Drug and Health Product Submissions Under Review (SUR): New drug submissions under review
This list is current as of: 2026-07-31.
An Excel version of the updated SUR List is available from the Overview page.
| 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) |
|---|---|---|---|---|
(18F)PSMA-1007 |
Diagnostic radiopharmaceuticals |
2025-09 |
Centre for Probe Development and Commercialization |
New active substance |
Acoltremon |
Ophthalmologicals |
2026-02 |
Alcon Canada Inc |
New active substance |
Acoramidis hydrochloride |
Cardiac therapy |
2026-05 |
BridgeBio Europe B.V. |
New active substance |
Aficamten |
Cardiac therapy |
2025-12 |
Cytokinetics, Incorporated |
New active substance |
Aflibercept |
Ophthalmologicals |
2025-07 |
JAMP Pharma Corporation |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Anagrelide hydrochloride |
Antineoplastic agents |
2026-01 |
Septa Pharmaceuticals Inc |
Not applicable |
Anitocabtagene autoleucel |
Antineoplastic agents |
2026-07 |
Gilead Sciences 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 |
Asundexian |
Antithrombotic agents |
2026-07 |
Bayer Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Avacincaptad pegol |
Ophthalmologicals |
2025-02 |
Astellas Pharma Canada Inc |
New active substance |
Avibactam sodium, ceftazidime |
Antibacterials for systemic use |
2025-08 |
Sterimax Inc |
New active substance Being reviewed under the Priority Review Policy Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Axatilimab |
Immunosuppressants |
2025-01 |
Incyte Corporation |
New active substance |
Baxdrostat |
Antihypertensives |
2026-06 |
AstraZeneca Canada Inc |
New active substance |
Bempedoic acid, ezetimibe |
Lipid modifying agents |
2025-01 |
HLS Therapeutics Inc |
Not applicable |
Bepirovirsen sodium |
Antivirals for systemic use |
2026-05 |
GlaxoSmithKline Inc |
New active substance |
Betamethasone dipropionate, calcipotriol monohydrate |
Antipsoriatics |
2025-07 |
Glenmark Pharmaceuticals Canada Inc. |
Not applicable |
Bevacizumab |
Antineoplastic agents |
2026-04 |
Sandoz Canada Incorporated |
Biosimilar |
Bimatoprost |
Ophthalmologicals |
2025-10 |
Laboratoires Thea |
Not applicable |
Cagrilintide, semaglutide |
Drugs used in diabetes |
2026-03 |
Novo Nordisk Canada Inc |
New active substance |
Camizestrant |
Endocrine therapy |
2025-10 |
AstraZeneca Canada Inc |
New active substance |
Capsaicin |
Anesthetics |
2026-01 |
Searchlight Pharma Inc |
Part of 'aligned review' with a health technology assessment organization |
Carbidopa, levodopa |
Anti-parkinson drugs |
2025-07 |
Knight Therapeutics Inc. |
Not applicable |
Ceftaroline fosamil |
Antibacterials for systemic use |
2025-07 |
Sterimax Inc. |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Centanafadine hydrochloride |
Psychoanaleptics |
2026-06 |
Otsuka Pharmaceutical Co Ltd |
New active substance |
Cosibelimab |
Antineoplastic agents |
2026-06 |
Sun Pharmaceutical Industries, Inc. |
New active substance |
Cyclosporine |
Ophthalmologicals |
2025-01 |
Apotex Inc |
Not applicable |
Datopotamab deruxtecan |
Antineoplastic agents |
2026-02 |
AstraZeneca Canada Inc |
New active substance |
Denecimig |
Antihemorrhagics |
2025-12 |
Novo Nordisk Canada Inc |
New active substance |
Denosumab |
Drugs for treatment of bone diseases |
2024-07 |
Mantra Pharma Inc. |
Biosimilar |
Deuruxolitinib phosphate |
Immunosuppressants |
2025-12 |
Sun Pharmaceutical Industries, Inc. |
New active substance |
Donidalorsen sodium |
Other hematological agents |
2025-12 |
Theratechnologies Inc |
New active substance |
Estetrol monohydrate |
Sex hormones and modulators of the genital system |
2026-05 |
Searchlight Pharma Inc |
Not applicable |
Fenfluramine hydrochloride |
Antiepileptics |
2025-11 |
UCB Canada Inc |
Part of 'aligned review' with a health technology assessment organization |
Filgrastim (r-metHuG-CSF) |
Immunostimulants |
2026-06 |
Curateq Biologics Private Limited |
Biosimilar |
Finasteride |
Other dermatological preparations |
2026-02 |
Searchlight Pharma Inc |
Not applicable |
Gefurulimab |
Immunosuppressants |
2026-04 |
Alexion Pharma GmbH |
New active substance |
Gepirone hydrochloride |
Psychoanaleptics |
2025-08 |
Xediton Pharmaceuticals Inc |
New active substance |
Givinostat hydrochloride |
Other drugs for disorders of the musculo-skeletal system |
2026-06 |
ITF Therapeutics LLC |
New active substance |
Golimumab |
Immunosuppressants |
2026-05 |
Accord Healthcare Inc |
Biosimilar |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
2026-04 |
Seqirus UK Limited |
Not applicable |
Ianalumab |
Immunosuppressants |
2026-05 |
Novartis Pharmaceuticals Canada Inc |
New active substance |
Icotrokinra |
Immunosuppressants |
2025-12 |
Janssen Inc |
New active substance |
Imlunestrant tosylate |
Antineoplastic agents |
2025-02 |
Eli Lilly Canada Inc |
New active substance |
Insulin efsitora alfa |
Drugs used in diabetes |
2026-01 |
Eli Lilly Canada Inc |
New active substance |
Latanoprost, timolol maleate |
Ophthalmologicals |
2025-01 |
Orimed Pharma Inc |
Not applicable |
Linerixibat |
Bile and liver therapy |
2025-08 |
GlaxoSmithKline Inc |
New active substance |
Metformin hydrochloride |
Drugs used in diabetes |
2025-05 |
Pharmaris Canada Inc |
Not applicable |
Metformin hydrochloride |
Drugs used in diabetes |
2025-11 |
Orimed Pharma Inc |
Not applicable |
Methenamine hippurate |
Antibacterials for systemic use |
2026-04 |
Pharmaris Canada Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Methohexital sodium |
Anesthetics |
2024-09 |
Sterimax Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Mirdametinib |
Antineoplastic agents |
2026-06 |
EMD Serono A Division of EMD Inc Canada |
New active substance |
Methylphenidate hydrochloride |
Psychoanaleptics |
2026-05 |
Lupin Pharma Canada Limited |
Not applicable |
mRNA encoding haemagglutinin of B/Victoria lineage, haemagglutinin of influenza A/H1N1, haemagglutinin of influenza A/H3N2, SARS-CoV-2 spike protein NTD-RBD subdomains |
Vaccines |
2026-01 |
Moderna Biopharma Canada Corporation |
New active substance |
mRNA encoding haemagglutinin of B/Victoria lineage, influenza A/H1N1, influenza A/H3N2 |
Vaccines |
2026-01 |
Moderna Biopharma Canada Corporation |
New active substance |
Nerandomilast |
Immunosuppressants |
2025-12 |
Boehringer Ingelheim (Canada) Ltd Ltee |
New active substance |
Nirogacestat hydrobromide |
Antineoplastic agents |
2026-07 |
EMD Serono a Division of EMD Inc Canada |
New active substance Being reviewed under the Priority Review Policy |
Nitrofurantoin |
Antibacterials for systemic use |
2026-02 |
Pharmaris Canada Inc |
Not applicable |
Nivolumab |
Antineoplastic agents |
2026-03 |
Amgen Canada Inc |
Biosimilar |
Octreotide hydrochloride |
Pituitary and hypothalamic hormones and analogues |
2025-11 |
Camurus AB |
Part of 'aligned review' with a health technology assessment organization |
Omalizumab |
Drugs for obstructive airway diseases |
2026-04 |
Advanz Pharma Canada Inc. |
Biosimilar |
Omeprazole |
Drugs for acid related disorders |
2026-03 |
Xeolas Pharmaceuticals Limited |
Not applicable |
Orforglipron calcium |
Drugs used in diabetes |
2026-01 |
Eli Lilly Canada Inc |
New active substance |
Oveporexton |
Psychoanaleptics |
2026-07 |
Takeda Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Pegloticase |
Antigout preparations |
2026-02 |
Amgen Canada Inc |
New active substance |
Perampanel |
Antiepileptics |
2026-05 |
Sun Pharma Canada Inc |
Not applicable |
Perflutren protein-type A microspheres |
Contrast media |
2026-01 |
GE HealthCare Canada Inc |
Not applicable |
Pertuzumab |
Antineoplastic agents |
2025-05 |
Shanghai Henlius Biotech, Inc. |
Biosimilar |
Pertuzumab |
Antineoplastic agents |
2026-01 |
Biosimilar Collaborations Ireland Limited |
Biosimilar |
Povorcitinib phosphate |
Immunosuppressants |
2026-07 |
Incyte Corporation |
New active substance Part of 'aligned review' with a health technology assessment organization |
Pregabalin |
Analgesics |
2025-01 |
Orimed Pharma Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Ranibizumab |
Ophthalmologicals |
2025-12 |
Lupin Limited |
Biosimilar |
Regadenoson |
Cardiac therapy |
2026-05 |
Isologic Innovative Radiopharmaceuticals Ltd. |
New active substance |
RelabotulinumtoxinA |
Muscle relaxants |
2026-07 |
Ipsen Biopharm Limited |
Not applicable |
Rucaparib camsylate |
Antineoplastic agents |
2026-02 |
Pharmaand GmbH |
New active substance |
Sarecycline |
Antibacterials for systemic use |
2025-12 |
Searchlight Pharma Inc |
New active substance |
Sebetralstat |
Other hematological agents |
2026-04 |
Pendopharm Division of Pharmascience Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Secukinumab |
Immunosuppressants |
2026-07 |
Celltrion Inc |
Biosimilar |
Sibeprenlimab |
Immunosuppressants |
2026-04 |
Otsuka Pharmaceutical Co Ltd |
New active substance |
Sodium benzoate, sodium phenylacetate |
Other alimentary tract and metabolism products |
2026-03 |
Sterimax Inc |
New active substance |
Sotagliflozin |
Drugs used in diabetes |
2025-10 |
BGP Pharma ULC |
New active substance |
Spinosad |
Ectoparasiticides, including scabicides, insecticides and repellents |
2026-01 |
Cipher Pharmaceuticals Inc |
New active substance |
Sutimlimab |
Immunosuppressants |
2026-06 |
Recordati Rare Diseases Canada Inc |
New active substance |
Suzetrigine |
Analgesics |
2026-05 |
Vertex Pharmaceuticals (Canada) Incorporated |
New active substance |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
2025-09 |
Verity Pharmaceuticals Inc |
Not applicable |
Tolebrutinib |
Immunosuppressants |
2025-08 |
Sanofi-Aventis Canada Inc |
New active substance |
Trastuzumab |
Antineoplastic agents |
2018-02 |
Not available |
Not available |
Trastuzumab |
Antineoplastic agents |
2025-09 |
Curateq Biologics Private Limited |
Biosimilar |
Trilaciclib dihydrochloride |
All other therapeutic products |
2026-02 |
Pharmacosmos A/S |
New active substance |
Varenicline |
Ophthalmologicals |
2025-11 |
BGP Pharma ULC |
Not applicable |
Zongertinib |
Antineoplastic agents |
2026-01 |
Boehringer Ingelheim (Canada) Ltd Ltee |
New active substance |
Zongertinib |
Antineoplastic agents |
2026-07 |
Boehringer Ingelheim (Canada) Ltd Ltee |
Being reviewed under the Notice of Compliance with Conditions Guidance |