Novel Drug Approvals for 2024
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 2024
The table below is a running list of CDER’s novel drugs approvals for 2024.
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 43. | Iomervu | iomeprol | 11/27/2024 | For use as a radiographic contrast agent |
| 42. | Rapiblyk | landiolol | 11/22/2024 | To treat supraventricular tachycardia |
| 41. | Attruby | acoramidis | 11/22/2024 | To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis |
| 40. | Ziihera | zanidatamab-hrii | 11/20/2024 | To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer |
| 39. | Revuforj | revumenib | 11/15/2024 | To treat relapsed or refractory acute leukemia |
| 38. | Orlynvah | sulopenem etzadroxil, probenecid | 10/25/2024 | To treat uncomplicated urinary tract infections (uUTI) |
| 37. | Vyloy | zolbetuximab-clzb | 10/18/2024 | To treat gastric or gastroesophageal junction adenocarcinoma |
| 36. | Hympavzi | marstacimab-hncq | 10/11/2024 | To prevent or reduce bleeding episodes related to hemophilia A or B Press Release |
| 35. | Itovebi | inavolisib | 10/10/2024 | To treat locally advanced or metastatic breast cancer |
| 34. | Flyrcado | flurpiridaz F 18 | 9/27/2024 | A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction |
| 33. | Cobenfy | xanomeline and trospium chloride | 9/26/2024 | To treat schizophrenia Press Release |
| 32. | Aqneursa | levacetylleucine | 9/24/2024 | To treat Niemann-Pick disease type C Press Release |
| 31. | Miplyffa | arimoclomol | 9/20/2024 | To treat Niemann-Pick disease type C Press Release |
| 30. | Ebglyss | lebrikizumab-lbkz | 9/13/2024 | To treat moderate-to-severe atopic dermatitis Drug Trials Snapshot |
| 29. | Lazcluze | lazertinib | 8/19/2024 | To treat non-small cell lung cancer |
| 28. | Niktimvo | axatilimab-csfr | 8/14/2024 | To treat chronic graft-versus-host disease (cGVHD) |
| 27. | Livdelzi | seladelpar | 8/14/2024 | To treat primary biliary cholangitis (PBC) Drug Trials Snapshot |
| 26. | Nemluvio | nemolizumab-ilto | 8/12/2024 | To treat prurigo nodularis Drug Trials Snapshot |
| 25. | Yorvipath | palopegteriparatide | 8/9/2024 | To treat hypoparathyroidism Drug Trials Snapshot |
| 24. | Voranigo | vorasidenib | 8/6/2024 | To treat Grade 2 astrocytoma or oligodendroglioma |
| 23. | Leqselvi | deuruxolitinib | 7/25/2024 | To treat severe alopecia areata Drug Trials Snapshot |
| 22. | Kisunla | donanemab-azbt | 7/2/2024 |
To treat Alzheimer’s disease |
| 21. | Ohtuvayre | ensifentrine | 6/26/2024 | To treat chronic obstructive pulmonary disease Drug Trials Snapshot |
| 20. | Piasky | crovalimab-akkz | 6/20/2024 | To treat paroxysmal nocturnal hemoglobinuria Drug Trials Snapshot |
| 19. | Sofdra | sofpironium | 6/18/2024 | To treat primary axillary hyperhidrosis Drug Trials Snapshot |
| 18. | Iqirvo | elafibranor | 6/10/2024 | To treat primary biliary cholangitis in combination with ursodeoxycholic acid Drug Trials Snapshot |
| 17. | Rytelo | imetelstat | 6/6/2024 | To treat low- to intermediate-1 risk myelodysplastic syndromes Drug Trials Snapshot |
| 16. | Imdelltra | tarlatamab-dlle | 5/16/2024 | To treat extensive stage small cell lung cancer Drug Trials Snapshot |
| 15. | Xolremdi | mavorixafor | 4/26/2024 | To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) Drug Trials Snapshot |
| 14. | Ojemda | tovorafenib | 4/23/2024 | To treat relapsed or refractory pediatric low-grade glioma Drug Trials Snapshot |
| 13. | Anktiva | nogapendekin alfa inbakicept-pmln | 4/22/2024 | To treat bladder cancer Drug Trials Snapshot |
| 12. | Lumisight | pegulicianine | 4/17/2024 | To use as an optical imaging agent for the detection of cancerous tissue Drug Trials Snapshot |
| 11. | Zevtera | ceftobiprole medocaril sodium | 4/3/2024 |
To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia |
| 10. | Voydeya | danicopan | 3/29/2024 | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria Drug Trials Snapshot |
| 9. | Vafseo | vadadustat | 3/27/2024 | To treat anemia due to chronic kidney disease Drug Trials Snapshot |
| 8. | Winrevair | sotatercept-csrk | 3/26/2024 | To treat pulmonary arterial hypertension Drug Trials Snapshot |
| 7. | Duvyzat | givinostat | 3/21/2024 | To treat Duchenne muscular dystrophy in individuals aged 6 years and older Press Release Drug Trials Snapshot |
| 6. | Tryvio | aprocitentan | 3/19/2024 | To treat hypertension Drug Trials Snapshot |
| 5. | Rezdiffra | resmetirom | 3/14/2024 |
To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring |
| 4. | Tevimbra | tislelizumab-jsgr | 3/13/2024 | To treat unresectable or metastatic esophageal squamous cell carcinoma Drug Trials Snapshot |
| 3. | Letybo | letibotulinumtoxinA-wlbg | 2/29/2024 | To temporarily improve the appearance of moderate-to-severe glabellar lines Drug Trials Snapshot |
| 2. | Exblifep | cefepime, enmetazobactam | 2/22/2024 | To treat complicated urinary tract infections Drug Trials Snapshot |
| 1. | Zelsuvmi | berdazimer | 1/5/2024 | To treat molluscum contagiosum 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).