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  1. Novel Drug Approvals at FDA

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 NameActive IngredientApproval DateFDA-approved use on approval date*
48.Tryngolzaolezarsen12/19/2024To treat familial chylomicronemia syndrome
47.Ensacoveensartinib12/18/2024To treat non-small cell lung cancer
46.Crenessitycrinecerfont12/13/2024To treat classic congenital adrenal hyperplasia 
Press Release
45.Unloxcytcosibelimab-ipdl12/13/2024To treat cutaneous squamous cell carcinoma
44.Bizengrizenocutuzumab-zbco12/4/2024To treat non-small cell lung cancer and pancreatic adenocarcinoma 
43.Iomervuiomeprol11/27/2024For use as a radiographic contrast agent
42.Rapiblyklandiolol11/22/2024To treat supraventricular tachycardia
41.Attrubyacoramidis11/22/2024To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis
40.Ziiherazanidatamab-hrii11/20/2024To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer
39.Revuforjrevumenib11/15/2024To treat relapsed or refractory acute leukemia
38.Orlynvahsulopenem etzadroxil, probenecid10/25/2024To treat uncomplicated urinary tract infections (uUTI)
37.Vyloyzolbetuximab-clzb10/18/2024To treat gastric or gastroesophageal junction adenocarcinoma
Drug Trials Snapshots: VYLOY
36.Hympavzimarstacimab-hncq10/11/2024To prevent or reduce bleeding episodes related to hemophilia A or B
Press Release
35.Itovebiinavolisib10/10/2024To treat locally advanced or metastatic breast cancer
34.Flyrcadoflurpiridaz F 189/27/2024A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction
33.Cobenfyxanomeline and trospium chloride9/26/2024To treat schizophrenia
Press Release
32.Aqneursa levacetylleucine9/24/2024To treat Niemann-Pick disease type C
Press Release
Drug Trials Snapshot
31.Miplyffaarimoclomol9/20/2024To treat Niemann-Pick disease type C
Press Release
Drug Trials Snapshot
30.Ebglysslebrikizumab-lbkz9/13/2024To treat moderate-to-severe atopic dermatitis
Drug Trials Snapshot
29.Lazcluzelazertinib8/19/2024To treat non-small cell lung cancer
28.Niktimvoaxatilimab-csfr8/14/2024To treat chronic graft-versus-host disease (cGVHD)
Drug Trials Snapshot
27.Livdelziseladelpar8/14/2024To treat primary biliary cholangitis (PBC)
Drug Trials Snapshot
26.Nemluvionemolizumab-ilto8/12/2024To treat prurigo nodularis
Drug Trials Snapshot
25.Yorvipathpalopegteriparatide8/9/2024To treat hypoparathyroidism
Drug Trials Snapshot
24.Voranigovorasidenib8/6/2024To treat Grade 2 astrocytoma or oligodendroglioma
Drug Trials Snapshot
23.Leqselvideuruxolitinib7/25/2024To treat severe alopecia areata
Drug Trials Snapshot
22.Kisunladonanemab-azbt7/2/2024To treat Alzheimer’s disease
Drug Trials Snapshot
21.Ohtuvayreensifentrine6/26/2024To treat chronic obstructive pulmonary disease
Drug Trials Snapshot
20.Piaskycrovalimab-akkz6/20/2024To treat paroxysmal nocturnal hemoglobinuria
Drug Trials Snapshot
19.Sofdrasofpironium6/18/2024To treat primary axillary hyperhidrosis
Drug Trials Snapshot
18.Iqirvoelafibranor6/10/2024To treat primary biliary cholangitis in combination with ursodeoxycholic acid
Drug Trials Snapshot
17.Ryteloimetelstat6/6/2024To treat low- to intermediate-1 risk myelodysplastic syndromes
Drug Trials Snapshot
16.Imdelltratarlatamab-dlle5/16/2024To treat extensive stage small cell lung cancer
Drug Trials Snapshot
15.Xolremdimavorixafor4/26/2024To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)
Drug Trials Snapshot
14.Ojemdatovorafenib4/23/2024To treat relapsed or refractory pediatric low-grade glioma
Drug Trials Snapshot
13.Anktivanogapendekin alfa inbakicept-pmln4/22/2024To treat bladder cancer
Drug Trials Snapshot
12.Lumisightpegulicianine4/17/2024To use as an optical imaging agent for the detection of cancerous tissue
Drug Trials Snapshot
11.Zevteraceftobiprole medocaril sodium4/3/2024To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia
Press Release
Drug Trials Snapshot
10.Voydeyadanicopan3/29/2024To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria
Drug Trials Snapshot
9.Vafseovadadustat3/27/2024To treat anemia due to chronic kidney disease
Drug Trials Snapshot
8.Winrevairsotatercept-csrk3/26/2024To treat pulmonary arterial hypertension
Drug Trials Snapshot
7.Duvyzatgivinostat3/21/2024To treat Duchenne muscular dystrophy in individuals aged 6 years and older
Press Release
Drug Trials Snapshot
6.Tryvioaprocitentan3/19/2024To treat hypertension
Drug Trials Snapshot
5.Rezdiffraresmetirom3/14/2024To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring
Press Release
Drug Trials Snapshot
4.Tevimbratislelizumab-jsgr3/13/2024To treat unresectable or metastatic esophageal squamous cell carcinoma
Drug Trials Snapshot
3.LetyboletibotulinumtoxinA-wlbg2/29/2024To temporarily improve the appearance of moderate-to-severe glabellar lines
Drug Trials Snapshot
2.Exblifepcefepime, enmetazobactam2/22/2024To treat complicated urinary tract infections
Drug Trials Snapshot
1.Zelsuvmiberdazimer1/5/2024To 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).

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