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 |
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