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) |
|---|---|---|---|---|
| Adapalene, benzoyl peroxide, clindamycin phosphate | Anti-acne preparations | 2023-10 | Bausch Health, Canada Inc. | Part of 'aligned review' with a health technology assessment organization |
| Aflibercept | Ophthalmologicals | 2022-05 | Biosimilar Collaborations Ireland Limited | Biosimilar |
| Aflibercept | Ophthalmologicals | 2023-09 | Celltrion HealthCare Co Ltd | Biosimilar |
| Aflibercept | Ophthalmologicals | 2023-10 | Amgen Canada Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Aflibercept | Ophthalmologicals | 2024-02 | Apotex Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
| 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 |
| Avapritinib | Antineoplastic agents | 2023-11 | Blueprint Medicines Corporation | New active substance |
| AZD3152 | Immune sera and immunoglobulins | 2024-03 | AstraZeneca Canada Inc | For use in relation to COVID-19 |
| 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 |
| Cabotegravir, cabotegravir sodium | Antivirals for systemic use | 2023-11 | ViiV Healthcare ULC | Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| 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 |
| Celecoxib | Antiinflammatory and antirheumatic products | 2024-02 | Scilex Pharmaceuticals Inc. | Part of 'aligned review' with a health technology assessment organization |
| Chikungunya virus live-attenuated | Vaccines | 2023-08 | Valneva Austria GmbH | New active substance |
| Chloroprocaine hydrochloride | Anesthetics | 2023-05 | B. Braun Melsungen AG | Not applicable |
| Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotype 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B | Vaccines | 2024-01 | Merck Canada Inc | New active substance Being reviewed under the Priority Review Policy |
| Cyclophosphamide, cyclophosphamide monohydrate | Antineoplastic agents | 2023-08 | Dr Reddys Laboratories Ltd | Not applicable |
| Danicopan | Other hematological agents | 2023-09 | Alexion Pharma GmbH | New active substance |
| Delgocitinb | Other dermatological preparations | 2024-02 | Leo Pharma Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
| Donanemab | Psychoanaleptics | 2024-02 | Eli Lilly Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
| 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 |
| Eplontersen | Other nervous system drugs | 2023-08 | Ionis Pharmaceuticals Inc | New active substance |
| Ethinyl estradiol, segesterone acetate | Sex hormones and modulators of the genital system | 2023-11 | Duchesnay Inc | New active substance |
| Exagamglogene autotemcel | Other hematological agents | 2024-03 | Vertex Pharmaceuticals (Canada) Incorporated |
New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| Ferric maltol | Antianemic preparations | 2022-06 | KYE Pharmaceuticals Inc | New active substance |
| Fezolinetant | Other gynecologicals | 2024-01 | Astellas Pharma Canada 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 |
| Fruquintinib | Antineoplastic agents | 2023-11 | Takeda Canada Inc | New active substance |
| Garadacimab | Antithrombotic agents | 2023-12 | CSL Behring Canada Inc | New active substance |
| Gefapixant | Cough and cold preparations | 2021-12 | Merck Canada Inc | New active substance |
Iptacopan hydrochloride |
Immunosuppressants |
2024-03 |
Novartis Pharmaceuticals Canada Inc |
New active substance |
| Ivosidenib | Antineoplastic agents | 2023-09 | Servier Canada Inc | New active substance |
| Labetalol hydrochloride | Beta blocking agents | 2023-11 | Hikma Canada Limited | Not applicable |
| 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 |
| Leniolisib | Immunostimulants | 2023-10 | Pharming Technologies BV | New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| Lidocaine hydrochloride, nifedipine | Vasoprotectives | 2022-11 | Seaford Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Marstacimab | Antihemorrhagics | 2023-12 | Pfizer Canada ULC | New active substance |
| Meropenem trihydrate, vaborbactam | Antibacterials for systemic use | 2024-01 | Xediton Pharmaceuticals Inc | New active substance Being reviewed under the Priority Review Policy |
| Methylphenidate hydrochloride | Psychoanaleptics | 2024-01 | Ironshore Pharmaceuticals & Development Inc | Not applicable |
| Momelotinib dihydrochloride monohydrate | Antineoplastic agents | 2024-01 | GlaxoSmithKline Inc | New active substance |
| Omalizumab | Drugs for obstructive airway diseases | 2024-02 | Celltrion Healthcare Co Ltd | Biosimilar |
| Osilodrostat phosphate | Corticosteroids for systemic use | 2023-02 | Recordati Rare Diseases Canada Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| 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 |
| Pegfilgrastim | Immunostimulants | 2023-12 | JAMP Pharma Corporation | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Perfluorohexyloctane | Ophthalmologicals | 2023-08 | Bausch & Lomb Inc | New active substance |
| 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 |
| Respiratory syncytial virus (RSV), mRNA | Vaccines | 2024-01 | Moderna Biopharma Canada Corporation | New active substance |
| Risperidone | Psycholeptics | 2022-03 | Teva Canada Limited | Part of 'aligned review' with a health technology assessment organization |
| Rituximab | Antineoplastic agents | 2024-02 | Dr. Reddy's Laboratories SA |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Ropivacaine hydrochloride | Anesthetics | 2023-05 | Formative Pharma Inc. | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Rozanolixizumab | Other drugs for disorders of the musculo-skeletal system | 2023-11 | UCB Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
| Ruxolitinib phosphate | Other dermatological preparations | 2023-03 | Incyte Corporation | Not applicable |
| Sotatercept | Antihypertensives | 2024-03 | Merck Canada Inc | New active substance Being reviewed under the Priority Review Policy |
| 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 |
| Talquetamab | Janssen Inc | 2023-09 | Janssen Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| Tapinarof | Antipsoriatics | 2023-05 | Dermavant Sciences GmbH | New active substance |
| Tarlatamab | Antineoplastic agents | 2024-01 | Amgen Canada Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| Terbinafine hydrochloride | Antifungals for dermatological use | 2024-01 | Medexus Pharmaceuticals Inc. | Not applicable |
| Tocilizumab | Immunosuppressants | 2023-12 | Fresenius Kabi Canada Ltd | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Tofersen | Other nervous system drugs | 2024-03 | Biogen Canada Inc | 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 |
| Triamcinolone acetonide | Corticosteroids, dermatological preparations | 2024-03 | Bausch & Lomb Inc | Not applicable |
| Ustekinumab | Immunosuppressants | 2023-08 | Celltrion Healthcare Co Ltd | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Ustekinumab (2 submissions under review) |
Immunosuppressants | 2023-10 | Samsung Bioepis Co,. Ltd. | Biosimilar |
| Ustekinumab | Immunosuppressants | 2024-03 | Fresenius Kabi Canada Ltd | Biosimilar Part of ‘aligned review’ with a health technology assessment organization |
| Vorasidenib citrate | Antineoplastic agents | 2024-03 | Servier Canada Inc | New active substance Being reviewed under the Priority Review Policy |
| Whole virion inactivated coronavirus | Vaccines | 2021-07Footnote * | Vaccigen Ltd | For use in relation to COVID-19 New active substance |
| Zilucoplan | Immunosuppressants | 2023-08 | UCB Canada Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| Zolbetuximab | Antineoplastic agents | 2024-02 | Astellas Pharma Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
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