New Drugs

Brand/Generic Company Description
Brenzavvy
bexagliflozin
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TheracosBio

A new sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

Daybue
trofinetide
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Acadia Pharm

A new medication for the treatment of Rett syndrome (unknown mechanism).

Elfabrio
pegunigalsidase alfa-iwxj
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Chiesi USA

A new hydrolytic lysosomal neutral glycosphingolipid-specific enzyme for Fabry disease.

Epkinly
epcoritamab-bysp
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Genmab US

A new bispecific CD20-directed CD3 T-cell engager for diffuse large B-cell lymphoma.

Filspari
sparsentan
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Travere Therapeutics

A new endothelin and angiotensin II receptor antagonist to reduce proteinuria in adults.

Inpefa
sotagliflozin
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Lexicon

A new sodium-glucose cotransporter 2 (SGLT2) inhibitor to reduce cardiovascular death, heart failure-related hospitalization, and urgent heart failure visits.

Jaypirca
pirtobrutinib
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Eli Lilly

A new kinase inhibitor for the treatment of mantle cell lymphoma (MCL).

Jesduvroq
daprodustat
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GlaxoSmithKline

A new oral hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor for the treatment of anemia in patients with chronic kidney disease receiving dialysis.

Joenja
Leniolisib
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Pharming Healthcare

A new kinase inhibitor for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS).

Lamzede
velmanase alfa-tycv
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Chiesi USA

A new recombinant human lysosomal alpha-mannosidase for the treatment of non-central nervous system manifestations of alpha-mannosidiosis.

Leqembi
lecanemab-irmb
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Eisai

A new amyloid beta-directed antibody for the treatment of Alzheimer’s disease.

Miebo
perfluorohexyloctane
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Bausch & Lomb

A new semifluorinated alkane for dry eye disease (unknown mechanism).

Orserdu
elacestrant
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Stemline Therapeutics

A new estrogen receptor antagonist for the treatment of breast cancer.

Paxlovid
nirmatrelvir/ritonavir
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Pfizer

A new antiviral for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (previously available through an emergency use authorization [EUA]).

Qalsody
tofersen
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Biogen

A new antisense oligonucleotide for the treatment of amyotrophic lateral sclerosis (ALS).

Rezzayo
rezafungin
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Melinta Therapeutics

A new echinocandin antifungal for the treatment of candidemia and invasive candidiasis.

Skyclarys
omaveloxolone
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Reata Pharmaceuticals

A new treatment of Friedreich’s ataxia (unknown mechanism).

Veozah
fezolinetant
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Astellas Pharma

A new neurokinin 3 (NK3) receptor antagonist for vasomotor menopausal symptoms.

Xacduro
sulbactam/durlobactam
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Astellas Pharma

A new beta-lactam/beta-lactam inhibitor antibiotic for hospital-acquired or ventilator-associated bacterial pneumonia.

Yuflyma
adalimumab-aaty
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Celltrion USA

A new biosimilar to Humira.

Zavzpret
zavegepant
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Pfizer

A new calcitonin gene-related peptide (CGRP) receptor antagonist for treatment of acute migraine in adults.

Zejula
niraparib
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GlaxoSmithKline

A new poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian, fallopian tube, or peritoneal cancers.

Zynyz
retifanlimab
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Incyte

A new programmed death receptor-1 (PD-1) blocking antibody for the treatment of Merkel cell carcinoma.

Brand/Generic Company Description
Abilify Asimtufii
aripiprazole
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Otsuka America

A new extended-release injectable suspension for schizophrenia and bipolar 1 disorder.

Airsupra
albuterol/budesonide
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AstraZeneca

A new combination metered-dose inhaler for the treatment of asthma.

Atorvaliq
atorvastatin
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CMP Pharma

A new oral suspension to lower cholesterol.

Combogesic
acetaminophen/ ibuprofen
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AFT Pharm

A new combination product for the treatment of mild to moderate acute pain.

Liqrev
sildenafil
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CMP Pharma

A new oral suspension for pulmonary arterial hypertension (PAH).

Lumryz
sodium oxybate
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Avadel CNS Pharmaceuticals

A new extended-release powder for oral suspension for the treatment of narcolepsy.

Mekinist
trametinib
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Novartis

A new oral solution for unresectable or metastatic melanoma.

Motpoly XR
lacosamide
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Aucta Pharmaceuticals

A new extended-release capsule for partial-onset seizures.

Opvee
nalmefene
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Opiant

A new nasal spray for known or suspected opioid overdose.

Prevduo
neostigmine/glycopyrrolate
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Slayback Pharma

A new fixed-dose combination to reverse the effects of non-depolarizing neuromuscular blocking agents after surgery.

Rizafilm
rizatriptan
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IntelGenX

A new oral film for the treatment of acute migraine with or without aura.

Rykindo
risperidone
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Shandong Luye Pharm

A new long-acting injectable for schizophrenia and bipolar disorder.

Syfovre
pegcetacoplan
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Apellis Pharm

A new injection for intravitreal use to treat geographic atrophy secondary to age-related macular degeneration.

Symbicort Aerosphere
budesonide/formoterol
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AstraZeneca

A new pressurized metered-dose inhaler for chronic obstructive pulmonary disease (COPD).

Tafinlar
dabrafenib
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Novartis

A new tablet for oral suspension for unresectable or metastatic melanoma.

Trikafta
elexacaftor/tezacaftor/ivacaftor
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Vertex Pharmaceuticals

A new fixed-dose combination tablet co-packaged with ivacaftor tablets for cystic fibrosis (CF).

Uzedy
risperidone
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Teva Pharmaceuticals

A new extended-release injectable suspension for schizophrenia

Vevye
cyclosporine
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Novaliq

A new 0.1% ophthalmic solution for dry eye disease.

zolpidem
zolpidem
Almatica Pharma

A new immediate-release capsule for short-term treatment of insomnia.

Brand/Generic Company Description
Makena
hydroxyprogesterone caproate
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AMAG Pharmaceuticals

A progestin to reduce the risk of preterm birth.