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  1. Novel Drug Approvals at FDA

Novel Drug Approvals for 2024

Helping Guide the Way for New Medicines

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.

A Wide Range of Products

Each year, CDER approves a wide range of new drugs and biological products:

  • Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER and organized by calendar year. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved by the Center for Biologics Evaluation and Research.
  • Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.

New Molecular Entities (NMEs)

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date*
15. Xolremdi mavorixafor 4/26/2024 To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)
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
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
7. Duvyzat givinostat 3/21/2024 To treat Duchenne muscular dystrophy in individuals aged 6 years and older
Press Release
6. Tryvio aprocitentan 3/19/2024 To treat hypertension
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
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
1. Zelsuvmi berdazimer 1/5/2024 To treat molluscum contagiosum

*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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