Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review

This list is current as of: 2025-07-31.

An Excel version of the updated SUR List is available from the Overview page.

Submissions currently under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Year, Month Submission was Accepted into Review Company Name (available for submissions accepted into review on or after October 1, 2018) Submission 'Class' (if applicable) (available for submissions accepted into review on or after October 1, 2018)
Acalabrutinib maleate Antineoplastic agents 2024-11 AstraZeneca Canada Inc Part of an 'aligned review' with a health technology assessment organization
Adalimumab Immunosuppressants 2024-09 JAMP Pharma Corporation Biosimilar
Alirocumab Lipid modifying agents 2024-12 Sanofi-Aventis Canada Inc Not applicable
Antihemophilic factor (recombinant, B-domain deleted, pegylated) Antihemorrhagics 2024-12 Bayer Inc Not applicable
Avapritinib Antineoplastic agents 2025-05 Blueprint Medicines Corporation

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Belimumab Immunosuppressants 2023-11 GlaxoSmithKline Inc Not applicable
Bimekizumab Immunosuppressants 2024-06 UCB Canada Inc Part of an 'aligned review' with a health technology assessment organization
Chikungunya virus live-attentuated Vaccines 2024-10 Valneva Austria GmbH Not applicable
Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, 35B, deOAc15B Vaccines 2024-11 Merck Canada Inc Not applicable
Daratumumab Antineoplastic agents 2025-01 Janssen Inc Not applicable
Darolutamide Endocrine therapy 2024-11 Bayer Inc Part of an 'aligned review' with a health technology assessment organization
Dupilumab Other dermatological preparations 2024-06 Sanofi-Aventis Canada Inc Not applicable
Dupilumab Other dermatological preparations 2025-01 Sanofi-Aventis Canada Inc Not applicable
Durvalumab Antineoplastic agents 2024-01 AstraZeneca Canada Inc Not applicable
Durvalumab Antineoplastic agents 2025-07 AstraZeneca Canada Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Efgartigimod alfa Immunsuppressants 2025-01 Argenx BV Part of an 'aligned review' with a health technology assessment organization
Enoxaparin sodium Antithrombotic agents 2024-12 Sanofi-Aventis Canada Inc Not applicable
Finerenone Diuretics 2025-03 Bayer Inc Part of an 'aligned review' with a health technology assessment organization
Follitropin alfa, lutropin alfa Sex hormones and modulators of the genital system 2024-11 EMD Serono a Division of EMD Inc. Canada Not applicable
Fremanezumab Analgesics 2025-04 Teva Canada Limited Not applicable
Glecaprevir, pibrentasvir Antivirals for systemic use 2025-06 Abbvie Corporation Being reviewed under the Priority Review Policy
Glofitamab Antineoplastic agents 2024-10 Hoffmann-la Roche Limited Part of an 'aligned review' with a health technology assessment organization
Guselkumab Immunosuppressants 2024-06 Janssen Inc Not applicable
Guselkumab Immunosuppressants 2025-01 Janssen Inc Not applicable
Guselkumab Immunosuppressants 2025-01 Janssen Inc Not applicable
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines 2025-04 BGP Pharma ULC Not applicable
Inebilizumab Immunosuppressants 2025-07 Amgen Canada Inc Not applicable
Iptacopan hydrochloride Immunosuppressants 2025-07 Novartis Pharmaceuticals Canada Inc Part of an 'aligned review' with a health technology assessment organization
Leuprolide acetate Endocrine therapy 2025-01 Abbvie Corporation Not applicable
Macitentan Antihypertensives 2024-02 Janssen Inc Not applicable
Maralixibat chloride Bile and liver therapy 2025-04 Mirum Pharmaceuticals, Inc. Part of an 'aligned review' with a health technology assessment organization
Meningococcal groups A, C, Y, and W polysaccharide-tetanus toxoid conjugate Vaccines 2025-05 Sanofi Pasteur Limited Not applicable
Mepolizumab Drugs for obstructive airway diseases 2025-01 GlaxoSmithKline Inc Part of an 'aligned review' with a health technology assessment organization
Nivolumab Antineoplastic agents 2024-03 Bristol-Myers Squibb Canada Not applicable
Obinutuzumab Antineoplastic agents 2025-03 Hoffmann-la Roche Limited

Not applicable

Part of an 'aligned review' with a health technology assessment organization

Pembrolizumab Antineoplastic agents 2025-02 Merck Canada Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Roflumilast Antipsoriatics 2025-01 Arcutis Canada, Inc. Not applicable
RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) Vaccines 2025-03 Moderna Biopharma Canada Corporation Not applicable
RSV subgroups A, B stabilized prefusion F protein Vaccines 2024-12 Pfizer Canada ULC Not applicable
Ruxolitinib phosphate Other dermatological preparations 2024-12 Incyte Corporation Not applicable
Selumetinib sulfate Antineoplastic agents 2025-05 Alexion Pharma GmbH Not applicable
Semaglutide Drugs used in diabetes 2024-02 Novo Nordisk Canada Inc Not applicable
Semaglutide Drugs used in diabetes 2024-07 Novo Nordisk Canada Inc Not applicable
Semaglutide Drugs used in diabetes 2025-03 Novo Nordisk Canada Inc Not applicable
Semaglutide Drugs used in diabetes 2025-04 Novo Nordisk Canada Inc Not applicable
Semaglutide Drugs used in diabetes 2025-04 Novo Nordisk Canada Inc Being reviewed under the Priority Review Policy
Sotatercept Antihypertensives 2025-06 Merck Canada Inc Being reviewed under the Priority Review Policy
Tafasitamab Antineoplastic agents 2025-06 Incyte Corporation Part of an 'aligned review' with a health technology assessment organization
Tenecteplase Antithrombotic agents 2024-08 Hoffmann-la Roche Limited Not applicable
Tezepelumab Drugs for obstructive airway diseases 2025-04 AstraZeneca Canada Inc Part of an 'aligned review' with a health technology assessment organization
Tirzepatide Drugs used in diabetes 2025-02 Eli Lilly Canada Inc Not applicable
Trastuzumab deruxtecan Antineoplastic agents 2024-12 AstraZeneca Canada Inc Part of an 'aligned review' with a health technology assessment organization
Upadacitinib Immunosuppressants 2024-10 Abbvie Corporation Not applicable
Ustekinumab Immunosuppressants 2025-07 Fresenius Kabi Canada Ltd Biosimilar
Vutrisiran sodium Other nervous system drugs 2025-02 Alnylam Netherlands B.V. Part of an 'aligned review' with a health technology assessment organization

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