Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review
This list is current as of: 2024-08-31.
An Excel version of the updated SUR List is available from the Overview page.
| 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) |
|---|---|---|---|---|
| Adalimumab | Immunosuppressants | 2024-03 | Samsung Bioepis Co., Ltd |
Biosimilar |
| Aflibercept | Ophthalmologicals | 2023-09 | Bayer Inc |
Not applicable |
| Amifampridine phosphate | Other nervous system drugs | 2024-08 | Kye Pharmaceuticals Inc |
Not applicable |
| Amivantamab | Antineoplastic agents | 2024-03 | Janssen Inc |
Not applicable |
| Aripiprazole | Psycholeptics | 2022-09 | Otsuka Pharmaceutical Co Ltd |
Part of an 'aligned review' with a health technology assessment organization |
| Belimumab | Immunosuppressants | 2023-11 | GlaxoSmithKline Inc |
Not applicable |
| Belzutifan | Antineoplastic agents | 2024-02 | Merck Canada Inc |
Not applicable |
| Benralizumab | Drugs for obstructive airway diseases | 2024-04 | AstraZeneca Canada Inc |
Not applicable |
| Bimekizumab | Immunosuppressants | 2024-06 | UCB Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Blinatumomab | Antineoplastic agents | 2024-02 | Amgen Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Cabozantinib malate | Antineoplastic agents | 2023-11 | Ipsen Biopharmaceuticals Canada Inc |
Not applicable |
| Daratumumab | Antineoplastic agents | 2024-05 | Janssen Inc |
Being reviewed under the Priority Review Policy |
| Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 2024-05 | ALK – Abello A/S |
Not applicable |
| Dostarlimab | Antineoplastic agents | 2024-06 | GlaxoSmithKline Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Dupilumab | Other dermatological preparations | 2024-03 | Sanofi-Aventis Canada Inc |
Being reviewed under the Priority Review Policy |
| Dupilumab | Other dermatological preparations | 2024-06 | Sanofi-Aventis Canada Inc |
Not applicable |
| Durvalumab | Antineoplastic agents | 2024-01 | AstraZeneca Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Durvalumab | Antineoplastic agents | 2024-01 | AstraZeneca Canada Inc |
Not applicable |
| Durvalumab | Endocrine therapy | 2024-01 | AstraZeneca Canada Inc |
Not applicable |
| Durvalumab | Antineoplastic agents | 2024-05 | AstraZeneca Canada Inc |
Not applicable |
| Fibrinogen (human), thrombin (human) | Antihemorrhagics | 2024-01 | Instituto Grifols S.A. |
Not applicable |
| Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 2023-11 | Telix Pharmaceuticals (US) Inc |
Not applicable |
| Guselkumab | Immunosuppressants | 2024-06 | Janssen Inc |
Not applicable |
| Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | 2023-08 | Takeda Canada Inc |
Not applicable |
| IncobotulinumtoxinA | Muscle relaxants | 2023-10 | Merz Pharmaceuticals GmbH |
Not applicable |
| Isatuximab | Antineoplastic agents | 2024-06 | Sanofi-Aventis Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Isavuconazonium sulfate | Antimycotics for systemic use | 2023-12 | Avir Pharma Inc |
Not applicable |
| Linaclotide | Drugs for constipation | 2023-11 | Abbvie Corporation |
Not applicable |
| Lisocabtagene maraleucel | Antineoplastic agents | 2023-11 | Celgene Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Luspatercept | Antianemic preparations | 2023-11 | Celgene Inc |
Not applicable |
| Lutetium (177Lu) oxodotreotide | Therapeutic radiopharmaceuticals | 2024-02 | Novartis Pharmaceuticals Canada Inc |
Not applicable |
| Macitentan | Antihypertensives | 2024-02 | Janssen Inc |
Not applicable |
| Nivolumab | Antineoplastic agents | 2024-03 | Bristol-Myers Squibb Canada |
Not applicable |
| Nivolumab | Antineoplastic agents | 2024-08 | Bristol-Myers Squibb Canada |
Not applicable |
| Olaparib | Antineoplastic agents | 2024-05 | AstraZeneca Canada Inc |
Not applicable |
| OnabotulinumtoxinA | Muscle relaxants | 2024-05 | Abbvie Corporation |
Not applicable |
| Osimertinib mesylate | Antineoplastic agents | 2024-08 | AstraZeneca Canda Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Pembrolizumab | Antineoplastic agents | 2023-06 | Merck Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Pembrolizumab | Antineoplastic agents | 2024-04 | Merck Canada Inc |
Not applicable |
| Pembrolizumab | Antineoplastic agents | 2024-05 | Merck Canada Inc |
Not applicable |
| Pembrolizumab | Antineoplastic agents | 2024-06 | Merck Canada Inc |
Not applicable |
| Pitolisant hydrochloride | Other nervous system drugs | 2024-04 | Endo Ventures Ltd |
Not applicable |
| Plecanatide | Drugs for constipation | 2024-01 | Bausch Health, Canada Inc. |
Not applicable |
| Ranolazine | Cardiac therapy | 2022-08 | KYE Pharmaceuticals Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Respiratory syncytial virus prefusion F protein (RSVPreF3) | Vaccines | 2024-01 | GlaxoSmithKline Inc |
Not applicable |
| Ribociclib succinate | Antineoplastic agents | 2024-08 | Novartis Pharmaceuticals Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Risankizumab | Immunosuppressants | 2023-12 | Abbvie Corporation |
Not applicable |
| Risdiplam | Other drugs for disorders of the musculo-skeletal system | 2024-04 | Hoffmann-La Roche Limited |
Being reviewed under the Priority Review Policy |
| Roflumilast | Antipsoriatics | 2023-12 | Arcutis Canada, Inc. |
Not applicable |
| Roflumilast | Antipsoriatics | 2024-05 | Arcutis Canada, Inc. |
Not applicable |
| Sarilumab | Immunosuppressants | 2024-07 | Sanofi-Aventis Canada Inc |
Not applicable |
| Semaglutide | Drugs used in diabetes | 2023-12 | Novo Nordisk Canada Inc |
Not applicable |
| Semaglutide | Drugs used in diabetes | 2024-02 | Novo Nordisk Canada Inc |
Not applicable |
| Semaglutide | Drugs used in diabetes | 2024-05 | Novo Nordisk Canada Inc |
Not applicable |
| Semaglutide | Drugs used in diabetes | 2024-07 | Novo Nordisk Canada Inc |
Not applicable |
| Standardized allergen extract, white birch (Betula verrucosa) | Allergens | 2024-07 | ALK – Abello A/S |
Not applicable |
| Talazoparib | Antineoplastic agents | 2023-05 | Pfizer Canada ULC |
Part of an 'aligned review' with a health technology assessment organization |
| Tenecteplase | Antithrombotic agents | 2024-08 | Hoffmann-la Roche Limited |
Not applicable |
| Trastuzumab deruxtecan | Antineoplastic agents | 2024-05 | AstraZeneca Canada Inc |
Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
| Trastuzumab deruxtecan | Antineoplastic agents | 2024-08 | AstraZeneca Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
| Treosulfan | Antineoplastic agents | 2024-03 | Medexus Pharmaceuticals Inc. |
Not applicable |
| Ustekinumab | Immunosuppressants | 2024-05 | JAMP Pharma Corporation |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
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