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Home Updates

Novel Drug Approvals for 2022

List of Novel Drug Approvals for 2022

Nabin Bista by Nabin Bista
January 3, 2023
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Novel Drug Approvals for 2022
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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 NameActive IngredientApproval DateFDA-approved use on approval date*
37.NexoBridanacaulase-bcdb12/28/2022To remove eschar in adults with deep partial thickness or full thickness thermal burns
36.Briumviublituximab-xiiy12/28/2022To treat relapsing forms of multiple sclerosis
35.Xenoviewhyperpolarized Xe-12912/23/2022To evaluate pulmonary function and imaging
34.Lunsumiomosunetuzumab-axgb12/22/2022To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma
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
32.Krazatiadagrasib12/12/2022To 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.Rezlidhiaolutasidenib12/1/2022To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
30.Tzieldteplizumab-mzwv11/18/22To delay the onset of stage 3 type 1 diabetes Press Release
29.Elaheremirvetuximab soravtansine-gynx11/14/2022To treat patients with recurrent ovarian cancer that is resistant to platinum therapy
28.Tecvayliteclistamab-cqyv10/25/2022To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy
27.Imjudotremelimumab10/21/2022To treat unresectable hepatocellular carcinoma
26.Lytgobifutibatinib9/30/2022To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
25.Relyvriosodium phenylbutyrate/taurursodiol9/29/2022To treat amyotrophic lateral sclerosis (ALS) Press Release
24.Omlontioomidenepag isopropyl ophthalmic solution9/22/2022To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension
23.Eluciremgadopiclenol9/21/2022To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body
22.Terlivazterlipressin9/14/2022To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
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
20.Sotyktudeucravacitinib9/9/2022To treat moderate-to-severe plaque psoriasis
19.DaxxifydaxibotulinumtoixnA-lanm9/7/2022To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
18.Spevigospesolimab-sbzo9/1/2022To treat generalized pustular psoriasis flares
17.XenpozymeOlipudase alfa8/31/2022To treat Acid Sphingomyelinase Deficiency Press Release
16.Amvuttravutrisiran6/13/2022To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
15.Vtamatapinarof5/23/2022To treat plaque psoriasis
14.Mounjarotirzepatide5/13/2022To improve blood sugar control in diabetes, in addition to diet and exercise  Press Release
13.Voqueznavonoprazan, amoxicillin, and clarithromycin5/3/2022To treat Helicobacter pylori infection
12.Camzyosmavacamten4/28/2022To treat certain classes of obstructive hypertrophic cardiomyopathy
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
10.Pluvictolutetium (177Lu) vipivotide tetraxetan3/23/2022To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
9.Opdualagnivolumab and relatlimab-rmbw3/18/2022To treat unresectable or metastatic melanoma
8.Ztalmyganaxolone3/18/2022To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
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
5.Enjaymosutimlimab-jome2/4/2022To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease
4.Vabysmofaricimab-svoa1/28/2022To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema
3.Kimmtraktebentafusp-tebn1/25/2022To treat unresectable or metastatic uveal melanoma
2.Cibinqoabrocitinib1/14/2022To treat refractory, moderate-to-severe atopic dermatitis
1.Quviviqdaridorexant1/7/2022To treat insomnia

Source: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022



 

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Nabin Bista

Nabin Bista

Hello, Thank You for visiting my blog I am Nabin Bista, Dedicated and self motivated young Pharmacist from Nepal. Blogging is my passion. I am studying B Pharmacy at Institute of Medicine - IOM. If you want me to write about any posts that you found confusing/difficult, please mention in the comments below.

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