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) |
|---|---|---|---|---|
| Acetaminophen, ibuprofen sodium dihydrate | Analgesics | 2022-06 | Biosyent Pharma Inc | Not applicable |
| Aflibercept | Ophthalmologicals | 2022-05 | BGP Pharma ULC | Biosimilar |
| Andusomeran | Vaccines | 2023-06Footnote * | Moderna Biopharma Canada Corporation | For use in relation to COVID-19 |
| Ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate | Drugs for constipation | 2023-07 | Bausch Health, Canada Inc. | Not applicable |
| Atropine sulfate | Ophthalmologicals | 2023-04 | Pharma Stullin Inc. | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Avatrombopag maleate | Antihemorrhagics | 2021-06 | Swedish Orphan Biovitrum AB (publ) | New active substance Part of 'aligned review' with a health technology assessment organization |
| Beclomethasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | 2023-05 | Chiesi Farmaceutici S.P.A. | Part of 'aligned review' with a health technology assessment organization |
| Bortezomib | Antineoplastic agents | 2023-07 | Dr Reddys Laboratories Ltd | Not applicable |
| 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 |
| Capivasertib | Antineoplastic agents | 2023-06 | AstraZeneca Canada Inc | New active substance |
| 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 |
| Denosumab (2 submissions under review) |
Drugs for treatment of bone diseases | 2023-03 | Sandoz Canada Incorporated | Biosimilar |
| Dexamethasone, levofloxacin | Ophthalmologicals | 2021-12 | Xedition Pharmaceuticals Inc | Not applicable |
| Eculizumab | Immunosuppressants | 2022-07 | Amgen Canada Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Eculizumab | Immunosuppressants | 2023-05 | Amgen Canada Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Eculizumab | Immunosuppressants | 2023-07 | Samsung Bioepis Co., Ltd | Biosimilar |
| Efgartigimod alfa | Immunosuppressants | 2022-11 | Argenx BV | New active substance |
| Elranatamab | Antineoplastic agents | 2023-04 | Pfizer Canada ULC | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| Epcoritamab | Antineoplastic agents | 2023-02 | Abbvie Corporation | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| 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 |
| Etranacogene dezaparvovec | Other hematological agents | 2023-04 | CSL Behring Canada Inc | New active substance Being reviewed under the Priority Review Policy |
| Etrasimod L-arginine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2023-03 | Pfizer Canada ULC | New active substance |
| Evinacumab | Lipid modifying agents | 2023-03 | Ultragenyx Pharmaceutical Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| Ferric carboxymaltose | Antianemic preparations | 2023-04 | Vifor (International) Inc | New active substance |
| Ferric maltol | Antianemic preparations | 2022-06 | KYE Pharmaceuticals Inc | New active substance |
| Fidanacogene elaparvovec | Antihemorrhagics | 2023-06 | Pfizer Canada ULC |
New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 2023-01 | Curateq Biologics Private Limited | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Gefapixant | Cough and cold preparations | 2021-12 | Merck Canada Inc | New active substance |
| Inebilizumab | Immunosuppressants | 2023-02 | Horizon Therapeutics Ireland DAC | New active substance |
| Influenza virus type A (H1N1) | Vaccines | 2022-10 | Sanofi Pasteur Limited | Not applicable |
| Insulin icodec | Drugs used in diabetes | 2023-05 | Novo Nordisk Canada Inc | New active substance |
| Landiolol hydrochloride | Beta blocking agents | 2022-02 | Trimedic Therapeutics Inc. | New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Lebrikizumab | Immunosuppressants | 2023-05 | Eli Lilly Canada Inc | New active substance Part of an 'aligned review' with a health technology assessment organization |
| Lecanemab | Psychoanaleptics | 2023-05 | Eisai Limited | New active substance |
| Lidocaine hydrochloride, nifedipine | Vasoprotectives | 2022-11 | Seaford Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| 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 |
| Meropenem trihydrate | Antibacterials for systemic use | 2023-03 | B. Braun Medical Inc | Not applicable |
| 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 |
| Metreleptin | Other alimentary tract and metabolism products | 2023-04 | Amryt Pharmaceuticals DAC | New active substance Being reviewed under the Priority Review Policy |
| Nivolumab, relatlimab | Antineoplastic agents | 2022-09 | Bristol-Myers Squibb Canada | New active substance |
| Odevixibat | Bile and liver therapy | 2023-05 | Medison Pharma Canada Inc. | New active substance Being reviewed under the Priority Review Policy |
| Olipudase alfa | Other alimentary tract and metabolism products | 2023-06 | Sanofi-Aventis Canada Inc |
New active substance Being reviewed under the Priority Review Policy |
| Osilodrostat phosphate | Corticosteroids for systemic use | 2023-02 | Recordati Rare Diseases Canada Inc | New active substance |
| Pegcetacoplan | Immunosuppressants | 2023-03 | Apellis Pharmaceuticals, Inc | Not applicable |
| Pegfilgrastim | Immunostimulants | 2022-05 | Lupin Pharma Canada Limited | Biosimilar |
| Pegfilgrastim | Immunostimulants | 2022-05 | Nora Pharma Inc | Biosimilar |
| Pegfilgrastim | Immunostimulants | 2023-06 | Curateq Biologics Private Limited | Biosimilar |
| Ranibizumab | Ophthalmologicals | 2022-12 | Teva Canada Limited | Biosimilar |
| Raxtozinameran | Vaccines | 2023-06Footnote * | BioNTech Manufacturing GmbH | For use in relation to COVID-19 |
| 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 |
| RelabotulinumtoxinA | Muscle relaxants | 2023-03 | Galderma SA | Not applicable |
| 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 |
| Ropivacaine hydrochloride | Anesthetics | 2023-05 | Formative Pharma Inc. | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| RSV F antigen 847A, recombinant, RSV F antigen 847B, recombinant | Vaccines | 2023-03 | Pfizer Canada ULC | Not applicable |
| Ruxolitinib phosphate | Other dermatological preparations | 2023-03 | Incyte Corporation | 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 |
| Smallpox vaccine dried | Vaccines | 2023-02 | Emergent Product Development Gaithersburg Inc. | Extraordinary use submission |
| 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 |
| Tapinarof | Antipsoriatics | 2023-05 | Dermavant Sciences GmbH | New active substance |
| Trastuzumab | Antineoplastic agents | 2018-02 | Not available | Not available |
| Trastuzumab (2 submissions under review) |
Antineoplastic agents | 2017-11 | Not available | Not available |
| Trastuzumab | Antineoplastic agents | 2023-07 | Accord Healthcare Inc | Biosimilar |
| Tremelimumab | Antineoplastic agents | 2022-05 | AstraZeneca Canada Inc | New active substance |
| Ustekinumab | Immunosuppressants | 2023-01 | Jamp Pharma Corporation | Biosimilar |
| Ustekinumab | Immunosuppressants | 2023-03 | Amgen Canada Inc | Biosimilar Part of ‘aligned review’ with a health technology assessment organization |
| 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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