FDA Novel Drug Approvals in 2022

FDA Novel Drug Approvals

Published December 31st, 2022

Detected March 13th, 2026

Summary

The FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs in 2022, including new molecular entities (NMEs) and new therapeutic biological products (BLAs). This notice summarizes these approvals and provides a link to the full report.

View original document View source feed page

What changed

The FDA has published a notice detailing the 37 novel drugs approved by its Center for Drug Evaluation and Research (CDER) in 2022. These approvals include both new molecular entities (NMEs) submitted under New Drug Applications (NDAs) and new therapeutic biological products submitted under Biologics License Applications (BLAs). The notice provides a list of these drugs, their active ingredients, approval dates, and FDA-approved uses, along with links to detailed reports and drug information.

This document serves as an informational summary of the FDA's drug approval activities for the year 2022. While it does not impose new regulatory requirements or deadlines, it is a key resource for pharmaceutical and drug manufacturers to understand the landscape of newly approved therapies. Compliance officers should note the types of novel drugs approved, as this can inform research and development strategies and market analysis.

Source document (simplified)

Advancing Health Through Innovation: New Drug Therapy Approvals 2022 (PDF - 7 MB)
Text version

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).