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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2023
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2023

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.

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 that CDER approved in 2023. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2023.
  • 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.

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*
1. Leqembi


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
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 
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
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
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
8. Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia
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
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
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
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
21. Posluma flotufolastat F 18 5/25/2023 To use with positron emission tomography imaging in certain patients with prostate cancer
22. Inpefa sotagliflozin 5/26/2023

​To treat heart failure 

*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 FDA-approved Prescribing Information (click on the Drug Name).

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