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

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)
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
Footnote *

This submission is being added to this list at the receipt of submission, and will be reviewed under expedited timelines, due to its relevance to the ongoing COVID-19 pandemic.

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