No.
Drug Name
Active Ingredient
Approval Date
FDA-approved use on approval date*
1
Leqembi
lecanemab-irmb
1/6/2023
To treat Alzheimer’s disease
2
Brenzavvy
bexagliflozin
1/20/2023
To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
3
Jaypirca
pirtobrutinib
1/27/2023
To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor
4
Orserdu
elacestrant
1/27/2023
To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
5
Jesduvroq
daprodustat
2/1/2023
To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
6
Lamzede
velmanase alfa-tycv
2/16/2023
To treat non-central nervous system manifestations of alpha-mannosidosis
7
Filspari
sparsentan
2/17/2023
To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
8
Skyclarys
omaveloxolone
2/28/2023
To treat Friedrich’s ataxia
9
Zavzpret
zavegepant
3/9/2023
To treat migraine
10
Daybue
trofinetide
3/10/2023
To treat Rett syndrome
11
Zynyz
retifanlimab-dlwr
3/22/2023
To treat metastatic or recurrent locally advanced Merkel cell carcinoma
12
Rezzayo
rezafungin
3/22/2023
To treat candidemia and invasive candidiasis
13
Joenja
leniolisib
3/24/2023
To treat activated phosphoinositide 3-kinase delta syndrome
14
Qalsody
tofersen
4/25/2023
To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation
15
Elfabrio
pegunigalsidase alfa-iwxj
5/9/2023
To treat confirmed Fabry disease
16
Veozah
fezolinetant
5/12/2023
To treat moderate to severe hot flashes caused by menopause
17
Miebo
perfluorhexyloctane
5/18/2023
To treat signs and symptoms of dry eye disease
18
Epkinly
epcoritamab-bysp
5/19/2023
To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy
19
Xacduro
sulbactam, durlobactam
5/23/2023
To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
20
Paxlovid
nirmatrelvir, ritonavir
5/25/2023
To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19
21
Posluma
flotufolastat F 18
5/25/2023
To use with positron emission tomography imaging in certain patients with prostate cancer
22
Inpefa
sotagliflozin
5/26/2023
To treat heart failure
23
Columvi
glofitamab-gxbm
6/15/2023
To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy
24
Litfulo
ritlecitinib
6/24/2023
To treat severely patchy hair loss
