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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2021
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2021

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 2021. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2021 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*
18. Zynlonta loncastuximab tesirine-lpyl 4/23/2021 To treat certain types of relapsed or refractory large B-cell lymphoma
17. Jemperli dostarlimab-gxly 4/22/2021 To treat endometrial cancer
Press Release
16. Nextstellis drospirenone and estetrol tablets 4/15/2021 To prevent pregnancy
15. Qelbree viloxazine 4/2/2021 For the treatment of attention deficit hyperactivity disorder
14. Zegalogue dasiglucagon 3/22/2021 To treat severe hypoglycemia
13. Ponvory ponesimod 3/18/2021 To treat patients with relapsing forms of multiple sclerosis
12. Fotivda tivozanib 3/10/2021 To treat patients with renal cell carcinoma
11 Azstarys serdexmethylphenidate and
3/2/2021 For the treatment of Attention Deficit Hyperactivity
10. Pepaxto melphalan flufenamide 2/26/2021 For the treatment of certain patients with relapsed or refractory multiple myeloma
9. Nulibry fosdenopterin 2/26/2021 To treat patients with the rare genetic disease molybdenum cofactor deficiency Type A
Press Release
8. Amondys 45 casimersen 2/25/2021 For the treatment of Duchenne muscular dystrophy
Press Release
7. Cosela trilacicilib 2/12/2021 To mitigate chemotherapy-induced myelosuppression in adult patients with small cell lung cancer
Press Release
6. Evkeeza evinacumab-dgnb 2/11/2021 For the treatment of homozygous familial hypercholesterolemia
5. Ukoniq umbralisib 2/5/2021 For the treatment of certain patients with marginal zone lymphoma and follicular lymphoma
4. Tepmetko tepotinib 2/3/2021 To treat non-small cell lung cancer
3. Lupkynis voclosporin 1/22/2021 To treat lupus nephritis
Drug Trials Snapshot
2. Cabenuva cabotegravir and rilpivirine 1/21/2021 To treat HIV
Press Release
Drug Trials Snapshot
1. Verquvo vericiguat 1/19/2021 To treat chronic heart failure
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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