
| 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 |
| 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 |
| 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 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 |
| 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 Drug Trials Snapshot |
| 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 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 |
| 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 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 |
| 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 |
| 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 |
| 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).