New Drugs

Brand/Generic Company Description
Aimovig
erenumab-aooe
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Amgen

A calcitonin gene-related peptide receptor antagonist to prevent migraine.

Ajovy
fremanezumab-vfrm
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Teva

A calcitonin gene-related peptide receptor antagonist to prevent migraine.

Akynzeo
fosnetupitant/palonosetron
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Helsinn

An injectable formulation for prevention of chemo-induced nausea and vomiting.

Andexxa
coagulation factor Xa
Portola Pharm

Anticoagulation reversal agent for rivaroxaban and apixaban.

Annovera
segesterone/ethinyl estradiol
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Population Council

A progestin/estrogen contraceptive vaginal system to prevent pregnancy.

Biktarvy
bictegravir/ emtricitabine/tenofovir alafenamide
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Gilead Sciences

A combination drug for treatment of HIV-1 infection.

Braftovi
encorafenib
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Array BioPharma

A kinase inhibitor for metastatic melanoma.

Copiktra
duvelisib
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Verastem

A kinase inhibitor for certain types of leukemia and lymphomas.

Crysvita
burosumab-twza
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Ultragenyx

A fibroblast growth factor 23 blocking antibody for X-linked hypophosphatemia.

Delstrigo
doravirine/lamivudine/tenofovir disoproxil
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Merck

A combination antiretroviral for HIV-1 infection.

Diacomit
stiripentol
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Biocodex

An anticonvulsant for patients with Dravet syndrome who also take clobazam.

Doptelet
avatrombopag
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Dova Pharm.

A thrombopoietin receptor agonist for thrombocytopenia in patients with chronic liver disease prior to undergoing a procedure.

Emgality
galcanezumab-gnlm
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Lilly

A calcitonin-gene related peptide receptor antagonist to prevent migraine.

Epidiolex
cannabidiol
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Greenwich Biosciences

A CBD oral solution for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.

Erleada
apalutamide
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Janssen

An androgen receptor inhibitor for non-metastatic, castration-resistant prostate cancer.

Fulphila
pegfilgrastim-jmdb
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Mylan

The first biosimilar to Neulasta.

Galafold
migalastat
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Amicus Therapeutics

An alpha-Gal A pharmacological chaperone for patients with Fabry disease.

Ilumya
tildrakizumab-asmn
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Merck

An interleukin-23 antagonist for moderate-to-severe plaque psoriasis.

Krintafel
tafenoquine
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GSK

An antimalarial to prevent relapse of P. vivax infection.

Libtayo
cemiplimab-rwlc
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Regeneron

A monoclonal antibody for metastatic cutaneous squamous cell carcinoma.

Lokelma
sodium zirconium cyclosilicate
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AstraZeneca

A potassium binder for hyperkalemia.

Lucemyra
lofexidine
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US WorldMeds

An alpha-2 agonist to reduce opioid withdrawal symptoms.

Lumoxiti
moxetumomab pasudotox-tdfk
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AstraZeneca

A monoclonal antibody for hairy cell leukemia.

Lutathera
lutetium Lu 177 dotatate
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Advanced Accelerator Applic.

A radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors.

Mektovi
binimetinib
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Array BioPharma

A kinase inhibitor for metastatic melanoma.

Moxidectin
moxidectin
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Medicines Devlopment

An anthelmintic for onchocerciasis.

Mulpleta
lusutrombopag
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Shionogi

A thrombopoietin receptor agonist for use in chronic liver disease patients to treat thrombocytopenia prior to undergoing a procedure.

Nuzyra
omadacycline
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Paratek Pharm.

An oral/injectable tetracycline class antibiotic for community-acquired pneumonia and skin infections.

Olumiant
baricitinib
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Lilly

An oral Janus kinase inhibitor for rheumatoid arthritis.

Omegaven
fish oil triglycerides
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Fresenius Kabi

An injectable source of calories/fatty acids for pediatric patients with parenteral nutrition-associated cholestasis.

Onpattro
patisiran
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Alnylam

An injectable agent for polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Orilissa
elagolix
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AbbVie

A gonadotropin-releasing hormone receptor antagonist for pain associated with endometriosis.

Oxervate
cenegermin-bkbj
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Dompé U.S.

A human nerve growth factor for neurotrophic keratitis.

Palynziq
pegvaliase-pqpz
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BioMarin Pharm.

An enzyme to reduce blood phenylalanine levels in patients with phenylketonuria.

Pifeltro
doravirine
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Merck

An NNRTI antiretroviral agent for HIV-1 infection.

Poteligeo
mogamulizumab-kpkc
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Kyowa Kirin

A monoclonal antibody for advanced mycosis fungoides or Sézary syndrome.

Retacrit
epoetin alfa-epbx
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Hospira

A biosimilar to Epogen/Procrit.

Seysara
sarecycline
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Allergan

An oral tetracycline-class drug for moderate to severe acne.

Symdeko
tezacaftor/ivacaftor
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Vertex Pharm.

A combination formulation for cystic fibrosis in patients with a specific gene mutation.

Takhzyro
lanadelumab-flyo
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Dyax Corp.

A monoclonal antibody to prevent attacks of hereditary angioedema.

Tavalisse
fostamatinib
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Rigel Pharm.

A kinase inhibitor for chronic immune thrombocytopenia.

Tegsedi
inotersen
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Ionis Pharm.

A transthyretin-directed antisense oligonucleotide for polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Tibsovo
ivosidenib
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Agios Pharm.

An IDH1 inhibitor for advanced acute myeloid leukemia.

Tpoxx
tecovirimat
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Siga Technologies

A new drug for the treatment of human smallpox disease.

Trogarzo
ibalizumab-uiyk
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Thera Technologies

An antiretroviral for patients with multidrug resistant HIV-1 infection.

Vizimpro
dacomitinib
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Pfizer

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

Xerava
eravacycline
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Tetraphase Pharm.

A tetracycline class antibiotic for complicated intra-abdominal infections.

Zemdri
plazomicin
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Achaogen

An aminoglycoside antibiotic for complicated UTI including pyelonephritis.

Brand/Generic Company Description
Altreno
tretinoin
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Valeant Pharm.

A topical lotion formulation for acne vulgaris.

Apadaz
benzhydrocodone/acetaminophen
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KemPharm

New combination formulation for short-term management of acute pain.

Arakoda
tafenoquine
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60 Degrees Pharm.

A lower dose formulation for prophylaxis of malaria.

Arikayce
amikacin
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Insmed

New liposome suspension for oral inhalation to treat Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen.

Aristada Initio
aripiprazole
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Alkermes

New single-dose pre-filled syringe for use when initiating treatment with Aristada.

Cassipa
buprenorphine/naloxone
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Teva

New higher-strength sublingual film (16 mg buprenorphine/4 mg naloxone) for maintenance treatment of opioid dependence.

Cequa
cyclosporine
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Sun Pharm.

New higher strength ophthalmic formulation of cyclosporine to increase tear production in patients with dry eyes.

Cimduo
lamivudine/tenofovir disoproxil fumarate
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Mylan

New combination formulation for HIV-1 infection.

Consensi
amlodipine/celecoxib
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Kitov Pharma

New CCB/NSAID combination formulation for patients with hypertension and osteoarthritis.

Dexycu
dexamethasone
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Icon Bioscience

New intraocular suspension formulation for postoperative inflammation.

Firvanq
vancomycin
CurtisPharma

An oral solution formulation for C. difficile-associated diarrhea and enterocolitis caused by S. aureus (including MRSA).

Imvexxy
estradiol
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TherapeuticsMD

New vaginal insert estrogen formulation for dyspareunia due to menopause.

Inveltys
loteprednol
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Kala Pharm.

A higher strength ophthalmic corticosteroid for post-op inflammation and pain after ocular surgery.

Jornay PM
methylphenidate
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Ironshore Pharm.

A CNS stimulant for ADHD to be taken in the evening.

Jynarque
tolvaptan
Otsuka America

New formulation of tolvaptan to slow kidney function decline in patients at risk of progressing autosomal dominant polycystic kidney disease.

Nocdurna
desmopressin
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Ferring

New sublingual tablet formulation for nocturia.

Osmolex ER
amantadine
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Vertical Pharm.

New extended-release tablet formulation.

Perseris
risperidone
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Indivior

New extended-release injectable formulation for subcutaneous administration.

Plenvu
PEG 3350 plus electrolytes
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Norgine

A lower-volume, 1-liter bowel prep for colonoscopies.

Qbrexza
glycopyrronium
Dermira

An anticholinergic topical treatment for axillary hyperhidrosis.

Symfi
efavirenz/lamivudine/tenofovir disoproxil fumarate
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Mylan

New combination formulation for HIV-1 infection. Contains a higher strength of efavirenz/tablet vs Symfi Lo.

Symfi Lo
efavirenz/lamivudine/tenofovir disoproxil fumarate
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Mylan

New combination formulation for HIV-1 infection.

Symtuza
darunavir/cobicistat/emtricitabine/tenofovir alafenamide
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Janssen

New combination formulation for HIV-1 infection.

Tiglutik
riluzole
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ITF Pharma

New oral suspension formulation for amyotrophic lateral sclerosis (ALS).

Xelpros
latanoprost
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Sun Pharm.

New ophthalmic emulsion formulation for open-angle glaucoma and ocular hypertension.

Xyosted
testosterone enanthate
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Antares

A subcutaneous androgen for testosterone replacement therapy.

Yonsa
abiraterone
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Sun Pharm.

New lower strength formulation for metastatic castration-resistant prostate cancer.

Ztlido
lidocaine
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Scilex Pharm.

New topical patch formulation for post-herpetic neuralgia pain.

Brand/Generic Company Description
Zinbryta
Daclizumab
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Biogen/AbbVie

The manufacturer is removing the drug from the worldwide market due to safety concerns, including reports of severe liver damage and immune-related conditions.