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 NameActive IngredientApproval DateFDA-approved use on approval date*
37.NexoBrid

anacaulase-bcdb

12/28/2022To remove eschar in adults with deep partial thickness or full thickness thermal burns
Drug Trials Snapshot
36.Briumvi

ublituximab-xiiy

12/28/2022To treat relapsing forms of multiple sclerosis
Drug Trials Snapshot 
35.Xenoview

hyperpolarized Xe-129

12/23/2022To evaluate pulmonary function and imaging
Drug Trials Snapshot
34.Lunsumio

mosunetuzumab-axgb

12/22/2022To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma
Drug Trials Snapshot
33.Sunlencalenacapavir12/22/2022To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations
Press Release
Drug Trials Snapshot
32.Krazatiadagrasib12/12/2022

To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy
Drug Trials Snapshot

31.Rezlidhiaolutasidenib12/1/2022

To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
Drug Trials Snapshot

30.Tzieldteplizumab-mzwv11/18/22

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

29.Elahere

mirvetuximab soravtansine-gynx

11/14/2022To treat patients with recurrent ovarian cancer that is resistant to platinum therapy
Drug Trials Snapshot
28.Tecvayliteclistamab-cqyv10/25/2022To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy
Drug Trials Snapshot
27.Imjudotremelimumab10/21/2022To treat unresectable hepatocellular carcinoma
Drug Trials Snapshot
26.Lytgobifutibatinib9/30/2022

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

25.Relyvriosodium phenylbutyrate/taurursodiol9/29/2022

To treat amyotrophic lateral sclerosis (ALS)
Press Release
Drug Trials Snapshot

24.Omlontioomidenepag isopropyl ophthalmic solution9/22/2022To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension
Drug Trials Snapshot
23.Eluciremgadopiclenol9/21/2022To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body
Drug Trials Snapshot
22.Terlivazterlipressin9/14/2022To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
Drug Trials Snapshot
21.Rolvedoneflapegrastim9/9/2022To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
Drug Trials Snapshot
20.Sotyktudeucravacitinib9/9/2022To treat moderate-to-severe plaque psoriasis
Drug Trials Snapshot
19.DaxxifydaxibotulinumtoixnA-lanm9/7/2022To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
Drug Trials Snapshot
18.Spevigospesolimab-sbzo9/1/2022To treat generalized pustular psoriasis flares
Drug Trials Snapshot
17.XenpozymeOlipudase alfa8/31/2022To treat Acid Sphingomyelinase Deficiency
Press Release
Drug Trials Snapshot
16.Amvuttravutrisiran6/13/2022

To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
Drug Trials Snapshot

15.Vtamatapinarof5/23/2022To treat plaque psoriasis
Drug Trials Snapshot
14.Mounjarotirzepatide5/13/2022To improve blood sugar control in diabetes, in addition to diet and exercise 
Press Release
Drug Trials Snapshot
13.Voqueznavonoprazan, amoxicillin, and clarithromycin5/3/2022To treat Helicobacter pylori infection
Drug Trials Snapshot
12.Camzyosmavacamten4/28/2022To treat certain classes of obstructive hypertrophic cardiomyopathy
Drug Trials Snapshot
11.Vivjoaoteseconazole4/26/2022To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential
Drug Trials Snapshot
10.Pluvictolutetium (177Lu) vipivotide tetraxetan3/23/2022To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
Drug Trials Snapshot
9.Opdualagnivolumab and relatlimab-rmbw3/18/2022

To treat unresectable or metastatic melanoma
Drug Trials Snapshot

8.Ztalmyganaxolone3/18/2022To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
Drug Trials Snapshot
7.Vonjopacritinib2/28/2022To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets
6.Pyrukyndmitapivat2/17/2022To treat hemolytic anemia in pyruvate kinase deficiency
Drug Trials Snapshot
5.Enjaymosutimlimab-jome2/4/2022To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease
Drug Trials Snapshot
4.Vabysmofaricimab-svoa1/28/2022To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema
Drug Trials Snapshot
3.

Kimmtrak

tebentafusp-tebn1/25/2022To treat unresectable or metastatic uveal melanoma
Drug Trials Snapshot
2.Cibinqoabrocitinib1/14/2022To treat refractory, moderate-to-severe atopic dermatitis
Drug Trials Snapshot
1.Quviviqdaridorexant1/7/2022To treat insomnia
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).