Health Canada drug approvals

This list includes new drugs, biosimilars and dosage forms approved (granted a Notice of Compliance) by Health Canada in 2024. Actual marketing dates can vary widely; check with the manufacturer/distributor. Click on the drug's description for its full product monograph.

December 2024 update
- Flucelvax (influenza vaccine, surface antigen, inactivated); new trivalent formulation
- Fluzone (influenza virus vaccine trivalent); trivalent formulation returns
- Fluzone High-Dose (influenza virus vaccine trivalent); trivalent formulation returns
- Jamteki I.V. (ustekinumab); new IV dosage form
- Omlyclo (omalizumab); first biosimilar to Xolair
- Otulfi / Otulfi I.V. (ustekinumab), a biosimilar to Stelara / Stelara I.V.
- Pexegra (pegfilgrastim); a biosimilar to Neulasta
- Pixxoscan (gadobutrol), an IV contrast agent for magnetic resonance imaging
- Ringza (segesterone acetate and ethinyl estradiol vaginal system), a vaginal ring for pregnancy prevention
- Vabomere (meropenem and vaborbactam), an IV antibiotic for treatment of carbapenem-resistant Gram-negative bacterial infections
- Veozah (fezolinetant) for moderate to severe vasomotor symptoms of menopause
- Vyloy (zolbetuximab) for unresectable/metastatic gastric or gastroesophageal junction adenocarcinoma

New drugs approved by Health Canada in 2024

*ABBREVIATIONS: IM–intramuscular; IV–intravenous; SC–subcutaneous

Brand name, generic name (Approval date; yr/mo/day)	Manufacturer or distributor	Route*	Description
Accrufer, ferric maltol	Kye Pharm	Oral	Treatment of iron deficiency anemia in adults unresponsive or intolerant to other oral iron preparations
Adheroza, trastuzumab (2024-08-20)	Accord Healthcare	IV	Biosimilar to Herceptin
Apretude, cabotegravir (2024-05-13)	ViiV Healthcare	Oral / IM	Injectable antiretroviral (with optional oral lead-in) for HIV pre-exposure prophylaxis
Armlupeg, pegfilgrastim (2024-08-16)	Lupin Pharma	SC	Biosimilar to Neulasta
Ayvakyt, avapritinib (2024-09-18)	Medison Pharma Canada	Oral	Tyrosine kinase inhibitor for advanced systemic mastocytosis
Awiqli, insulin icodec (2024-03-12)	Novo Nordisk	SC	Long-acting, once-weekly insulin for adults with diabetes
Cabtreo, clindamycin phosphate / adapalene / benzoyl peroxide (2024-08-14)	Bausch Health	Topical	Gel for treatment of acne in patients ≥ 12 years of age
Capvaxive, pneumococcal 21-valent conjugate vaccine (2024-07-15)	Merck	IM	Vaccine for prevention of invasive pneumococcal disease in adults
Casgevy, exagamglogene autotemcel (2024-09-23)	Vertex Pharmaceuticals	IV	Gene-edited therapy for sickle cell disease with recurrent vaso-occlusive crises, and transfusion-dependent β-thalassemia
Clorotekal, chloroprocaine hydrochloride B. (2024-08-22)	Braun of Canada	Intrathecal	spinal anesthetic for surgical procedures in adults
Combogesic IV, acetaminophen / ibuprofen (2024-02-02)	Biosyent	IV	Analgesic for short-term management of pain or as an adjunct to opioid analgesics
Comirnaty, COVID-19 mRNA vaccine, Omicron KP.2 variant (2024-09-24)	Pfizer	IM	Vaccine for active immunization against COVID-19
Cresemba, isavuconazole (2024-11-15)	Avir Pharma	oral	New dosage form: 40 mg capsule for treatment of invasive aspergillosis or invasive mucormycosis in children
Daybue, trofinetide (2024-10-11)	Acadia (US)/Innomar Strategies	oral	Analog of N-terminal tripeptide of insulin-like growth factor 1 for treatment of Rett syndrome
Ebglyss, lebrikizumab (2024-06-24)	Eli Lilly	SC	Interleukin inhibitor monoclonal antibody for moderate-to-severe atopic dermatitis
Eylea HD, aflibercept (2024-02-02)	Bayer	Intravitreal	New higher-strength (8 mg/0.07 mL) solution (compared to Eylea)
Ferinject, ferric carboxymaltose (2024-03-11)	Vifor (Switz)/ CSL Behring Canada	IV	Treatment of iron deficiency anemia
Flucelvax, influenza vaccine, surface antigen, inactivated (2024-12-03)	Seqirus	IM	New trivalent formulation (expected to replace quadrivalent formulation in 2025/26)
Fluzone, influenza virus vaccine trivalent Types A and B, split virion (2024-12-05)	Sanofi-Pasteur	IM	Trivalent formulation re-approved; originally approved in 2011 (expected to replace quadrivalent formulation in 2025/26)
Fluzone High-Dose, influenza virus vaccine trivalent (2024-12-05)	Sanofi Pasteur	IM	Trivalent formulation re-approved; originally approved in 2016 (expected to replace quadrivalent formulation in 2025/26)
Fruzaqla, fruquintinib (2024-09-10)	Takeda	Oral	Tyrosine kinase inhibitor for treatment of metastatic colorectal cancer
Imdelltra, tarlatamab (2024-09-11)	Amgen	IV	T-cell engager for extensive stage small cell lung cancer
Ixchiq, chikungunya vaccine (2024-06-20)	Valneva Canada	IM	Live, attenuated vaccine for prevention of disease caused by chikungunya virus in adults
Jamteki I.V., ustekinumab solution for IV infusion (2024-11-13)	Jamp Pharma	IV	New IV dosage form joins the existing SC injection (biosimilar to Stelara I.V.)
Jornay PM, methylphenidate (2024-11-13)	Ironshore Pharma/Knight Therapeutics	oral	Delayed-release and extended-release capsule taken nightly for ADHD in children 6–12 years of age
Jubbonti, denosumab (2024-02-16)	Sandoz	SC	Biosimilar to Prolia
Miebo, perfluorohexyloctane (2024-09-04)	Bausch & Lomb	ophthalmic	Solution for treatment of dry eye disease
Mounjaro KwikPen, tirzepatide injection (2024-09-24)	Eli Lilly	SC	New multidose prefilled pen in various strengths
mResvia (respiratory syncytial virus mRNA vaccine) (2024-11-06)	Moderna	IM	RSV vaccine for active immunization of adults ≥ 60 years of age
Myalepta, metreleptin (2024-01-17)	Chiesi (Italy) / Medison Pharma Canada	SC	Recombinant human leptin analog for treating complications of leptin deficiency in lipodystrophy
Niopeg, pegfilgrastim (2024-04-17)	Nora Pharma	SC	Biosimilar to Neulasta
Nordimet, methotrexate (2024-03-26)	Nordic (Netherlands)/Linepharma	SC	Single-use prefilled pens in various strengths for rheumatoid arthritis and psoriasis/psoriatic arthritis
Nuvaxovid, COVID-19 vaccine, recombinant protein, adjuvanted, Omicron JN.1 variant (2024-09-19)	Novavax	IM	Vaccine for active immunization against COVID-19
Ojjaara, momelotinib (24-11-08)	GSK	oral	Janus kinase inhibitor for treatment of splenomegaly/symptoms in adults with myelofibrosis
Okedi, risperidone (2024-03-21)	Lab Farm Rovi (Spain)	IM	Extended-release injectable suspension with two-syringe mixing system, given every 4 weeks
Olumiant, baricitinib (2024-01-26)	Eli Lilly	Oral	New 4 mg tablet for treatment of adults with severe alopecia areata
Omlyclo, omalizumab (2024-12-06)	Celltrion	SC	First biosimilar to Xolair
Okedi, risperidone (2024-03-21)	Lab Farm Rovi (Spain)	IM	Extended-release injectable suspension with two-syringe mixing system, given every 4 weeks
Opzelura, ruxolitinib (2024-10-11)	Incyte Corp/Innomar Strategies	Topical	JAK inhibitor cream for nonsegmental vitiligo, and mild to moderate atopic dermatitis
Otulfi / Otulfi I.V., ustekinumab (2024-12-30)	Fresenius Kabi	SC/IV	A biosimilar to Stelara / Stelara I.V.
Pexegra, pegfilgrastim (2024-12-13)	Jamp	SC	A biosimilar to Neulasta
Pixxoscan, gadobutrol (2024-11-29)	GE Healthcare Canada	IV	Contrast agent for magnetic resonance imaging
Plenvu, polyethylene glycol 3350 / sodium ascorbate / sodium sulfate anhydrous / ascorbic acid / sodium chloride / potassium chloride (2024-08-16)	Bausch Health	Oral	Powder for oral solution; an osmotic laxative colonoscopy preparation solution for adults
Pyzchiva / Pyzchiva I.V., ustekinumab (2024-08-07)	Sandoz	SC / IV	Biosimilar to Stelara / Stelara I.V.
Ringza, segesterone acetate and ethinyl estradiol vaginal system (2024-12-18)	Duchesnay	Vaginal	A progestin/estrogen vaginal ring for pregnancy prevention
Rybelsus, semaglutide, optimized formulation (2024-10-08)	Novo Nordisk	Oral	New tablet formulation with an absorption enhancer (1.5 mg, 4 mg and 9 mg strengths)
Spikevax, COVID-19 mRNA vaccine, Omicron KP.2 variant (2024-09-17)	Moderna	IM	Active immunization against COVID-19
Steqeyma / Steqeyma I.V., ustekinumab (2024-07-30)	Celltrion	SC / IV	Biosimilar to Stelara / Stelara I.V.
Talvey, talquetamab (2024-04-30)	Janssen (now Johnson & Johnson)	SC	Antineoplastic monoclonal antibody for relapsed or refractory multiple myeloma
Tecentriq SC, atezolizumab (2024-03-13)	Hoffmann-La Roche	SC	New SC format for patients who wish to transition from an IV to SC dosage form
Tibsovo, ivosidenib (2024-07-19)	Servier	Oral	Mutant IDH1 enzyme inhibitor for acute myeloid leukemia or metastatic cholangiocarcinoma
Truqap, capivasertib (2024-01-26)	AstraZeneca	Oral	AKT (serine/threonine kinase) inhibitor for HR+, HER2-negative locally advanced or metastatic breast cancer
Tyenne, tocilizumab (2024-10-11)	Fresenius Kabi Canada	IV	A biosimilar to Actemra
Vabomere, meropenem and vaborbactam (2024-12-20)	Xediton	IV	A carbapenem antibiotic and beta-lactamase inhibitor for treatment of carbapenem-resistant Gram-negative bacterial infections
Velsipity, etrasimod (2024-01-31)	Pfizer	Oral	Sphingosine 1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis
Veozah, fezolinetant (2024-12-02)	Astellas	Oral	Nonhormonal selective NK3 receptor antagonist for moderate to severe vasomotor symptoms of menopause
Voranigo, vorasidenib (2024-08-27)	Servier	Oral	IDH1 / IDH2 enzyme inhibitor for Grade 2a astrocytoma or oligodendroglioma
Voydeya, danicopan (2024-07-19)	Alexion	Oral	Complement inhibitor; add-on therapy in paroxysmal nocturnal hemoglobinuria
Vyloy, zolbetuximab (2024-12-13)	Astellas	IV	Monoclonal antibody for first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric orgastroesophageal junction adenocarcinoma
Wainua, eplontersen (2024-06-19)	AstraZeneca	SC	Antisense oligonucleotide for hereditary transthyretin-mediated amyloidosis
Winrevair, sotatercept (2024-08-28)	Merck	SC	Activin signalling inhibitor for treatment of pulmonary arterial hypertension
Wyost, denosumab (2024-03-01)	Sandoz	SC	Biosimilar to Xgeva
Xenpozyme, olipudase alfa (2024-02-28)	Sanofi-aventis	IV	Enzyme replacement therapy for long-term treatment of non-CNS manifestations of acid sphingomyelinase deficiency
Zilbrysq, zilucoplan (2024-07-11)	UCB Canada	SC	Complement C5 inhibitor for generalized myasthenia gravis
Zoryve, roflumilast (2024-10-17)	Arcutis Canada	Topical	New dosage form: 0.3% foam for seborrheic dermatitis in patients ≥ 9 years of age

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Health Canada drug approvals

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