Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review
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) |
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Aflibercept | Ophthalmologicals | 2023-09 | Bayer Inc | Not applicable |
Alectinib hydrochloride | Antineoplastic agents | 2024-01 | Hoffmann-La Roche Limited | Being reviewed under the Priority Review Policy |
Amivantamab | Antineoplastic agents | 2024-01 | Janssen Inc | Being reviewed under the Priority Review Policy |
Aripiprazole | Psycholeptics | 2022-09 | Otsuka Pharmaceutical Co Ltd | Part of an 'aligned review' with a health technology assessment organization |
Atenolol | Beta blocking agents | 2023-09 | Pharmascience Inc | Not applicable |
Atenolol | Beta blocking agents | 2023-09 | Teva Canada Limited | Not applicable |
Atenolol | Beta blocking agents | 2023-10 | Apotex Inc | Not applicable |
Atogepant | Analgesics | 2023-07 | Abbvie Corporation | Not applicable |
Belimumab | Immunosuppressants | 2023-11 | GlaxoSmithKline Inc | Not applicable |
Belzutifan | Antineoplastic agents | 2024-02 | Merck Canada Inc | Not applicable |
Bimekizumab | Immunosuppressants | 2023-05 | 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 |
Ciltacabtagene autoleucel | Antineoplastic agents | 2023-08 | Janssen Inc | Not applicable |
Dalbavancin | Antibacterials for systemic use | 2023-09 | Endo Ventures Ltd | 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 |
Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 2024-01 | Vertex Pharmaceuticals (Canada) Incorporated | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Enfortumab vedotin | Antineoplastic agents | 2024-02 | Seagen Inc. |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Faricimab | Ophthalmologicals | 2023-09 | Hoffmann-La Roche Limited | 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 |
Goserelin acetate | Endocrine therapy | 2023-07 | Tersera Therapeutics LLC | Not applicable |
Hexaminolevulinate hydrochloride | Diagnostic agents | 2023-05 | Photocure ASA | Not applicable |
Hyaluronidase (human recombinant), immunoglobulin (human) (2 submissions under review) |
Immune sera and immunoglobulins | 2023-08 | Takeda Canada Inc | Not applicable |
IncobotulinumtoxinA | Muscle relaxants | 2023-10 | Merz Pharmaceuticals GmbH | Not applicable |
Isavuconazonium sulfate | Antimycotics for systemic use | 2023-12 | Avir Pharma Inc | Not applicable |
Leuprolide acetate | Endocrine therapy | 2021-10 | Verity Pharmaceuticals Inc | Not applicable |
Linaclotide | Drugs for constipation | 2023-11 | Abbvie Corporation | Not applicable |
Lisocabtagene maraleucel | Antineoplastic agents | 2023-11 | Celgene Inc | Not applicable |
Luspatercept | Antianemic preparations | 2023-11 | Celgene Inc | Not applicable |
Lutetium (177Lu) oxodotreotide | Therapeutic radiopharmaceuticals | 2024-02 | Advanced Accelerator Applications USA, Inc. | Not applicable |
Macitentan | Antihypertensives | 2024-02 | Janssen Inc | Not applicable |
Nivolumab | Antineoplastic agents | 2024-01 | Bristol-Myers Squibb Canada | Being reviewed under the Priority Review Policy |
OnabotulinumtoxinA | Muscle relaxants | 2023-06 | Abbvie Corporation | Not applicable |
Osimertinib mesylate | Antineoplastic agents | 2023-10 | AstraZeneca Canada Inc | Being reviewed under the Priority Review Policy |
Palbociclib | Antineoplastic agents | 2023-05 | Pfizer Canada ULC | Not applicable |
Pembrolizumab | Antineoplastic agents | 2023-05 | Merck Canada Inc | Not applicable |
Pembrolizumab | Antineoplastic agents | 2023-06 | Merck Canada Inc | Not applicable |
Pembrolizumab | Antineoplastic agents | 2023-06 | Merck Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
Pembrolizumab | Antineoplastic agents | 2023-08 | Merck Canada Inc | Not applicable |
Pembrolizumab | Antineoplastic agents | 2023-10 | Merck Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
Pembrolizumab | Antineoplastic agents | 2024-02 | Merck Canada Inc | Being reviewed under the Priority Review Policy |
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 |
Risankizumab | Immunosuppressants | 2023-12 | Abbvie Corporation | Not applicable |
Roflumilast | Antipsoriatics | 2023-12 | Arcutis Canada, Inc. | Not applicable |
Secukinumab | Immunosuppressants | 2022-12 | Novartis Pharmaceuticals Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
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 |
Spesolimab | Immunosuppressants | 2023-10 | Boehringer Ingelheim (Canada) Ltd Ltee | Not applicable |
Talazoparib | Antineoplastic agents | 2023-05 | Pfizer Canada ULC | Part of an 'aligned review' with a health technology assessment organization |
Tofacitinib citrate | Immunosuppressants | 2023-03 | Pfizer Canada ULC | Not applicable |
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