Novel Drug Approvals for 2022
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 Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 37. | NexoBrid |
anacaulase-bcdb |
12/28/2022 | To remove eschar in adults with deep partial thickness or full thickness thermal burns Drug Trials Snapshot |
| 36. | Briumvi |
ublituximab-xiiy |
12/28/2022 | To treat relapsing forms of multiple sclerosis Drug Trials Snapshot |
| 35. | Xenoview |
hyperpolarized Xe-129 |
12/23/2022 | To evaluate pulmonary function and imaging Drug Trials Snapshot |
| 34. | Lunsumio |
mosunetuzumab-axgb |
12/22/2022 | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma Drug Trials Snapshot |
| 33. | Sunlenca | lenacapavir | 12/22/2022 | To 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. | Krazati | adagrasib | 12/12/2022 |
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 |
| 31. | Rezlidhia | olutasidenib | 12/1/2022 |
To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation |
| 30. | Tzield | teplizumab-mzwv | 11/18/22 |
To delay the onset of stage 3 type 1 diabetes |
| 29. | Elahere |
mirvetuximab soravtansine-gynx |
11/14/2022 | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 27. | Imjudo | tremelimumab | 10/21/2022 | To treat unresectable hepatocellular carcinoma Drug Trials Snapshot |
| 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) |
| 24. | Omlonti | oomidenepag isopropyl ophthalmic solution | 9/22/2022 | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 22. | Terlivaz | terlipressin | 9/14/2022 | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 20. | Sotyktu | deucravacitinib | 9/9/2022 | To treat moderate-to-severe plaque psoriasis Drug Trials Snapshot |
| 19. | Daxxify | daxibotulinumtoixnA-lanm | 9/7/2022 | To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity Drug Trials Snapshot |
| 18. | Spevigo | spesolimab-sbzo | 9/1/2022 | To treat generalized pustular psoriasis flares Drug Trials Snapshot |
| 17. | Xenpozyme | Olipudase alfa | 8/31/2022 | To treat Acid Sphingomyelinase Deficiency Press Release Drug Trials Snapshot |
| 16. | Amvuttra | vutrisiran | 6/13/2022 |
To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 15. | Vtama | tapinarof | 5/23/2022 | To treat plaque psoriasis Drug Trials Snapshot |
| 14. | Mounjaro | tirzepatide | 5/13/2022 | To improve blood sugar control in diabetes, in addition to diet and exercise Press Release Drug Trials Snapshot |
| 13. | Voquezna | vonoprazan, amoxicillin, and clarithromycin | 5/3/2022 | To treat Helicobacter pylori infection Drug Trials Snapshot |
| 12. | Camzyos | mavacamten | 4/28/2022 | To treat certain classes of obstructive hypertrophic cardiomyopathy Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 10. | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | 3/23/2022 | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 5. | Enjaymo | sutimlimab-jome | 2/4/2022 | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease Drug Trials Snapshot |
| 4. | Vabysmo | faricimab-svoa | 1/28/2022 | To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema Drug Trials Snapshot |
| 3. | tebentafusp-tebn | 1/25/2022 | To treat unresectable or metastatic uveal melanoma Drug Trials Snapshot |
|
| 2. | Cibinqo | abrocitinib | 1/14/2022 | To treat refractory, moderate-to-severe atopic dermatitis Drug Trials Snapshot |
| 1. | Quviviq | daridorexant | 1/7/2022 | To 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).