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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2020
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2020

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With 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, CDER provides scientific and regulatory advice needed to bring new therapies to market.

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.

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

  • Some of these products are innovative new products that never have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2020. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2020 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.

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, 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 have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. 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*
27. Rukobia fostemsavir 7/2/2020 To treat HIV
Press Release
26. Byfavo remimazolam 7/2/2020 For sedation
25. Dojolvi triheptanoin 6/30/2020 To treat molecularly long-chain fatty acid oxidation disorders
24. Zepzelca lurbinectedin 6/15/2020 To treat metastatic small cell lung cancer
Drug Trials Snapshot
23, Uplizna inebilizumab-cdon 6/11/2020 To treat neuromyelitis optica spectrum disorder
Press Release
Drug Trials Snapshot
22. Tauvid flortaucipir F18 5/28/2020 Diagnostic agent for patients with Alzheimer’s disease
Press Release
Drug Trials Snapshot
21. Artesunate artesunate 5/26/2020 To treat severe malaria
Press Release
20. Cerianna fluoroestrdiol F18 5/20/2020 Diagnostic imaging agent for certain patients with breast cancer
Drug Trials Snapshot
19. Qinlock ripretinib 5/15/2020 To treat advanced gastrointestinal-stromal tumors
Press Release
Drug Trials Snapshot
18. Retevmo selpercatinib 5/8/2020 To treat lung and thyroid cancers
Press Release
Drug Trials Snapshot
17. Tabrecta capmatinib 5/6/2020 To treat patients with non small cell lung cancer
Press Release
Drug Trials Snapshot
16. Ongentys opicapone 4/24/2020 To treat patients with Parkinson’s disease experiencing “off” episodes
Drug Trials Snapshot
15. Trodelvy sacituzumab govitecan-hziy 4/22/2020 To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease
Press Release
Drug Trials Snapshot
14. Pemazyre pemigatinib 4/17/2020 To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts
Press Release
Drug Trials Snapshot
13. Tukysa tucatinib 4/17/2020 To treat advanced unresectable or metastatic HER2-positive breast cancer
Drug Trials Snapshot
12. Koselugo selumetinib 4/10/2020 To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves
Drug Trials Snapshot
11. Zeposia ozanimod 3/25/2020 To treat relapsing forms of multiple sclerosis
Drug Trials Snapshot
10. Isturisa osilodrostat 3/6/2020 To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease
Press Release
Drug Trials Snapshot
9. Sarclisa isatuximab 3/2/2020 To treat multiple myloma
Press Release
Drug Trials Snapshot
8. Nurtec ODT rimegepant 2/27/2020 To treat migraine
Drug Trials Snapshot
7. Barhemsys amisulpride 2/26/2020 To help prevent nausea and vomiting after surgery
Drug Trial Snapshot
6. Vyepti eptinezumab-jjmr 2/21/2020 For the preventive treatment of migraine in adults
Drug Trials Snapshot
5. Nexletol

bempedoic acid

2/21/2020 To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
Drug Trials Snapshot
4. Pizensy

lactitol

2/12/2020 To treat chronic idiopathic constipation (CIC) in adults
Drug Trials Snapshot
3. Tazverik tazemetostat 1/23/2020 To treat epithelioid sarcoma
Press Release
Drug Trials Snapshot
2. Tepezza teprotumumab-trbw 1/21/2020 To treat Thyroid eye disease
Press Release
Drug Trials Snapshot
1. Ayvakit avapritinib 1/9/2020 To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)
FDA Information
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 FDA-approved Prescribing Information (click on the Drug Name).

 

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