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)
Adalimumab Immunosuppressants 2021-10 Amgen Canada Inc

Biosimilar

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

Adalimumab Immunsuppressants 2021-11 BGP Pharma ULC Biosimilar
Adalimumab Immunsuppressants 2021-12 Sandoz Canada Incorporated Biosimilar
Adalimumab Immunsuppressants 2022-02 Pfizer Canada ULC Biosimilar
Anidulafungin Antimycotics for systemic use 2022-07 Pfizer Canada ULC Not applicable
Axicabtagene ciloleucel Antineoplastic agents 2021-10 Gilead Sciences Canada Inc Part of an 'aligned review' with a health technology assessment organization
Axicabtagene ciloleucel Antineoplastic agents 2022-02 Gilead Sciences Canada Inc Part of an 'aligned review' with a health technology assessment organization
Baricitinib Immunosuppressants 2021-09Footnote * Eli Lilly Canada Inc For use in relation to COVID-19
Bevacizumab Antineoplastic agents 2021-12 Apotex Inc Biosimilar
Bevacizumab Antineoplastic agents 2022-02 BGP Pharma ULC Biosimilar
Bisoprolol fumarate Beta blocking agents 2021-01 Sandoz Canada Incorporated Being reviewed under the Submissions Relying on Third-Party Data Guidance
Brexucabtagene autoleucel Antineoplastic agents 2022-04 Gilead Sciences Canada Inc

Being reviewed under the Priority Review Policy

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

Brolucizumab Ophthalmologicals 2022-02 Novartis Pharmaceuticals Canada Inc Part of an 'aligned review' with a health technology assessment organization
Cabotegravir, rilpivirine Antivirals for systemic use 2022-02 ViiV Healthcare ULC Not applicable
Cemiplimab Antineoplastic agents 2022-05 Sanofi-Aventis Canada Inc Not applicable
Cilgavimab, tixagevimab Immune sera and immunoglobulins 2022-06Footnote * AstraZeneca Canada Inc For use in relation to COVID-19
Coagulation factor IX (recombinant), pegylated Antihemorrhagics 2021-12 Novo Nordisk Canada Inc Not applicable
Daratumumab Antineoplastic agents 2022-02 Janssen Inc Not applicable
Darolutamide Endocrine therapy 2022-04 Bayer Inc Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization
Deferiprone All other therapeutic products 2022-06 Chiesi Canada Corp. Not applicable
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 2020-09 ALK - Abello A/S Not applicable
Dimethyl fumarate Immunosuppressants 2022-04 Biogen Canada Inc Not applicable
Doravirine Antivirals for systemic use 2022-07 Merck Canada Inc Not applicable
Dupilumab Other dermatological preparations 2022-06 Sanofi-Aventis Canada Inc Not applicable
Durvalumab Antineoplastic agents 2022-04 AstraZeneca Canada Inc Being reviewed under the Priority Review Policy
Elasomeran Vaccines 2022-04Footnote * ModernaTX, Inc.

For use in relation to COVID-19

Being reviewed under the Submissions Relying on Third-Party Data Guidance

Fosfomycin sodium Antibacterials for systemic use 2021-12 Verity Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Glycerol phenylbutyrate Other alimentary tract and metabolism products 2022-02 Horizon Therapeutics Ireland DAC Not applicable
Ibrutinib Antineoplastic agents 2022-05 Janssen Inc Not applicable
IncobotulinumtoxinA Muscle relaxants 2021-11 Merz Pharmaceuticals GmbH Not applicable
Infliximab Immunosuppressants 2022-04 Celltrion Healthcare Co Ltd Biosimilar
Ivacaftor, lumacaftor Other respiratory system products 2022-07 Vertex Pharmaceuticals (Canada) Incorporated Not applicable
Leuprolide acetate Endocrine therapy 2021-10 Verity Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Lumasiran sodium Other alimentary tract and metabolism products 2022-07 Alnylam Netherlands B.V. Not applicable
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2021-09 Tillotts Pharma AG Not applicable
Methyl aminolevulinate hydrochloride Antineoplastic agents 2022-04 Galderma Canada Inc Not applicable
Migalastat hydrochloride Other alimentary tract and metabolism products 2022-05 Amicus Therapeutics UK Ltd Not applicable
Nivolumab Antineoplastic agents 2022-03 Bristol-Myers Squibb Canada Being reviewed under the Priority Review Policy
Pembrolizumab Antineoplastic agents 2021-10 Merck Canada Inc Not applicable
Pembrolizumab Antineoplastic agents 2021-12 Merck Canada Inc Not applicable
Pembrolizumab Antineoplastic agents 2022-06 Merck Canada Inc Not applicable
Pimecrolimus Other dermatological preparations 2021-01 Bausch Health, Canada Inc. Not applicable
Polatuzumab vedotin Antineoplastic agents 2022-01 Hoffmann-La Roche Limited Not applicable
Ravulizumab Immunosuppressants 2022-01 Alexion Pharma GmbH Part of an 'aligned review' with a health technology assessment organization
Ravulizumab Immunosuppressants 2022-03 Alexion Pharma GmbH Not applicable
Remdesivir Antivirals for systemic use 2022-07Footnote * Gilead Sciences Canada Inc For use in relation to COVID-19
Ribociclib succinate Antineoplastic agents 2022-04 Novartis Pharmaceuticals Canada Inc Not applicable
Risankizumab Immunosuppressants 2021-12 Abbvie Corporation Not applicable
Romosozumab Drugs for treatment of bone diseases 2022-05 Amgen Canada Inc Not applicable
SARS-CoV-2 recombinant spike protein Vaccines 2022-06Footnote * Novavax Inc. For use in relation to COVID-19
Secukinumab Immunosuppressants 2021-11 Novartis Pharmaceuticals Canada Inc Not applicable
Tisagenlecleucel Antineoplastic agents 2022-05 Novartis Pharmaceuticals Canada Inc

Being reviewed under the Priority Review Policy

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

Tocilizumab Immunosuppressants 2022-02Footnote * Hoffmann-La Roche Limited For use in relation to COVID-19
Tofacitinib citrate Immunosuppressants 2022-07 Pfizer Canada ULC Not applicable
Tozinameran Vaccines 2022-05Footnote * Pfizer Canada ULC/BioNTech SE For use in relation to COVID-19
Tozinameran Vaccines 2022-06Footnote * BioNTech Manufacturing GmbH For use in relation to COVID-19
Tralokinumab Other dermatological preparations 2022-04 Leo Pharma Inc Part of an 'aligned review' with a health technology assessment organization
Trastuzumab deruxtecan Antineoplastic agents 2022-07 AstraZeneca Canada Inc Being reviewed under the Priority Review Policy
Upadacitinib Immunosuppressants 2021-12 AbbVie Corporation Not applicable
Upadacitinib Immunosuppressants 2022-07 AbbVie Corporation Not applicable
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.

Return to footnote * referrer

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