Novel Drug Approvals for 2022
What are "Novel" Drugs?
"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
FDA Novel Drug Therapy Approvals for 2022
In 2022, CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biological products under Biologics License Applications (BLAs). The active ingredient(s) in a novel drug has never been approved in the U.S.
CDER’s novel drug approvals for 2022 are listed below. For more information, download the report Advancing Health Through Innovation: New Drug Therapy Approvals for 2022.
| 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 (FDA Archive) 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 Drug Trials Snapshot |
| 31. | Rezlidhia | olutasidenib | 12/1/2022 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation Drug Trials Snapshot |
| 30. | Tzield | teplizumab-mzwv | 11/18/22 | To delay the onset of stage 3 type 1 diabetes Press Release (FDA Archive) Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 25. | Relyvrio | sodium phenylbutyrate/taurursodiol | 9/29/2022 | To treat amyotrophic lateral sclerosis (ALS) Press Release (FDA Archive) Drug Trials Snapshot |
| 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 (FDA Archive) Drug Trials Snapshot |
| 16. | Amvuttra | vutrisiran | 6/13/2022 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis Drug Trials Snapshot |
| 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 (FDA Archive) 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 Drug Trials Snapshot |
| 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. | Kimmtrak | 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).