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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2022
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2022

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 2022. 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 2022. 
  • 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*
30. Tzield teplizumab-mzwv 11/18/22

To delay the onset of stage 3 type 1 diabetes
Press Release

29. Elahere

mirvetuximab soravtansine-gynx

11/14/2022

To treat patients with recurrent ovarian cancer that is resistant to platinum therapy

28. Tecvayli teclistamab-cqyv 10/25/2022 To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy
27. Imjudo tremelimumab 10/21/2022 To treat unresectable hepatocellular carcinoma
26. Lytgobi futibatinib 9/30/2022

To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements

25. Relyvrio sodium phenylbutyrate/taurursodiol 9/29/2022

To treat amyotrophic lateral sclerosis (ALS)
Press Release

24. Omlonti oomidenepag isopropyl ophthalmic solution 9/22/2022 To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension
23. Elucirem gadopiclenol 9/21/2022 To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body
22. Terlivaz terlipressin 9/14/2022 To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
21. Rolvedon eflapegrastim 9/9/2022 To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
20. Sotyktu deucravacitinib 9/9/2022 To treat moderate-to-severe plaque psoriasis
19. Daxxify daxibotulinumtoixnA-lanm 9/7/2022 To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
18. Spevigo spesolimab-sbzo 9/1/2022 To treat generalized pustular psoriasis flares
17. Xenpozyme Olipudase alfa 8/31/2022 To treat Acid Sphingomyelinase Deficiency
Press Release
16. Amvuttra vutrisiran 6/13/2022

To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis

15. Vtama tapinarof 5/23/2022 To treat plaque psoriasis
14. Mounjaro tirzepatide 5/13/2022 To improve blood sugar control in diabetes, in addition to diet and exercise 
Press Release
13. Voquezna vonoprazan, amoxicillin, and clarithromycin 5/3/2022 To treat Helicobacter pylori infection
12. Camzyos mavacamten 4/28/2022 To treat certain classes of obstructive hypertrophic cardiomyopathy
11. Vivjoa oteseconazole 4/26/2022 To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential
10. Pluvicto lutetium (177Lu) vipivotide tetraxetan 3/23/2022 To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
9. Opdualag nivolumab and relatlimab-rmbw 3/18/2022 To treat unresectable or metastatic melanoma
8. Ztalmy ganaxolone 3/18/2022 To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
7. Vonjo pacritinib 2/28/2022 To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets
6. Pyrukynd mitapivat 2/17/2022 To treat hemolytic anemia in pyruvate kinase deficiency
5. Enjaymo sutimlimab-jome 2/4/2022 To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease
4. Vabysmo faricimab-svoa 1/28/2022 To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema
3.

Kimmtrak

tebentafusp-tebn 1/25/2022 To treat unresectable or metastatic uveal melanoma 
2. Cibinqo abrocitinib 1/14/2022 To treat refractory, moderate-to-severe atopic dermatitis
1. Quviviq daridorexant 1/7/2022 To treat insomnia

*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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