No.
Drug Name
Active Ingredient
Approval Date
FDA-approved use on approval date*
1
Quviviq
daridorexant
1/7/22
To treat insomnia
2
Cibinqo
abrocitinib
1/14/22
To treat refractory, moderate-to-severe atopic dermatitis
3
Kimmtrak
tebentafusp-tebn
1/25/22
To treat unresectable or metastatic uveal melanoma
4
Vabysmo
faricimab-svoa
1/28/22
To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema
5
Enjaymo
sutimlimab-jome
2/4/22
To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease
6
Pyrukynd
mitapivat
2/17/22
To treat hemolytic anemia in pyruvate kinase deficiency
7
Vonjo
pacritinib
2/28/22
To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets
8
Ztalmy
ganaxolone
3/18/22
To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
9
Opdualag
nivolumab and relatlimab-rmbw
3/18/22
To treat unresectable or metastatic melanoma
10
Pluvicto
lutetium (177Lu) vipivotide tetraxetan
3/23/22
To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
11
Vivjoa
oteseconazole
4/26/22
To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential
12
Voquezna
vonoprazan, amoxicillin, and clarithromycin
5/3/22
To treat Helicobacter pylori infection
13
Camzyos
mavacamten
4/28/22
To treat certain classes of obstructive hypertrophic cardiomyopathy
14
Vtama
tapinarof
5/23/22
To treat plaque psoriasis
15
Mounjaro
tirzepatide
5/13/22
To improve blood sugar control in diabetes, in addition to diet and exercise Press Release
16
Amvuttra
vutrisiran
6/13/22
To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
17
Xenpozyme
Olipudase alfa
8/31/22
To treat Acid Sphingomyelinase Deficiency
18
Spevigo
spesolimab-sbzo
9/1/22
To treat generalized pustular psoriasis flares
19
Daxxify
daxibotulinumtoixnA-lanm
9/7/22
To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
20
Sotyktu
deucravacitinib
9/9/22
To treat moderate-to-severe plaque psoriasis
21
Rolvedon
9/9/22
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
22
Terlivaz
eflapegrastim
9/14/22
To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
23
Elucirem
gadopiclenol
9/21/22
To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body
24
Omlonti
oomidenepag isopropyl ophthalmic solution
9/22/22
To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension
25
Relyvrio
sodium phenylbutyrate/taurursodiol
9/29/22
To treat amyotrophic lateral sclerosis (ALS) Press Release
26
Lytgobi
futibatinib
9/30/22
To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
27
Imjudo
tremelimumab
10/21/22
To treat unresectable hepatocellular carcinoma
28
Tecvayli
teclistamab-cqyv
10/25/22
To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy
29
Elahere
mirvetuximab soravtansine-gynx
11/14/22
To treat patients with recurrent ovarian cancer that is resistant to platinum therapy
30
Tzield
teplizumab-mzwv
11/18/22
To delay the onset of stage 3 type 1 diabetes Press Release
31
Rezlidhia
olutasidenib
12/1/22
To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
32
Krazati
adagrasib
12/12/22
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
33
Sunlenca
lenacapavir
12/22/22
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
34
Lunsumio
mosunetuzumab-axgb
12/22/22
To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma
35
Xenoview
hyperpolarized Xe-129
12/22/22
To evaluate pulmonary function and imaging
