Drug and Health Product Submissions Under Review (SUR): New drug 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) |
---|---|---|---|---|
Abiraterone acetate, niraparib | Endocrine therapy | 2022-08 | Janssen Inc | Not applicable |
Acetaminophen, ibuprofen sodium dihydrate | Analgesics | 2022-06 | Biosyent Pharma Inc | Not applicable |
Aflibercept | Ophthalmologicals | 2022-05 | BGP Pharma ULC | Biosimilar |
Andexanet alfa | All other therapeutic products | 2022-10 | AstraZeneca Canada Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of 'aligned review' with a health technology assessment organization |
Avatrombopag maleate | Antihemorrhagics | 2021-06 | Swedish Orphan Biovitrum AB (publ) | New active substance Part of 'aligned review' with a health technology assessment organization |
BamlanivimabFootnote ** | Immune sera and immunoglobulins | 2021-06Footnote * | Eli Lilly Canada Inc | For use in relation to COVID-19 New active substance Part of 'aligned review' with a health technology assessment organization |
Brincidofovir | Antivirals for systemic use | 2022-05 | Chimerix Inc | Extraordinary use submission |
Calaspargase pegol | Antineoplastic agents | 2022-11 | Servier Canada Inc | New active substance |
Cannabidiol | Antiepileptics | 2023-01 | GW Research Limited | Not applicable |
Captopril | Agents acting on the renin-angiotensin system | 2021-04 | Ethypharm Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Casirivimab, imdevimabFootnote ** | Immune sera and immunoglobulins | 2021-09Footnote * | Hoffmann-La Roche Limited | For use in relation to COVID-19 New active substance Part of 'aligned review' with a health technology assessment organization |
Cefditoren pivoxil | Antibacterials for systemic use | 2022-07 | Orimed Pharma Inc | New active substance |
Cenobamate | Antiepileptics | 2022-07 | Endo Ventures Ltd | New active substance Part of 'aligned review' with a health technology assessment organization |
Clascoterone | Anti-acne preparations | 2022-08 | Sun Pharmaceutical Industries Limited | New active substance Part of 'aligned review' with a health technology assessment organization |
Concizumab | Antihemorrhagics | 2022-09 | Novo Nordisk Canada Inc | New active substance Being reviewed under the Priority Review Policy |
Concizumab | Antihemorrhagics | 2022-09 | Novo Nordisk Canada Inc | Not applicable |
Copper, manganese sulfate, selenious acid, sodium iodide, zinc sulfate | Blood substitutes and perfusion solutions | 2021-03 | Sandoz Canada Incorporated | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Daprodustat | Antianemic preparations | 2022-05 | GlaxoSmithKline Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
Daridorexant hydrochloride | Other nervous system drugs | 2021-10 | Idorsia Pharmaceuticals Ltd | New active substance |
Dexamethasone, levofloxacin | Ophthalmologicals | 2021-12 | Xedition Pharmaceuticals Inc | Not applicable |
Dronabinol | Antiemetics and antinauseants | 2021-05 | Tetra Bio-Pharma Inc. | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Eculizumab | Immunosuppressants | 2022-07 | Amgen Canada Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
Efgartigimod alfa | Immunosuppressants | 2022-11 | Argenx BV | New active substance |
Enoxaparin sodium | Antithrombotic agents | 2022-09 | Baxter Corporation | Biosimilar Part of 'aligned review' with a health technology assessment organization |
Enterococcus faecalis inactivated, Escherichia coli inactivated, Klebsiella pneumoniae inactivated, Proteus vulgaris inactivated | Vaccines | 2022-05 | Red Leaf Medical Inc | New active substance |
Epcoritamab | Antineoplastic agents | 2023-02 | Abbvie Corporation | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
Erwinia L-asparaginase | Antineoplastic agents | 2021-09 | Porton Biopharma Limited | Being reviewed under the Priority Review Policy |
Estradiol, norethindrone acetate, relugolix | Pituitary, hypothalamic hormones and analogues | 2022-11 | Myovant Sciences GmbH | New active substance |
Estradiol, norethindrone acetate, relugolix | Pituitary, hypothalamic hormones and analogues | 2022-12 | Myovant Sciences GmbH | Not applicable |
Etesevimab | Immune sera and immunoglobulins | 2021-09Footnote * | Eli Lilly Canada Inc | New active substance For use in relation to COVID-19 Part of 'aligned review' with a health technology assessment organization |
Ferric maltol | Antianemic preparations | 2022-06 | KYE Pharmaceuticals Inc | New active substance |
Filgrastim (r-metHuG-CSF) | Immunostimulants | 2023-01 | Curateq Biologics Private Limited | Biosimilar Part of 'aligned review' with a health technology assessment organization |
Foscarbidopa, foslevodopa | Anti-parkinson drugs | 2022-07 | AbbVie Corporation | Not applicable |
Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 2022-06 | Advanced Accelerator Applications USA, Inc. | New active substance Part of 'aligned review' with a health technology assessment organization Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Gefapixant | Cough and cold preparations | 2021-12 | Merck Canada Inc | New active substance |
Glofitamab | Antineoplastic agents | 2022-07 | Hoffmann-La Roche Limited | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
Inebilizumab | Immunosuppressants | 2023-02 | Horizon Therapeutics Ireland DAC | New active substance |
Influenza virus type A (H1N1) | Vaccines | 2022-10 | Sanofi Pasteur Limited | Not applicable |
Isotretinoin | Anti-acne preparations | 2022-08 | Sun Pharmaceutical Industries Limited | Part of 'aligned review' with a health technology assessment organization |
JZP-258 | Other nervous system drugs | 2022-07 | Jazz Pharmaceuticals Ireland Limited | Not applicable |
Landiolol hydrochloride | Beta blocking agents | 2022-02 | Trimedic Therapeutics Inc. | New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Lidocaine hydrochloride, nifedipine | Vasoprotectives | 2022-11 | Seaford Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Maralixibat chloride | Bile and liver therapy | 2023-01 | Mirum Pharmaceuticals, Inc. | New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Masitinib mesylate | Antineoplastic agents | 2022-05 | AB Science S.A. | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
Methotrexate | Immunosuppressants | 2022-05 | Nordic Group B.V. | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Methylphenidate hydrochloride | Psychoanaleptics | 2021-01 | KYE Pharmaceuticals Inc | Not applicable |
Mirikizumab | Immunosuppressants | 2022-09 | Eli Lilly Canada Inc | New active substance Part of an 'aligned review' with a health technology assessment organization |
Molnupiravir | Antivirals for systemic use | 2021-08Footnote * | Merck Canada Inc | For use in relation to COVID-19 New active substance |
Nirsevimab | Immune sera and immunoglobulins | 2022-12 | AstraZeneca Canada Inc | New active substance Part of an 'aligned review' with a health technology assessment organization |
Nivolumab, relatlimab | Antineoplastic agents | 2022-09 | Bristol-Myers Squibb Canada | New active substance |
Osilodrostat phosphate | Corticosteroids for systemic use | 2023-02 | Recordati Rare Diseases Canada Inc | New active substance |
Pegfilgrastim | Immunostimulants | 2022-05 | Lupin Pharma Canada Limited | Biosimilar |
Pegfilgrastim | Immunostimulants | 2022-05 | Nora Pharma Inc | Biosimilar |
Ranibizumab | Ophthalmologicals | 2022-12 | Teva Canada Limited | Biosimilar |
Regdanvimab | Immune sera and immunoglobulins | 2021-05Footnote * | Celltrion HealthCare Co Ltd | For use in relation to COVID-19 New active substance Part of 'aligned review' with a health technology assessment organization |
Relugolix | Endocrine therapy | 2022-12 | Myovant Sciences GmbH | New active substance |
Respiratory syncytial virus prefusion F protein (RSVPreF3) | Vaccines | 2022-11 | GlaxoSmithKline Inc | New active substance |
Rimegepant | Analgesics | 2023-01 | Pfizer Canada ULC | New active substance |
Risperidone | Psycholeptics | 2022-03 | Teva Canada Limited | Part of 'aligned review' with a health technology assessment organization |
Risperidone | Psycholeptics | 2022-12 | Laboratorios Farmaceuticos Rovi, S.A. | Not applicable |
Ritlecitinib | Other dermatological preparations | 2023-02 | Pfizer Canada ULC | New active substance |
Roflumilast | Other dermatological preparations | 2022-07 | Arcutis Biotherapeutics, Inc | Not applicable |
Sabizabulin | Antivirals for systemic use | 2022-11Footnote * | Veru Inc. | New active substance For use in relation to COVID-19 Part of 'aligned review' with a health technology assessment organization |
SARS-CoV-2 prefusion spike delta TM protein, recombinant | Vaccines | 2021-07Footnote * | Sanofi Pasteur Limited | For use in relation to COVID-19 New active substance |
SARS-CoV-2 prefusion spike delta TM protein, recombinant | Vaccines | 2022-12Footnote * | Sanofi Pasteur Limited | For use in relation to COVID-19 New active substance |
Setmelanotide acetate | Antiobesity preparations, excluding diet products | 2022-11 | Rhythm Pharmaceuticals, Inc | New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
Smallpox vaccine dried | Vaccines | 2023-02 | Emergent Product Development Gaithersburg Inc. | Extraordinary use submission |
Somapacitan | Pituitary, hypothalamic hormones and analogues | 2022-09 | Novo Nordisk Canada Inc | New active substance |
SotrovimabFootnote ** | Immune sera and immunoglobulins | 2021-10Footnote * | GlaxoSmithKline Inc | For use in relation to COVID-19 New active substance Part of 'aligned review' with a health technology assessment organization |
Spesolimab | Immunosuppressants | 2022-09 | Boehringer Ingelheim (Canada) Ltd Ltee | New active substance Being reviewed under the Priority Review Policy |
Teclistamab | Antineoplastic agents | 2022-12 | Janssen Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
Tirbanibulin | Antibiotics and chemotherapy for dermatological use | 2022-07 | Avir Pharma Inc | New active substance |
Trastuzumab | Antineoplastic agents | 2018-02 | Not available | Not available |
Trastuzumab | Antineoplastic agents | 2021-08 | Prestige BioPharma Ltd. | Biosimilar |
Trastuzumab (2 submissions under review) |
Antineoplastic agents | 2017-11 | Not available | Not available |
Tremelimumab | Antineoplastic agents | 2022-05 | AstraZeneca Canada Inc | New active substance |
Ustekinumab | Immunosuppressants | 2023-01 | Jamp Pharma Corporation | Biosimilar |
Vericiguat | Cardiac therapy | 2021-01 | Bayer Inc | New active substance |
Viable CVD 103-HgR | Vaccines | 2022-07 | Emergent Travel Health Inc. | Not applicable |
Vutrisiran | Other nervous system drugs | 2022-12 | Alnylam Netherlands B.V. | New active substance |
Whole virion inactivated coronavirus | Vaccines | 2021-07Footnote * | Vaccigen Ltd | For use in relation to COVID-19 New active substance |
|
Report a problem or mistake on this page
- Date modified: