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

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)
Acetaminophen, ibuprofen sodium dihydrate Analgesics 2022-06 Biosyent Pharma Inc Not applicable
Aflibercept Ophthalmologicals 2022-05 BGP Pharma ULC Biosimilar
Andusomeran Vaccines 2023-06Footnote * Moderna Biopharma Canada Corporation For use in relation to COVID-19
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
Avatrombopag maleate Antihemorrhagics 2021-06 Swedish Orphan Biovitrum AB (publ)

New active substance

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

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
Brincidofovir Antivirals for systemic use 2022-05 Chimerix Inc Extraordinary use submission
Calaspargase pegol Antineoplastic agents 2022-11 Servier Canada Inc New active substance
Cannabidiol Antiepileptics 2023-01 GW Research Limited Not applicable
Capivasertib Antineoplastic agents 2023-06 AstraZeneca Canada Inc New active substance
Captopril Agents acting on the renin-angiotensin system 2021-04 Ethypharm Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
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

Cefditoren pivoxil Antibacterials for systemic use 2022-07 Orimed Pharma Inc New active substance
Denosumab
(2 submissions under review)
Drugs for treatment of bone diseases 2023-03 Sandoz Canada Incorporated Biosimilar
Dexamethasone, levofloxacin Ophthalmologicals 2021-12 Xedition Pharmaceuticals Inc Not applicable
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
Efgartigimod alfa Immunosuppressants 2022-11 Argenx BV New active substance
Elranatamab Antineoplastic agents 2023-04 Pfizer Canada ULC

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Epcoritamab Antineoplastic agents 2023-02 Abbvie Corporation

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Estradiol, norethindrone acetate, relugolix Pituitary, hypothalamic hormones and analogues 2022-11 Myovant Sciences GmbH New active substance
Estradiol, norethindrone acetate, relugolix Pituitary, hypothalamic hormones and analogues 2022-12 Myovant Sciences GmbH Not applicable
Etranacogene dezaparvovec Other hematological agents 2023-04 CSL Behring Canada Inc

New active substance

Being reviewed under the Priority Review Policy

Etrasimod L-arginine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2023-03 Pfizer Canada ULC New active substance
Evinacumab Lipid modifying agents 2023-03 Ultragenyx Pharmaceutical Inc

New active substance

Part of 'aligned review' with a health technology assessment organization
Ferric carboxymaltose Antianemic preparations 2023-04 Vifor (International) Inc New active substance
Ferric maltol Antianemic preparations 2022-06 KYE Pharmaceuticals Inc New active substance
Fidanacogene elaparvovec Antihemorrhagics 2023-06 Pfizer Canada ULC

New active substance

Being reviewed under the Priority Review Policy

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

Filgrastim (r-metHuG-CSF) Immunostimulants 2023-01 Curateq Biologics Private Limited

Biosimilar

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

Gefapixant Cough and cold preparations 2021-12 Merck Canada Inc New active substance
Inebilizumab Immunosuppressants 2023-02 Horizon Therapeutics Ireland DAC New active substance
Influenza virus type A (H1N1) Vaccines 2022-10 Sanofi Pasteur Limited Not applicable
Insulin icodec Drugs used in diabetes 2023-05 Novo Nordisk Canada Inc New active substance
Landiolol hydrochloride Beta blocking agents 2022-02 Trimedic Therapeutics Inc.

New active substance

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

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
Lidocaine hydrochloride, nifedipine Vasoprotectives 2022-11 Seaford Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Masitinib mesylate Antineoplastic agents 2022-05 AB Science S.A.

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

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

Meropenem trihydrate Antibacterials for systemic use 2023-03 B. Braun Medical Inc Not applicable
Methotrexate Immunosuppressants 2022-05 Nordic Group B.V. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Methylphenidate hydrochloride Psychoanaleptics 2021-01 KYE Pharmaceuticals Inc Not applicable
Metreleptin Other alimentary tract and metabolism products 2023-04 Amryt Pharmaceuticals DAC

New active substance

Being reviewed under the Priority Review Policy

Nivolumab, relatlimab Antineoplastic agents 2022-09 Bristol-Myers Squibb Canada New active substance
Odevixibat Bile and liver therapy 2023-05 Medison Pharma Canada Inc.

New active substance

Being reviewed under the Priority Review Policy

Olipudase alfa Other alimentary tract and metabolism products 2023-06 Sanofi-Aventis Canada Inc

New active substance

Being reviewed under the Priority Review Policy

Osilodrostat phosphate Corticosteroids for systemic use 2023-02 Recordati Rare Diseases Canada Inc New active substance
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
Ranibizumab Ophthalmologicals 2022-12 Teva Canada Limited Biosimilar
Raxtozinameran Vaccines 2023-06Footnote * BioNTech Manufacturing GmbH For use in relation to COVID-19
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

RelabotulinumtoxinA Muscle relaxants 2023-03 Galderma SA Not applicable
Relugolix Endocrine therapy 2022-12 Myovant Sciences GmbH New active substance
Respiratory syncytial virus prefusion F protein (RSVPreF3) Vaccines 2022-11 GlaxoSmithKline Inc New active substance
Rimegepant Analgesics 2023-01 Pfizer Canada ULC New active substance
Risperidone Psycholeptics 2022-03 Teva Canada Limited Part of 'aligned review' with a health technology assessment organization
Risperidone Psycholeptics 2022-12 Laboratorios Farmaceuticos Rovi, S.A. Not applicable
Ritlecitinib Other dermatological preparations 2023-02 Pfizer Canada ULC New active substance
Ropivacaine hydrochloride Anesthetics 2023-05 Formative Pharma Inc. Being reviewed under the Submissions Relying on Third-Party Data Guidance
RSV F antigen 847A, recombinant, RSV F antigen 847B, recombinant Vaccines 2023-03 Pfizer Canada ULC Not applicable
Ruxolitinib phosphate Other dermatological preparations 2023-03 Incyte Corporation Not applicable
Sabizabulin Antivirals for systemic use 2022-11Footnote * Veru Inc.

New active substance

For use in relation to COVID-19

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

Smallpox vaccine dried Vaccines 2023-02 Emergent Product Development Gaithersburg Inc. Extraordinary use submission
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
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
Tremelimumab Antineoplastic agents 2022-05 AstraZeneca Canada Inc New active substance
Ustekinumab Immunosuppressants 2023-01 Jamp Pharma Corporation Biosimilar
Ustekinumab Immunosuppressants 2023-03 Amgen Canada Inc

Biosimilar

Part of ‘aligned review’ with a health technology assessment organization
Vutrisiran Other nervous system drugs 2022-12 Alnylam Netherlands B.V. New active substance
Whole virion inactivated coronavirus Vaccines 2021-07Footnote * Vaccigen Ltd

For use in relation to COVID-19

New active substance

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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