The document lists 17 new molecular entities approved by the FDA in 2022, including drugs to treat insomnia, eczema, hemolytic anemia, myelofibrosis, seizures, prostate cancer, vulvovaginal candidiasis, hypertrophic cardiomyopathy, Helicobacter pylori infection, type 2 diabetes mellitus, plaque psoriasis, polyneuropathy of hereditary transthyretin-mediated amyloidosis, hepatorenal syndrome, elevated intraocular pressure, amyotrophic lateral sclerosis, bile duct cancer, acute myeloid leukemia, non-small cell lung cancer, HIV-1 infection, and as a hyperpolarized contrast agent. Each drug is listed with its active ingredient

1. New Molecular Entity approved by FDA 2022
Drug Name Active ingredient Strength Dosage form/Route Indication
Quviviq
Daridorexant
hydrochloride
Eq 25mg base Tablet; Oral
https://www.accessdata.fda.gov/scripts/cd
er/daf/index.cfm?event=overview.process
&ApplNo=214985
TTT of
insomnia
Eq 50mg base
Cibinqo Abrocitinib
50mg
Tablet; Oral
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proces
s&ApplNo=213871
TTT of
Eczema
100mg
200mg
Pyrukynd Mitapivat sulfate
Eq 5mg base
Tablet; Oral
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proces
s&ApplNo=216196
TTT of
Hemolytic
anemia
Eq 20mg base
Eq 50mg base
Vonjo Pacritinib citrate Eq 100mg base
Capsule; Oral
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proces
s&ApplNo=208712
TTT of
myelofibrosis
Ztalmy Ganaxolone 50mg/ml
Suspension; Oral
https://www.accessdata.fda.gov/scripts/cd
er/daf/index.cfm?event=overview.process
&ApplNo=215904
TTT of
seizures
Pluvicto
Lutetium lu-177
vipivotide tetraxetan
27mci/ML
Solution; Intravenous
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proces
s&ApplNo=215833
TTT of
prostate
cancer

2. Drug Name
Active
ingredient
Strength Dosage form/Route Indication
Vivjoa Oteseconazole 150mg Capsule; Oral
https://www.accessdata.fda.gov/scripts/cder/daf/index
.cfm?event=overview.process&ApplNo=215888
Treat Recurrent
vulvovaginal
candidiasis
Camzyos Mavacamten
2.5mg
Capsule; Oral
https://www.accessdata.fda.gov/scripts/cder/daf/index
.cfm?event=overview.process&ApplNo=214998
Treat Obstructive
hypertrophic
cardiomyopathy
5mg
10mg
15mg
Voquezna
Triple Pak
Amoxicillin;
clarithromycin;
vonoprazan
fumarate
500mg;
500mg;
eq 20mg base
Capsule, tablet, tablet; oral
https://www.accessdata.fda.gov/scripts/cder/daf/index
.cfm?event=overview.process&ApplNo=215152
TTT of
Helicobacter
pylori
Unjaro Tirzepatide
2.5mg/0.5ml
(2.5mg/0.5ml)
Solution; subcutaneous
https://www.accessdata.fda.gov/scripts/cder/daf/index
.cfm?event=overview.process&ApplNo=215866
TTT of Type 2
diabetes mellitus
5mg/0.5ml (5mg/0.5ml)
7.5mg/0.5ml
(7.5mg/0.5ml)
10mg/0.5ml (10mg/0.5ml)
12.5mg/0.5ml
(12.5mg/0.5ml)
15mg/0.5ml (15mg/0.5ml)
New Molecular Entity approved by FDA 2022

3. Drug Name
Active
ingredient
Strength Dosage form/Route Indication
Vtama Tapinarof 1% Cream;topical
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proce
ss&ApplNo=215272
TTT of Plaque psoriasis
Amvuttra Vutrisiran 25mg/0.5ml
(25mg/0.5ml)
Solution; subcutaneous
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proce
ss&ApplNo=215515
Treat polyneuropathy of
hereditary transthyretin-
mediated amyloidosis
Sotyktu Deucravacitinib 6mg Tablet;oral
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proce
ss&ApplNo=214958
TTT of Plaque psoriasis
Terlivaz Terlipressin
acetate
Eq 0.85mg
base/vial
Powder;intravenous
https://www.accessdata.fda.gov/scripts/c
der/daf/index.cfm?event=overview.proce
ss&ApplNo=022231
TTT of hepatorenal
syndrome
New Molecular Entity approved by FDA 2022

4. Drug
Name
Active
ingredient
Strength
Dosage
form/Route
Indication
Elucirem Gadopiclenol 1.4553gm/3ml (485.1mg/ml) Solution;intravenous
https://www.accessdata.fda.gov/scripts
/cder/daf/index.cfm?event=overview.p
rocess&ApplNo=216986
Gadolinium-based
contrast agent
(GBCA)
3.63825gm/7.5ml (485.1mg/ml)
4.851gm/10ml (485.1mg/ml)
7.2765gm/15ml (485.1mg/ml)
14.553gm/30ml (485.1mg/ml)
24.255gm/50ml (485.1mg/ml)
48.51gm/100ml (485.1mg/ml)
Omlonti
Omidenepag
isopropyl
0.002%
Solution;ophthalmic
https://www.accessdata.fda.gov/scripts
/cder/daf/index.cfm?event=overview.p
rocess&ApplNo=215092
Reduction of
elevated intraocular
pressure (IOP)
Relyvrio
Sodium
phenylbutyrate;
taurursodiol
3gm/packet; 1gm/packet
For suspension;oral
https://www.accessdata.fda.gov/scripts
/cder/daf/index.cfm?event=overview.p
rocess&ApplNo=216660
Amyotrophic lateral
sclerosis (ALS)
New Molecular Entity approved by FDA 2022

5. Drug Name Active ingredient Strength Dosage form/Route Indication
Lytgobi Futibatinib 4mg
Tablet;oral
https://www.accessdata.fda.gov/scripts/cder
/daf/index.cfm?event=overview.process&A
pplNo=214801
Bile duct cancer
(intrahepatic
cholangiocarcinoma)
Rezlidhia Olutasidenib 150mg
Capsule;oral
https://www.accessdata.fda.gov/scripts/cder
/daf/index.cfm?event=overview.process&A
pplNo=215814
Acute myeloid
leukemia (AML)
Krazati Adagrasib 200mg
Tablet;oral
https://www.accessdata.fda.gov/scripts/cder
/daf/index.cfm?event=overview.process&A
pplNo=216340
Non-small cell lung
cancer (NSCLC)
Sunlenca Lenacapavir 300mg
Injectable;injection
https://www.accessdata.fda.gov/scripts/cder
/daf/index.cfm?event=overview.process&A
pplNo=215973
Treat HIV-1 infection
Sunlenca Lenacapavir 300mg
Tablet;oral
https://www.accessdata.fda.gov/scripts/cder
/daf/index.cfm?event=overview.process&A
pplNo=215974
Treat HIV-1 infection
Xenoview
Xenon xe 129
hyperpolarized
1000ml
Inhalant;oral
https://www.accessdata.fda.gov/scripts/cder
/daf/index.cfm?event=overview.process&A
pplNo=214375
Hyperpolarized
contrast agent
New Molecular Entity approved by FDA 2022