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)
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
Bimekizumab
(2 submissions under review)
Immunosuppressants 2023-05 UCB 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
Coagulation factor VIII (human), human plasma proteins, von Willebrand factor (human) Antihemorrhagics 2023-05 Octapharma Pharmazeutika Produktionsges M B H 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

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
Infliximab Immunosuppressants 2023-04 Celltrion Healthcare Co Ltd Biosimilar
Isavuconazonium sulfate Antimycotics for systemic use 2023-12 Avir Pharma Inc Not applicable
Leuprolide acetate Endocrine therapy 2021-10 Verity Pharmaceuticals Inc Not applicable
Levonorgestrel Other gynecologicals 2023-04 Bayer 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
Mavacamten Cardiac therapy 2023-04 Bristol-Myers Squibb Canada Not applicable
Nivolumab Antineoplastic agents 2024-01 Bristol-Myers Squibb Canada Being reviewed under the Priority Review Policy
OnabotulinumtoxinA Muscle relaxants 2023-04 Abbvie Corporation Not applicable
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

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

Palbociclib Antineoplastic agents 2023-05 Pfizer Canada ULC Not applicable
Pembrolizumab Antineoplastic agents 2023-03 Merck Canada Inc 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
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
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
Zanubrutinib Antineoplastic agents 2023-04 Beigene Switzerland GmbH 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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