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* |
|---|---|---|---|---|
| 22. | Kisunla | donanemab-azbt | 7/2/2024 | To treat Alzheimer’s disease |
| 21. | Ohtuvayre | ensifentrine | 6/26/2024 | To treat chronic obstructive pulmonary disease |
| 20. | Piasky | crovalimab-akkz | 6/20/2024 | To treat paroxysmal nocturnal hemoglobinuria |
| 19. | Sofdra | sofpironium | 6/18/2024 | To treat primary axillary hyperhidrosis |
| 18. | Iqirvo | elafibranor | 6/10/2024 | To treat primary biliary cholangitis in combination with ursodeoxycholic acid |
| 17. | Rytelo | imetelstat | 6/6/2024 | To treat low- to intermediate-1 risk myelodysplastic syndromes |
| 16. | Imdelltra | tarlatamab-dlle | 5/16/2024 | To treat extensive stage small cell lung cancer |
| 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 |
| 13. | Anktiva | nogapendekin alfa inbakicept-pmln | 4/22/2024 | To treat bladder cancer |
| 12. | Lumisight | pegulicianine | 4/17/2024 | To use as an optical imaging agent for the detection of cancerous tissue |
| 11. | Zevtera | ceftobiprole medocaril sodium | 4/3/2024 | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia Press Release |
| 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 |
| 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 Press Release |
| 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).