New Drugs

Brand/Generic Company Description
Abrysvo
RSV vaccine
Pfizer

Vaccine for immunization during pregnancy to prevent RSV disease in infants; also used to prevent RSV disease in individuals ≥ 60 years of age.

ACAM2000
smallpox vaccine
Emergent BioSolutions Canada

Vaccinia virus vaccine for active immunization against smallpox in high-risk persons.

Alhemo
concizumab
Novo Nordisk Canada

A new anti-tissue factor pathway inhibitor antibody for hemophilia B.

Amvuttra
vutrisiran
Alnylam Netherlands/Innomar Strategies

SC transthyretin-directed small interfering RNA for polyneuropathy in hereditary transthyretin-mediated amyloidosis.

Asparlas
calaspargase pegol
Servier

IV enzyme that depletes plasma asparagine for treatment of acute lymphoblastic leukemia.

Beqvez
fidanacogene elaparvovec
Pfizer

Gene therapy for treatment of moderately severe to severe hemophilia B in adults.

Beyfortus
nirsevimab
AstraZeneca/Sanofi

A new long-acting antibody for the prevention of respiratory syncytial virus (RSV) in neonates, infants, and children up to 24 months of age.

Bylvay
odevixibat
Medison Pharma

Oral ileal bile acid transporter inhibitor for treating pruritus in progressive familial intrahepatic cholestasis.

Carvykti
ciltacabtagene autoleucel
Janssen

A new B-cell maturation antigen (BCMA)-directed T-cell IV immunotherapy for adults with multiple myeloma.

Columvi
glofitamab
Hoffmann-La Roche

A new CD20/CD-3 binding monoclonal antibody for B-cell lymphoma.

Comirnaty Omicron XBB.1.5
COVID-19 mRNA vaccine, monovalent
Pfizer

Vaccine for active immunization against COVID-19 in individuals 6 months of age or older.

Doptelet
avatrombopag
Swedish Orphan/Sobi Canada

Oral thrombopoietin receptor agonist for thrombocytopenia in chronic liver disease or chronic immune thrombocytopenia.

Elrexfio
elranatamab
Pfizer

SC BCMA-directed monoclonal antibody for relapsed/refractory multiple myeloma.

Epidiolex
cannabidiol
GW Research (UK)/Jazz Pharm Canada

Cannabinoid oral solution for adjunctive therapy in specific types of seizures.

Epkinly
epcoritamab
AbbVie

SC CD20-directed CD3 T-cell engager mAb for lymphoma.

Evkeeza
evinacumab
Ultragenyx (US)/Innomar Strategies

Angiopoietin-like 3 (ANGPTL3) protein inhibitor mAb for homozygous familial hypercholesterolemia.

Hemgenix
etranacogene dezaparvovec
CSL Behring

IV gene therapy for routine prophylaxis to prevent/reduce bleeding episodes in hemophilia B.

Imcivree
setmelanotide
Rhythm Pharmaceuticals

A new MC4 receptor agonist for weight management in patients with Bardet-Biedl syndrome or other specified genetic conditions.

Jamteki
ustekinumab
Jamp Pharma

SC selective immunomodulating agent; biosimilar to Stelara.

Kengrexal
cangrelor
Methapharm

A new IV direct P2Y12 platelet receptor inhibitor for patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).

Litfulo
ritlecitinib
Pfizer

Oral JAK3/TEC kinase inhibitor for severe alopecia areata.

Livmarli
maralixibat
Mirum Pharm (US)

Oral ileal bile acid transporter inhibitor for cholestatic pruritus in Alagille syndrome.

Nurtec ODT
rimegepant
Pfizer

Oral CGRP antagonist for acute migraine in adults.

Nuvaxovid XBB.1.5
COVID-19 vaccine
Novavax

Recombinant protein, adjuvanted vaccine to prevent COVID-19.

Omvoh
mirikizumab
Eli Lilly

IV/SC interleukin-23 p19 antagonist for moderate to severe ulcerative colitis.

Onakta
tirbanibulin
Avir Pharma

A new topical microtubule inhibitor for actinic keratosis on the face or scalp.

Opdualag
nivolumab / relatlimab
Bristol-Myers Squibb

PD-1 inhibitor/LAG-3 checkpoint inhibitor mAb combination for unresectable or metastatic melanoma.

Orgovyx
relugolix
Sumitomo Pharma Canada

GnRH receptor antagonist for advanced prostate cancer.

Panenza
pandemic influenza vaccine (H1N1)
Sanofi Pasteur

Prophylaxis of influenza in an officially declared pandemic situation.

Pronextica Liquid
alpha1-proteinase inhibitor (human)
Grifols Canada

Alpha1-antitrypsin replenisher for long-term use in patients with alpha1-antitrypsin deficiency and emphysema.

Quviviq
daridorexant
Idorsia/Innomar Strategies

A new oral dual orexin receptor antagonist for insomnia in adults.

Ranopto
ranibizumab
Teva

Biosimilar to Lucentis.

Sibboran
landiolol
Trimedic

IV beta-blocker for short-term reduction of ventricular rate in patients with supraventricular tachycardia.

Sogroya
somapacitan
Novo Nordisk

SC human growth hormone analogue for growth failure in children or growth hormone deficiency in adults.

Spevigo
spesolimab
Boehringer Ingelheim Canada

A new interleukin-36 inhibitor for generalized pustular psoriasis.

SpikeVax XBB.1.5
COVID-19 mRNA vaccine, monovalent (XBB.1.5 variant)
Moderna

Vaccine for active immunization against COVID-19 in individuals 6 months of age or older.

Tembexa
brincidofovir
Emergent BioSolutions Canada

Oral antiviral for treatment of human smallpox disease.

Trikafta
elexacaftor/ tezacaftor/ivacaftor
Vertex

New granule formulation for use in children 2 years of age or older.

Uplizna
inebilizumab
Horizon Therapeutics

CD19-directed cytolytic mAb for neuromyelitis optica spectrum disorder.

Vaxchora
cholera vaccine
Emergent BioSolutions

A new oral, live-attenuated vaccine against diarrheal disease caused by Vibrio cholerae for patients traveling to cholera-affected countries.

Vegzelma
bevacizumab
Celltrion

A biosimilar to Avastin.

Verquvo
vericiguat
Bayer

A new oral soluble guanylate cyclase (sGC) stimulator for symptomatic heart failure with reduced ejection fraction (HFrEF) in adults.

Vyalev
foslevodopa/foscarbidopa
AbbVie

A new prodrug of levodopa/carbidopa for motor fluctuation in patients with advanced Parkinson’s disease.

Xcopri
cenobamate
Endo/Paladin Labs

Antiepileptic for adjunctive therapy in partial-onset seizures in adults.

Brand/Generic Company Description
Absorica LD
isotretinoin
Sun Pharma

Oral retinoid micronized formulation for severe/recalcitrant acne.

Calquence
acalabrutinib maleate
AstraZeneca

New tablet dosage form that does not interact with gastric acid reducing agents

Erleada
apalutamide
Janssen

New 240 mg tablet strength for single-tablet daily dosing in prostate cancer.

Ferriprox MR
deferiprone
Chiesi Canada

New extended-release tablet that allows for twice daily dosing.

Levodexa
dexamethasone/levofloxacin
Xediton Pharma

Ophthalmic corticosteroid/quinolone combo for inflammation/infection associated with cataract surgery.

Mekinist
trametinib
Novartis

New powder for oral solution for use in children.

Noyada
captopril
Ethypharm

Oral ACEI solution for hypertension, heart failure and diabetic nephropathy.

Quillivant ER
methylphenidate
Kye Pharmaceuticals

First once-daily methylphenidate ER chewable tablet and ER oral suspension formulations for ADHD in Canada.

Rinvoq
upadacitinib
AbbVie

New 45 mg extended-release tablet for induction therapy in ulcerative colitis.

Tafinlar
dabrafenib
Novartis

New 10 mg tablet for oral suspension.

Xywav
calcium, magnesium, potassium, sodium oxybate
Jazz Pharmaceuticals

A new oral solution for cataplexy in patients with narcolepsy (mechanism unknown).

Zoryve
roflumilast
Arcutis Biotherapeutics

New topical cream for plaque psoriasis.

Brand/Generic Company Description
Idhifa
enasidenib
Celegene

Withdrawn due to failure to demonstrated improved overall survival compared to conventional regimens.

Jcovden
COVID-19 vaccine (Ad26.COV2-S [recombinant])
Janssen

Company business decision to voluntarily withdraw the product.