Novel Drug Approvals for 2022

New treatment choices for patients and improvements in to healthcare are frequently the results of innovative pharmaceuticals. The FDA’s Center for Drug Evaluation and Research (CDER) explains to drug developers the necessary study design components and other data needed in the drug application to support a thorough and in-depth assessment when it comes to the development of novel medications and therapeutic biological products. To do this, CDER draws on its knowledge of testing and manufacturing processes, as well as the diseases and ailments that new products are intended to cure.

List of products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER(Center for Drug Evaluation and Research) approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022. Total approved medicine is 37 in 2022.

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