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Drug and Health Product Submissions Under Review (SUR): Supplemental 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.

Submissions currently under review: Supplemental new drug submissions for new uses
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)

Acalabrutinib maleate

Antineoplastic agents

2025-12

AstraZeneca Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Adalimumab

Immunosuppressants

2024-09

JAMP Pharma Corporation

Biosimilar

Aflibercept

Ophthalmologicals

2025-12

Bayer Inc

Part of an 'aligned review' with a health technology assessment organization

Alirocumab

Lipid modifying agents

2024-12

Sanofi-Aventis Canada Inc

Not applicable

Atezolizumab

Antineoplastic agents

2026-06

Hoffmann-la Roche Limited

Being reviewed under the Priority Review Policy

Baricitinib

Immunosuppressants

2026-03

Eli Lilly Canada Inc

Not applicable

Belzutifan

Antineoplastic agents

2025-12

Merck Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Belzutifan

Antineoplastic agents

2026-03

Merck Canada Inc

Not applicable

Benralizumab

Drugs for obstructive airway diseases

2025-10

AstraZeneca Canada Inc

Not applicable

Berotralstat hydrochloride

Other hematological agents

2026-03

Biocryst Pharmaceuticals Inc

Part of an 'aligned review' with a health technology assessment organization

Brexpiprazole

Psycholeptics

2026-03

Otsuka Pharmaceutical Co Ltd

Not applicable

Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide

Drugs for obstructive airway diseases

2025-10

AstraZeneca Canada Inc

Not applicable

Coagulation factors II (human), IX (human), VII (human), X (human), proteins C, S

Antihemorrhagics

2025-10

Octapharma Pharmazeutika Produktionsges M B H

Not applicable

Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B

Vaccines

2025-11

Merck Canada Inc

Not applicable

Daratumumab

Antineoplastic agents

2025-12

Janssen Inc

Not applicable

Delgocitinib

Other dermatological preparations

2026-05

Leo Pharma Inc

Part of an 'aligned review' with a health technology assessment organization

Drospirenone, estetrol monohydrate

Sex hormones and modulators of the genital system

2025-11

Searchlight Pharma Inc

Not applicable

Dupilumab

Other dermatological preparations

2025-11

Sanofi-Aventis Canada Inc

Not applicable

Dupilumab

Other dermatological preparations

2026-01

Sanofi-Aventis Canada Inc

Not applicable

Dupilumab

Other dermatological preparations

2026-02

Sanofi-Aventis Canada Inc

Not applicable

Durvalumab

Antineoplastic agents

2025-10

AstraZeneca Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Efgartigimod alfa

Immunosuppressants

2026-04

Argenx BV

Not applicable

Elinzanetant

Other gynecologicals

2025-10

Bayer Inc

Not applicable

Enfortumab vedotin

Antineoplastic agents

2026-04

Pfizer Canada ULC

Not applicable

Epcoritamab

Antineoplastic agents

2026-03

Abbvie Corporation

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Etonogestrel

Sex hormones and modulators of the genital system

2026-07

Organon Canada Inc.

Not applicable

Evolocumab

Lipid modifying agents

2026-06

Amgen Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Fish oil, medium-chain triglycerides, olive oil, soybean oil

Blood substitutes and perfusion solutions

2025-11

Fresenius Kabi Canada Ltd

Not applicable

Guselkumab

Immunosuppressants

2025-01

Janssen Inc

Not applicable

Inclisiran sodium

Lipid modifying agents

2026-04

Novartis Pharmaceuticals Canada Inc

Not applicable

Iopromide

Contrast media

2025-12

Bayer Inc

Being reviewed under the Submissions Relying on Third-Party Data Guidance

Ipilimumab

Antineoplastic agents

2025-11

Bristol-Myers Squibb Canada

Not applicable

Larotrectinib sulfate

Antineoplastic agents

2025-11

Bayer Inc

Not applicable

Lisocabtagene maraleucel

Antineoplastic agents

2026-03

Bristol-Myers Squibb Canada

Not applicable

Lisocabtagene maraleucel

Antineoplastic agents

2026-04

Bristol-Myers Squibb Canada

Not applicable

Lurbinectedin

Antineoplastic agents

2025-08

Jazz Pharmaceuticals Ireland Limited

Part of an 'aligned review' with a health technology assessment organization

Lutetium (177Lu) vipivotide tetraxetan

Therapeutic radiopharmaceuticals

2026-05

Novartis Pharmaceuticals Canada

Part of an 'aligned review' with a health technology assessment organization

Maralixibat chloride

Bile and liver therapy

2026-07

Mirum Pharmaceuticals, Inc.

Part of an 'aligned review' with a health technology assessment organization

Mavacamten

Cardiac therapy

2026-07

Bristol-Myers Squibb Canada

Being reviewed under the Priority Review Policy

Melatonin

Psycholeptics

2026-07

Neurim Pharmaceuticals Ltd.

Not applicable

mRNA encoding SARS-CoV-2 spike protein NTD-RBD subdomains

Vaccines

2026-07

Moderna Biopharma Canada Corporation

Not applicable

Nipocalimab

Immunosuppressants

2026-07

Janssen Inc

Not applicable

Nivolumab

Antineoplastic agents

2025-11

Bristol-Myers Squibb Canada

Not applicable

Obinutuzumab

Antineoplastic agents

2026-04

Hoffmann-La Roche Limited

Not applicable

Ocrelizumab

Immunosuppressants

2026-01

Hoffmann-la Roche Limited

Not applicable

Olezarsen sodium

Lipid modifying agents

2026-07

Theratechnologies Inc

Part of an 'aligned review' with a health technology assessment organization

Peginterferon alfa-2a

Immunostimulants

2026-02

Pharmaand GmbH

Not applicable

Pembrolizumab

Antineoplastic agents

2026-03

Merck Canada Inc

Not applicable

Pembrolizumab

Antineoplastic agents

2026-04

Merck Canada Inc

Not applicable

Pembrolizumab

Antineoplastic agents

2026-05

Merck Canada Inc

Not applicable

Pirtobrutinib

Antineoplastic agents

2026-01

Eli Lilly Canada Inc

Not applicable

Pirtobrutinib

Antineoplastic agents

2026-03

Eli Lilly Canada Inc

Not applicable

Respiratory syncytial virus prefusion F protein (RSVPreF3)

Vaccines

2026-01

GlaxoSmithKline Inc

Not applicable

Risankizumab

Immunosuppressants

2025-12

Abbvie Corporation

Part of an 'aligned review' with a health technology assessment organization

Ritonavir

Antivirals for systemic use

2026-01

Abbvie Corporation

Not applicable

Roflumilast

Antipsoriatics

2025-10

Arcutis Canada, Inc.

Not applicable

Roflumilast

Antipsoriatics

2026-02

Arcutis Canada, Inc.

Not applicable

Sacituzumab govitecan

Antineoplastic agents

2026-01

Gilead Sciences Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Sacituzumab govitecan

Antineoplastic agents

2026-01

Gilead Sciences Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Semaglutide

Drugs used in diabetes

2026-01

Novo Nordisk Canada Inc

Not applicable

Setmelanotide acetate

Antiobesity preparations, excluding diet products

2026-03

Rhythm Pharmaceuticals, Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Somapacitan

Pituitary and hypothalamic hormones and analogues

2026-06

Novo Nordisk Canada Inc

Not applicable

Talazoparib tosylate

Antineoplastic agents

2026-07

Pfizer Canada ULC

Not applicable

Talquetamab

Antineoplastic agents

2026-05

Janssen inc

Not applicable

Tapinarof

Antipsoriatics

2025-10

Organon Canada Inc.

Not applicable

Teclistamab

Antineoplastic agents

2026-04

Janssen Inc

Not applicable

Tirzepatide

Drugs used in diabetes

2025-12

Eli Lilly Canada Inc

Not applicable

Tirzepatide

Drugs used in diabetes

2026-02

Eli Lilly Canada Inc

Not applicable

Trastuzumab deruxtecan

Antineoplastic agents

2026-02

AstraZeneca Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Trastuzumab deruxtecan

Antineoplastic agents

2026-03

AstraZeneca Canada Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Trastuzumab deruxtecan

Antineoplastic agents

2026-03

AstraZeneca Canada Inc

Part of an 'aligned review' with a health technology assessment organization

Tucatinib

Antineoplastic agents

2026-06

Pfizer Canada ULC

Not applicable

Upadacitinib

Immunosuppressants

2026-02

Abbvie Corporation

Part of an 'aligned review' with a health technology assessment organization

Upadacitinib

Immunosuppressants

2026-06

Abbvie Corporation

Not applicable

Upadacitinib

Immunosuppressants

2026-07

Abbvie Corporation

Not applicable

Ustekinumab

Immunosuppressants

2026-02

Janssen Inc

Not applicable

Ustekinumab

Immunosuppressants

2026-05

Accord Healthcare Inc

Biosimilar

Part of an 'aligned review' with a health technology assessment organization

Venetoclax

Antineoplastic agents

2026-06

Abbvie Corporation

Not applicable

Zanidatamab

Antineoplastic agents

2026-05

Jazz Pharmaceuticals Ireland Limited

Not applicable

Page details

2026-09-01

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