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) |
|---|---|---|---|---|
| Abemaciclib | Antineoplastic agents | 2023-03 | Eli Lilly Canada Inc | Not applicable |
| Anidulafungin | Antimycotics for systemic use | 2022-07 | Pfizer Canada ULC | Not applicable |
| Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated | Antihemorrhagics | 2022-11 | Novo Nordisk Canada Inc | Not applicable |
| Aripiprazole | Psycholeptics | 2022-09 | Otsuka Pharmaceutical Co Ltd | Not applicable |
| Baricitinib | Immunosuppressants | 2021-09Footnote * | Eli Lilly Canada Inc | For use in relation to COVID-19 |
| Belzutifan | Antineoplastic agents | 2023-01 | Merck Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
| Bisoprolol fumarate | Beta blocking agents | 2021-01 | Sandoz Canada Incorporated | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Brentuximab vedotin | Antineoplastic agents | 2022-12 | Seagen Inc. | Part of an 'aligned review' with a health technology assessment organization |
| Carfilzomib | Antineoplastic agents | 2022-10 | Amgen Canada Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Cemiplimab | Antineoplastic agents | 2022-05 | Sanofi-Aventis Canada Inc | Not applicable |
| Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F | Vaccines | 2023-01 | Pfizer Canada ULC | Being reviewed under the Priority Review Policy |
| Dabrafenib mesylate | Antineoplastic agents | 2023-01 | Novartis Pharmaceuticals Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
| Dapagliflozin propanediol monohydrate | Drugs used in diabetes | 2022-12 | AstraZeneca Canada Inc | Not applicable |
| Davesomeran, elasomeran | Vaccines | 2023-03Footnote * | ModernaTX, Inc. | For use in relation to COVID-19 |
| Dimethyl fumarate | Immunosuppressants | 2022-04 | Biogen Canada Inc | Not applicable |
| Doravirine | Antivirals for systemic use | 2022-07 | Merck Canada Inc | Not applicable |
| Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 2022-09 | Merck Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2022-06 | Sanofi-Aventis Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2022-09 | Sanofi-Aventis Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2022-11 | Sanofi-Aventis Canada Inc | Being reviewed under the Priority Review Policy |
| Empagliflozin | Drugs used in diabetes | 2023-03 | Boehringer Ingelheim (Canada) Ltd Ltee | Not applicable |
| Famtozinameran, tozinameran | Vaccines | 2023-03Footnote * | BioNTech Manufacturing GmbH | For use in relation to COVID-19 |
| Ibrutinib | Antineoplastic agents | 2022-10 | Janssen Inc | Not applicable |
| IncobotulinumtoxinA | Muscle relaxants | 2022-11 | Merz Pharmaceuticals GmbH | Not applicable |
| Ipilimumab | Antineoplastic agents | 2023-02 | Bristol-Myers Squibb Canada | Not applicable |
| Ivacaftor, lumacaftor | Other respiratory system products | 2022-07 | Vertex Pharmaceuticals (Canada) Incorporated | Not applicable |
| Letermovir | Antivirals for systemic use | 2023-03 | Merck Canada Inc | Being reviewed under the Priority Review Policy |
| Leuprolide acetate | Endocrine therapy | 2021-10 | Verity Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Leuprolide acetate | Endocrine therapy | 2022-12 | AbbVie Corporation | Not applicable |
| Leuprolide acetate | Endocrine therapy | 2022-12 | Tolmar International Ltd. | Not applicable |
| Lumasiran sodium | Other alimentary tract and metabolism products | 2022-07 | Alnylam Netherlands B.V. | Not applicable |
| Nivolumab | Antineoplastic agents | 2023-03 | Bristol-Myers Squibb Canada | Not applicable |
| Olaparib | Antineoplastic agents | 2022-08 | AstraZeneca Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Pembrolizumab | Antineoplastic agents | 2022-06 | Merck Canada Inc | Not applicable |
| Pembrolizumab | Antineoplastic agents | 2023-03 | Merck Canada Inc | Not applicable |
| Pimecrolimus | Other dermatological preparations | 2021-01 | Bausch Health, Canada Inc. | Not applicable |
| Pitolisant hydrochloride | Other nervous system drugs | 2023-02 | Endo Ventures Ltd | Not applicable |
| Ranolazine | Cardiac therapy | 2022-08 | KYE Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Ravulizumab | Immunosuppressants | 2023-01 | Alexion Pharma GmbH | Not applicable |
| Remdesivir | Antivirals for systemic use | 2022-07Footnote * | Gilead Sciences Canada Inc | For use in relation to COVID-19 |
| Sacituzumab govitecan | Antineoplastic agents | 2023-01 | Gilead Sciences Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
| SARS-CoV-2 recombinant spike protein | Vaccines | 2023-03Footnote * | Novavax Inc. | For use in relation to COVID-19 |
| Secukinumab | Immunosuppressants | 2022-12 | Novartis Pharmaceuticals Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Semaglutide | Drugs used in diabetes | 2022-09 | Novo Nordisk Canada Inc | Not applicable |
| Tofacitinib citrate | Immunosuppressants | 2022-07 | Pfizer Canada ULC | Not applicable |
| Tofacitinib citrate | Immunosuppressants | 2023-03 | Pfizer Canada ULC | Not applicable |
| Trametinib | Antineoplastic agents | 2023-01 | Novartis Pharmaceuticals Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
| Upadacitinib | Immunosuppressants | 2021-12 | AbbVie Corporation | Part of an 'aligned review' with a health technology assessment organization |
| Upadacitinib | Immunosuppressants | 2022-07 | AbbVie Corporation | Not applicable |
| Upadacitinib | Immunosuppressants | 2022-12 | AbbVie Corporation | Not applicable |
| Zanubrutinib | Antineoplastic agents | 2022-07 | Beigene Switzerland GmbH | Part of an 'aligned review' with a health technology assessment organization |
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