New Drugs

Brand/Generic Company Description
Alunbrig
brigatinib
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Ariad Pharm.

A kinase inhibitor for a certain type of non-small cell lung cancer.

Austedo
deutetrabenazine
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Teva

A VMAT2 inhibitor for chorea associated with Huntington's disease.

Bavencio
avelumab
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EMD Serono

A monoclonal antibody for metastatic Merkel cell carcinoma and urothelial carcinoma.

Baxdela
delafloxacin
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Melinta Therapeutics

A fluoroquinolone antibiotic for acute bacterial skin/skin structure infections.

Bevyxxa
betrixaban
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Portola Pharm.

A factor Xa inhibitor for prophylaxis of venous thromboembolism (VTE) due to restricted mobility or other VTE risk factors during hospitalization.

Brineura
cerliponase alfa
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BioMarin

An enzyme replacement therapy to slow loss of walking ability in pediatric patients with a form of Batten disease.

Dupixent
dupilumab
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Regeneron

An IL-4RA antagonist for moderate to severe eczema (atopic dermatitis).

Emflaza
deflazacort
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Marathon Pharm.

An oral corticosteroid for Duchenne muscular dystrophy.

Haegarda
C1 esterace inhibitor
CSL Behring

A C1 esterace inhibitor (human) to prevent hereditary angioedema attacks.

Idhifa
enasidenib
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Celgene

An oral isocitrate dehydrogenase-2 inhibitor for acute myeloid leukemia.

Imfinzi
durvalumab
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AstraZeneca

A monoclonal antibody for advanced or metastatic urothelial carcinoma.

Ingrezza
valbenazine
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Neurocrine Biosciences

A VMAT2 inhibitor for adults with tardive dyskinesia.

Kevzara
sarilumab
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Sanofi-Aventis

An IL-6 receptor antagonist for moderate to severe rheumatoid arthritis.

Kisqali
ribociclib
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Novartis

A kinase inhibitor for postmenopausal women with advanced breast cancer.

Mavyret
glecaprevir/pibrentasvir
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AbbVie

A fixed-dose combination tablet for chronic hepatitis C infection.

Nerlynx
neratinib
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Puma Biotechnology

An oral kinase inhibitor extended adjuvant therapy for breast cancer.

Ocrevus
ocrelizumab
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Genentech

A monoclonal antibody for relapsing or primary progressive forms of multiple sclerosis.

Odactra
house dust mite allergen extract
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Merck

A sublingual tablet allergen extract for house dust mite-induced allergic rhinitis.

Parsabiv
etelcalcetide
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Amgen

A calcium-sensing receptor agonist for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

Radicava
edaravone
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MT Pharma America

An intravenous treatment for amyotrophic lateral sclerosis (ALS).

Rebinyn
Factor IX, glycoPEGylated
Novo Nordisk

A coagulation factor for management of bleeding in patients with hemophilia B.

Renflexis
infliximab-abda
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Merck

A biosimilar to Remicade for multiple indications.

Rituxan Hycela
rituximab/hyaluronidase
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Genentech

New formulation for certain lymphomas and chronic lymphocytic leukemia.

Rydapt
midostaurin
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Novartis

A kinase inhibitor for patients with acute myeloid leukemia (AML) and other rare blood disorders.

Siliq
brodalumab
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Valeant

An IL-17RA antagonist for moderate to severe plaque psoriasis.

Symproic
naldemedine
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Shionogi

An opioid antagonist for opioid-induced constipation.

Tremfya
guselkumab
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Janssen Biotech

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

Trulance
plecanatide
Synergy Pharm.

A guanylate cyclase-C agonist for chronic idiopathic constipation.

Tymlos
abaloparatide
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Radius Health

A human parathyroid hormone related peptide analog for postmenopausal women with osteoporosis and high fracture risk.

Vosevi
sofosbuvir/velpatasvir/voxilaprevir
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Gilead Sciences

An oral fixed-dose combination product for chronic hepatitis C infection.

Xadago
safinamide
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US WorldMeds

An MAO-B inhibitor for Parkinson's patients experiencing "off" episodes.

Xermelo
telotristat
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Lexicon Pharm.

An oral tryptophan hydroxylase inhibitor for carcinoid syndrome diarrhea.

Zejula
niraparib
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Tesaro

A PARP inhibitor for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Brand/Generic Company Description
Airduo Respiclick
fluticasone/salmeterol
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Teva

New oral inhalation combination corticosteroid and LABA for treatment of asthma.

Armonair Respiclick
fluticasone
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Teva

New oral inhalation corticosteroid for maintenance treatment of asthma.

Arymo ER
morphine
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Egalet US

New extended-release tablets for severe pain.

Corphedra
ephedrine
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Par

New injectable formulation for treatment of hypotension during anesthesia.

Cotempla XR-ODT
methylphenidate
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Neos Therapeutics

New extended-release orally disintegrating tablet formulation for ADHD.

Endari
L-glutamine
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Emmaus Medical

New oral powder formulation to reduce complications associated with sickle cell disease.

Gleolan
aminolevulinic acid hydrochloride
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NXDC

New oral solution formulation optical imaging agent.

Jadenu Sprinkle
deferasirox
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Novartis

New sprinkle granules formulation for treatment of chronic iron overload.

Minolira
minocycline
Promius Pharma

New extended-release tablet formulation for non-nodular moderate to severe acne.

Mydayis
amphetamine, mixed salts
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Shire US

New CNS stimulant formulation for ADHD.

Nityr
nitisinone
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Cycle Pharm.

New tablet formulation for hereditary tyrosinemia type 1.

Noctiva
desmopressin
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Allergan

New nasal spray formulation for nocturia due to nocturnal polyuria.

Qtern
dapagliflozin/saxagliptin
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AstraZeneca

A new combination SGLT-2 inhibitor and DPP-4 inhibitor for type 2 diabetes.

Rhofade
oxymetazoline
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Allergan

New topical cream formulation for facial erythema associated with rosacea.

Roxybond
oxycodone
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Inspirion Delivery Sciences

A new opioid analgesic formulation for management of severe pain.

Symjepi
epinephrine
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Adamis Pharm.

New pre-filled syringe injection formulation for emergency treatment of allergic reactions.

Tepadina
thiotepa
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Adienne

New injectable formulation for intravenous, intracavitary, or intravesical use.

Triptodur
triptorelin
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Arbor Pharm.

New extended-release IM formulation for central precocious puberty.

Vantrela ER
hydrocodone
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Teva

New extended-release tablets for severe pain.

Vyxeos
daunorubicin/cytarabine
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Jazz Pharm.

New liposomal combination formulation for certain types of acute myeloid leukemia.

Xatmep
methotrexate
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Silvergate Pharm.

New oral solution formulation for pediatric patients with acute lymphoblastic leukemia (ALL) and juvenile arthritis.

Zerviate
cetirizine
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Nicox Ophthalmics

New ophthalmic solution (0.24%) formulation for ocular itching associated with allergic conjunctivitis.

Zypitamag
pitavastatin
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Zydus Pharm.

New magnesium salt formulation of pitavastatin for hyperlipidemia.

Brand/Generic Company Description
Opana ER
oxymorphone
Endo

Withdrawal from the market requested by the FDA due to concern the benefits of the drug no longer outweigh its risks.