New Drugs

Brand/Generic Company Description
Artesunate
artesunate
Amivas

An injectable antimalarial for treatment of severe malaria.

Ayvakit
avapritinib
Click here for more information
Blueprint Medicines

A kinase inhibitor for advanced gastrointestinal stromal tumor (GIST).

Bafiertam
monomethyl fumarate
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Banner Life Sciences

The active metabolite of dimethyl fumarate for multiple sclerosis.

Barhemsys
amisulpride
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Acacia Pharma

A dopamine-2 antagonist for prevention and treatment of postop nausea and vomiting.

Blenrep
belantamab mafodotin-blmf
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GSK

A monoclonal antibody for multiple myeloma.

Byfavo
remimazolam
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Acacia Pharma

An injectable benzodiazepine for induction and maintenance of procedural sedation.

Cerianna
fluoroestradiol F 18
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Zionexa

A radioactive diagnostic agent for PET imaging to detect estrogen receptor-positive lesions in patients with breast cancer.

Darzalex Faspro
daratumumab/ hyaluronidase-fihj
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Janssen Biotech

Combination monoclonal antibody and hyaluronidase for multiple myeloma.

Dojolvi
triheptanoin
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Ultragenyx Pharm.

A medium-chain triglyceride oral liquid for patients with long-chain fatty acid oxidation disorders.

Enspryng
satralizumab-mwge
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Genentech

An interleukin-6 receptor antagonist for neuromyelitis optica spectrum disorder.

Evrysdi
risdiplam
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Genentech

A survival of motor neuron 2 splicing modifier for spinal muscular atrophy.

Gavreto
pralsetinib
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Blueprint Medicines

A kinase inhibitor for non-small cell lung cancer.

Hulio
adalimumab-fkjp
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Mylan

A biosimilar to Humira.

Inmazeb
atoltivimab/maftivimab/odesivimab-ebgn
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Regeneron

Monoclonal antibodies for treatment of Zaire ebolavirus infection.

Inqovi
decitabine/cedazuridine
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Taiho Oncology

A combination drug for myelodysplastic syndromes.

Isturisa
osilodrostat
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Recordati Rare Diseases

A cortisol synthesis inhibitor for Cushing’s disease.

Kesimpta
ofatumumab
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Novartis

A monoclonal antibody for relapsing forms of multiple sclerosis.

Koselugo
selumetinib
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AstraZeneca

A kinase inhibitor for pediatric neurofibromatosis type 1.

Lampit
nifurtimox
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Bayer HealthCare

An oral antiprotozoal for Chagas disease.

Lyumjev
insulin lispro-aabc
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Lilly

New rapid-acting insulin analog for diabetes.

Monjuvi
tafasitamab-cxix
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Morphosys US

A monoclonal antibody for diffuse large B-cell lymphoma.

Nexletol
bempedoic acid
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Esperion

An adenosine triphosphate-citrate lyase inhibitor for hypercholesterolemia.

Nexlizet
bempedoic acid/ezetimibe
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Esperion

An adenosine triphosphate-citrate lyase inhibitor and cholesterol absorption inhibitor for hypercholesterolemia.

Nurtec ODT
rimegepant
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Biohaven Pharm.

A calcitonin gene-related peptide receptor antagonist for acute treatment of migraine.

Nyvepria
pegfilgrastim-apgf
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Pfizer

A biosimilar to Neulasta.

Olinvyk
oliceridine
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Trevena

Injectable opioid agonist for acute pain.

Ongentys
opicapone
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Neurocrine Biosciences

A COMT inhibitor for Parkinson’s disease patients experiencing “off” episodes.

Palforzia
peanut (Arachis hypogaea) allergen powder-dnfp
Aimmune Therapeutics

An oral immunotherapy for patients with peanut allergy.

Pemazyre
pemigatinib
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Incyte Corp.

A kinase inhibitor for advanced cholangiocarcinoma.

Phesgo
pertuzumab/trastuzumab/hyaluronidase-zzxf
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Genentech

Monoclonal antibodies for HER2-positive breast cancer.

Pizensy
lactitol
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Braintree Labs

An osmotic laxative for chronic idiopathic constipation.

Qinlock
ripretinib
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Deciphera Pharm.

A kinase inhibitor for advanced gastrointestinal stromal tumor (GIST).

QWO
collagenase clostridium histolyticum-aaes
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Endo Pharm.

Combination bacterial collagenases for moderate to severe cellulite in the buttocks of women.

Retevmo
selpercatinib
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Lilly

A kinase inhibitor for metastatic non-small cell lung cancer and medullary thyroid cancer.

Rukobia
fostemsavir
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ViiV Healthcare

A new antiretroviral for multidrug-resistant HIV-1 infection.

Sarclisa
isatuximab-irfc
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Sanofi-Aventis U.S.

A monoclonal antibody for multiple myeloma.

Semglee
insulin glargine
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Mylan

A new long-acting insulin for diabetes.

Sevenfact
factor VIIa (recombinant)-jncw
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HEMA Biologics

A coagulation factor to control bleeding episodes in patients with hemophilia A or B with inhibitors (neutralizing antibodies).

Sogroya
somapacitan-beco
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Novo Nordisk

A human growth hormone analog for adults with growth hormone deficiency.

Tabrecta
capmatinib
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Novartis Pharm.

A kinase inhibitor for metastatic non-small cell lung cancer.

Tauvid
flortaucipir F 18
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Lilly

A radioactive diagnostic agent for PET imaging of the brain for patients being evaluated for Alzheimer’s disease.

Tazverik
tazemetostat
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Epizyme

A methyltransferase inhibitor for advanced epithelioid sarcoma and follicular lymphoma.

Tepezza
teprotumumab-trbw
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Horizon

A monoclonal antibody for thyroid eye disease.

Trodelvy
sacituzumab govitecan-hziy
Click here for more information
Immunomedics

A monoclonal antibody for metastatic breast cancer.

Tukysa
tucatinib
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Seattle Genetics

A kinase inhibitor for advanced breast cancer.

Uplizna
inebilizumab-cdon
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Viela Bio

A monoclonal antibody for neuromyelitis optica spectrum disorder.

Veklury
remdesivir
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Gilead Sciences

A SARS-CoV-2 nucleotide analog RNA polymerase inhibitor for COVID-19 requiring hospitalization.

Viltepso
viltolarsen
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NS Pharma

An antisense oligonucleotide for Duchenne muscular dystrophy.

Vyepti
eptinezumab-jjmr
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Lundbeck

A calcitonin gene-related peptide antagonist for prevention of migraine.

Winlevi
clascoterone
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Cassiopea

An androgen receptor inhibitor topical cream for acne.

Xeglyze
abametapir
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Dr. Reddy’s Labs

A topical pediculicide for head lice.

Zeposia
ozanimod
Click here for more information
Celgene

An oral sphingosine 1-phosphate receptor modulator for relapsing forms of multiple sclerosis.

Zepzelca
lurbinectedin
Click here for more information
Jazz Pharm.

An alkylating drug for metastatic small cell lung cancer.

Brand/Generic Company Description
Alkindi Sprinkle
hydrocortisone
Click here for more information
Eton Pharm.

New oral granule sprinkle formulation for pediatric patients with adrenocortical insufficiency.

Anjeso
meloxicam
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Baudax Bio

An injectable NSAID for moderate to severe pain.

Breztri Aerosphere
budesonide/glycopyrrolate/formoterol fumarate
Click here for more information
AstraZeneca

Combination inhaled corticosteroid, anticholinergic, and LABA for maintenance treatment of COPD.

Bronchitol
mannitol
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Chiesi USA

An oral inhalation powder to improve pulmonary function in adults with cystic fibrosis.

Bynfezia Pen
octreotide
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Sun Pharm.

New subcutaneous pen formulation for patients with acromegaly, carcinoid tumors, or vasoactive intestinal peptide tumors.

Durysta
bimatoprost implant
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Allergan

An implant formulation for reduction of intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Elyxyb
celecoxib
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Promius Pharma

New oral solution formulation for treatment of acute migraine.

Eysuvis
loteprednol
Click here for more information
Kala Pharm.

An ophthalmic corticosteroid suspension for short-term symptomatic treatment of dry eye disease.

Fensolvi
leuprolide
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Tolmar Pharm.

New injectable formulation for pediatric patients with central precocious puberty.

Fintepla
fenfluramine
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Zogenix

New oral solution formulation for seizures associated with Dravet syndrome.

Gimoti
metoclopramide
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Evoke Pharma

New nasal spray formulation for diabetic gastroparesis.

Impeklo
clobetasol propionate
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Mylan

New lotion formulation for corticosteroid-responsive dermatoses.

Jelmyto
mitomycin
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UroGen Pharma

New formulation for pyelocalyceal use for upper tract urothelial cancer.

Kynmobi
apomorphine
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Sunovion Pharm.

A sublingual film formulation for intermittent treatment of “off” episodes in Parkinson’s disease.

Milprosa
progesterone
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Ferring Pharm.

A progesterone-containing vaginal insert to support embryo implantation and early pregnancy.

Monoferric
ferric derisomaltose
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Pharmacosmos

An intravenous iron replacement formulation for iron deficiency anemia.

Mycapssa
octreotide
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Chiasma

New oral capsule formulation for long-term maintenance treatment of acromegaly.

Onureg
azacitidine
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Celgene

New oral tablet formulation for acute myeloid leukemia.

Oriahnn
elagolix/estradiol/norethindrone
Click here for more information
AbbVie

A combination oral GnRH antagonist, estrogen, and progestin for fibroid-associated heavy menstrual bleeding in premenopausal women.

Phexxi
lactic acid/citric acid/potassium bitartrate
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Evofem

A vaginal gel formulation for on-demand prevention of pregnancy.

Procysbi
cysteamine bitartrate
Click here for more information
Horizon Therapeutics

New delayed-release capsules and oral granules for nephropathic cystinosis.

Qdolo
tramadol
Athena Bioscience

A new oral solution formulation for management of pain.

Tivicay PD
dolutegravir
Click here for more information
ViiV Healthcare

New tablets for oral suspension formulation.

Trijardy XR
empagliflozin/linagliptin/metformin
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Boehringer Ingelheim

New combination formulation for glycemic control in patients with type 2 diabetes.

Twirla
levonorgestrel/ethinyl estradiol
Click here for more information
Agile Therapeutics

New estrogen/progestin contraceptive patch.

Upneeq
oxymetazoline
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RVL Pharm.

A 0.1% ophthalmic solution for acquired blepharoptosis.

Valtoco
diazepam nasal spray
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Neurelis

New nasal spray formulation for acute treatment of seizure clusters and acute repetitive seizures.

Wynzora
calcipotriene/betamethasone dipropionate
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MC2 Therapeutics

New combination vitamin D analog and corticosteroid cream for plaque psoriasis.

Xaracoll
bupivacaine
Click here for more information
Innocoll

A new implant formulation for postsurgical analgesia following open inguinal hernia repair.

Xywav
calcium/magnesium/potassium/sodium oxybates
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Jazz Pharm.

New low-sodium formulation for narcolepsy.

Zilxi
minocycline
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Foamix Pharm.

A topical foam formulation for rosacea.

Brand/Generic Company Description
Belviq, Belviq XR
lorcaserin
Click here for more information
Eisai

Voluntary withdrawal from the market due to concerns about an increased occurrence of cancer seen in a clinical trial.

Zantac (and generics)
ranitidine
Click here for more information
Multiple

Withdrawal of all products (prescription and OTC) from the market due to safety concerns of the contaminant NDMA found in ranitidine products.