Drug and Health Product Submissions Under Review (SUR): New drug submissions under review

This list is current as of: 2024-04-30.

An Excel version of the updated SUR List is available from the Overview page.

Submissions currently under review: New drug submissions
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

Amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine sulfate, mixed salts amphetamine Psychoanaleptics 2024-04 KYE Pharmaceuticals Inc Not applicable
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
Lazertinib mesylate monohydrate Antineoplastic agents 2024-04 Janssen Inc New active substance
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
Naloxone hydrochloride dihydrate All other therapeutic products 2024-04 Hikma Canada Limited Not applicable
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 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
Retifanlimab Antineoplastic agents 2024-04 Incyte 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

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
Trofinetide Other nervous system drugs 2024-04 Acadia Pharmaceuticals Inc

New active substance

Being reviewed under the Priority Review Policy

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

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

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

Footnote **

This applicant has filed a new drug submission under the Food and Drug Regulations, to transition this product from the interim order. The product continues to be approved for sale in Canada during this transition period.

Return to footnote ** referrer

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