Drug and Health Product Submissions Under Review (SUR): New drug submissions under review
This list is current as of: 2025-11-30.
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 Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Afamelanotide |
Emollients and protectives |
2024-12 |
Clinuvel, Inc. |
New active substance |
Aflibercept |
Ophthalmologicals |
2025-07 |
JAMP Pharma Corporation |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Aprocitentan |
Antihypertensives |
2025-01 |
Idorsia Pharmaceuticals Ltd |
New active substance |
Aripiprazole |
Psycholeptics |
2024-09 |
Odan Laboratories Ltd |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Atrasentan hydrochloride |
Agents acting on the renin-angiotensin system |
2025-07 |
Novartis Pharmaceuticals Canada Inc |
New active substance |
Avacincaptad pegol |
Ophthalmologicals |
2025-02 |
Astellas Pharma Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
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 |
Bempedoic acid, ezetimibe |
Lipid modifying agents |
2025-01 |
HLS Therapeutics Inc |
Not applicable |
Betamethasone dipropionate, calcipotriol monohydrate |
Antipsoriatics |
2025-07 |
Glenmark Pharmaceuticals Canada Inc. |
Not applicable |
Benzoyl peroxide, tretinoin |
Anti-acne preparations |
2025-02 |
Searchlight Pharma Inc |
Not applicable |
Bevacizumab |
Antineoplastic agents |
2025-06 |
Curateq Biologics Private Limited |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Bimatoprost |
Ophthalmologicals |
2025-10 |
Laboratoires Thea |
Not applicable |
Camizestrant |
Endocrine therapy |
2025-10 |
AstraZeneca Canada Inc |
New active substance 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 |
Chikungunya virus virus-like particle (CHIKV VLP) |
Vaccines |
2025-07 |
Bavarian Nordic AS |
New active substance |
Chloroprocaine hydrochloride |
Ophthalmologicals |
2025-02 |
Apotex Inc |
Part of 'aligned review' with a health technology assessment organization |
Cilastatin sodium, imipenem, relebactam |
Antibacterials for systemic use |
2025-05 |
Merck Canada Inc |
New active substance Being reviewed under the Priority Review Policy |
Citalopram hydrobromide |
Psychoanaleptics |
2025-08 |
Mint Pharmaceuticals Inc |
Not applicable |
Clesrovimab |
Immune sera and immunoglobulins |
2025-04 |
Merck Canada Inc |
New active substance |
Clobetasol propionate |
Ophthalmologicals |
2025-03 |
Apotex Inc |
Part of 'aligned review' with a health technology assessment organization |
Cyclosporine |
Ophthalmologicals |
2025-01 |
Apotex Inc |
Not applicable |
Cysteamine hydrochloride |
Ophthalmologicals |
2024-05 |
Leadiant Biosciences, Inc. |
Part of 'aligned review' with a health technology assessment organization |
Denosumab |
Drugs for treatment of bone diseases |
2024-05 |
Samsung Bioepis Co., Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-05 |
Samsung Bioepis Co., Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-07 |
Mantra Pharma Inc. |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-09 |
Shanghai Henlius Biotech, Inc. |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-09 |
Shanghai Henlius Biotech, Inc. |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-10 |
Biosimilar Collaborations Ireland Limited |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Denosumab |
Drugs for treatment of bone diseases |
2024-10 |
Biosimilar Collaborations Ireland Limited |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Denosumab |
Drugs for treatment of bone diseases |
2024-11 |
Apotex Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Denosumab |
Drugs for treatment of bone diseases |
2024-11 |
Apotex Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Denosumab |
Drugs for treatment of bone diseases |
2025-06 |
Fresenius Kabi Canada Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2025-06 |
Fresenius Kabi Canada Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2025-09 |
JAMP Pharma Corporation |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Denosumab |
Drugs for treatment of bone diseases |
2025-09 |
JAMP Pharma Corporation |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Depemokimab |
Drugs for obstructive airway diseases |
2025-04 |
GlaxoSmithKline 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 |
Doravirine, islatravir |
Antivirals for systemic use |
2025-08 |
Merck Canada Inc |
New active substance |
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 |
Epinephrine |
Drugs for obstructive airway diseases |
2025-02 |
ARS Pharmaceuticals Operations, Inc. |
Part of 'aligned review' with a health technology assessment organization |
Escitalopram oxalate |
Psychoanaleptics |
2025-09 |
Orimed Pharma Inc |
Not applicable |
Fenfluramine hydrochloride |
Antiepileptics |
2025-11 |
UCB Canada Inc |
Part of 'aligned review' with a health technology assessment organization |
Gabapentin |
Analgesics |
2025-11 |
Rubicon Research Canada Limited |
Not applicable |
Gadopiclenol |
Contrast media |
2025-04 |
Bracco Imaging Canada |
New active substance |
Gadoquatrane |
Contrast media |
2025-09 |
Bayer Inc |
New active substance |
Gepirone hydrochloride |
Psychoanaleptics |
2025-08 |
Xediton Pharmaceuticals Inc |
New active substance |
Glucagon |
Pancreatic hormones |
2024-11 |
Lupin Pharma Canada Limited |
Not applicable |
Golimumab |
Immunosuppressants |
2025-06 |
JAMP Pharma Corporation |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Imlunestrant tosylate |
Antineoplastic agents |
2025-02 |
Eli Lilly Canada Inc |
New active substance Part of an 'aligned review' with a health technology assessment organization |
Latanoprost |
Ophthalmologicals |
2025-01 |
Orimed Pharma Inc |
Not applicable |
Latanoprost, timolol maleate |
Ophthalmologicals |
2025-01 |
Orimed Pharma Inc |
Not applicable |
Lenacapavir sodium |
Antivirals for systemic use |
2025-06 |
Gilead Sciences Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
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 |
Leuprolide mesylate |
Endocrine therapy |
2025-06 |
Accord Healthcare Inc |
Part of an 'aligned review' with a health technology assessment organization |
Levothyroxine sodium |
Thyroid therapy |
2025-07 |
Biosyent Pharma Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
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 |
Methohexital sodium |
Anesthetics |
2024-09 |
Sterimax Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Mosunetuzumab |
Antineoplastic agents |
2025-06 |
Hoffmann-La Roche Limited |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of 'aligned review' with a health technology assessment organization |
Mosunetuzumab |
Antineoplastic agents |
2025-08 |
Hoffmann-La Roche Limited |
Being reviewed under the Notice of Compliance with Conditions Guidance |
Nadofaragene firadenovec |
Antineoplastic agents |
2025-04 |
Ferring Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Nemolizumab |
Other dermatological preparations |
2024-06 |
Galderma Canada Inc. |
New active substance Part of 'aligned review' with a health technology assessment organization |
Nipocalimab |
Immunosuppressants |
2025-01 |
Janssen inc |
New active substance |
Octreotide hydrochloride |
Pituitary and hypothalamic hormones and analogues |
2025-11 |
Camurus AB |
Not applicable |
Olezarsen sodium |
Lipid modifying agents |
2025-06 |
Theratechnologies Inc |
New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
Palopegteriparatide |
Calcium homeostasis |
2025-03 |
Pendopharm Division of Pharmascience Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Pegfilgrastim |
Immunostimulants |
2025-03 |
Curateq Biologics Private Limited |
Biosimilar |
Pegunigalsidase alfa |
Other alimentary tract and metabolism products |
2024-11 |
Chiesi Farmaceutici S.P.A. |
New active substance |
Pegzilarginase |
Other alimentary tract and metabolism products |
2025-10 |
Immedica Pharma AB |
New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
Pertuzumab |
Antineoplastic agents |
2025-05 |
Shanghai Henlius Biotech, Inc. |
Biosimilar |
Plozasiran |
Lipid modifying agents |
2025-07 |
Arrowhead Pharmaceuticals, Inc. |
New active substance Being reviewed under the Priority Review Policy |
Pregabalin |
Analgesics |
2025-01 |
Orimed Pharma Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance Part of 'aligned review' with a health technology assessment organization |
Ranibizumab |
Ophthalmologicals |
2025-08 |
Apotex Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Remibrutinib |
Immunosuppressants |
2025-09 |
Novartis Pharmaceuticals Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Rifapentine |
Antimycobacterials |
2025-03 |
Macleods Pharmaceuticals Limited |
New active substance 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 |
Ropeginterferon alfa-2b |
Immunostimulants |
2025-09 |
Forus Therapeutics Inc |
New active substance |
Sevabertinib |
Antineoplastic agents |
2025-05 |
Bayer Inc |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of 'aligned review' with a health technology assessment organization |
Sotagliflozin |
Drugs used in diabetes |
2025-10 |
BGP Pharma ULC |
New active substance Part of 'aligned review' with a health technology assessment organization |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
2025-01 |
Tolmar International Ltd. |
Not applicable |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
2025-09 |
Verity Pharmaceuticals Inc |
Not applicable |
Tislelizumab |
Antineoplastic agents |
2025-02 |
BeOne Medicines I GmbH |
New active substance Part of 'aligned review' with a health technology assessment organization |
Tislelizumab |
Antineoplastic agents |
2025-06 |
Beigene Switzerland GmbH |
Not applicable |
Tolebrutinib |
Immunosuppressants |
2025-08 |
Sanofi-Aventis Canada Inc |
New active substance |
Tovorafenib |
Antineoplastic agents |
2025-10 |
Ipsen Biopharmaceuticals 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 |
Trastuzumab |
Antineoplastic agents |
2017-11 |
Not available |
Not available |
Trastuzumab |
Antineoplastic agents |
2017-11 |
Not available |
Not available |
Trastuzumab |
Antineoplastic agents |
2018-02 |
Not available |
Not available |
Trastuzumab |
Antineoplastic agents |
2025-09 |
Curateq Biologics Private Limited |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
TrenibotulinumtoxinE |
Muscle relaxants |
2025-09 |
Abbvie Corporation |
New active substance |
Ustekinumab |
Immunosuppressants |
2024-05 |
Accord Healthcare Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Varenicline |
Ophthalmologicals |
2025-11 |
BGP Pharma ULC |
Not applicable |
Viloxazine hydrochloride |
Psychoanaleptics |
2024-12 |
Knight Therapeutics Inc. |
New active substance |
Vosoritide |
Drugs for treatment of bone diseases |
2025-02 |
Biomarin International Limited |
New active substance |
Zanidatamab |
Antineoplastic agents |
2025-04 |
Jazz Pharmaceuticals Ireland Limited |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
Zuranolone |
Psychoanaleptics |
2024-12 |
Biogen Canada Inc |
New active substance |