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)
Abiraterone acetate, niraparib Endocrine therapy 2022-08 Janssen Inc Not applicable
Acetaminophen, ibuprofen sodium dihydrate Analgesics 2022-06 Biosyent Pharma Inc Not applicable
Aflibercept Ophthalmologicals 2022-05 BGP Pharma ULC Biosimilar
Andexanet alfa All other therapeutic products 2022-10 AstraZeneca 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

Avatrombopag maleate Antihemorrhagics 2021-06 Swedish Orphan Biovitrum AB (publ)

New active substance

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

BamlanivimabFootnote ** Immune sera and immunoglobulins 2021-06Footnote * Eli Lilly Canada Inc

For use in relation to COVID-19

New active substance

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

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
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
Cenobamate Antiepileptics 2022-07 Endo Ventures Ltd

New active substance

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

Clascoterone Anti-acne preparations 2022-08 Sun Pharmaceutical Industries Limited

New active substance

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

Concizumab Antihemorrhagics 2022-09 Novo Nordisk Canada Inc

New active substance

Being reviewed under the Priority Review Policy

Concizumab Antihemorrhagics 2022-09 Novo Nordisk Canada Inc Not applicable
Copper, manganese sulfate, selenious acid, sodium iodide, zinc sulfate Blood substitutes and perfusion solutions 2021-03 Sandoz Canada Incorporated Being reviewed under the Submissions Relying on Third-Party Data Guidance
Daprodustat Antianemic preparations 2022-05 GlaxoSmithKline Inc

New active substance

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

Daridorexant hydrochloride Other nervous system drugs 2021-10 Idorsia Pharmaceuticals Ltd New active substance
Dexamethasone, levofloxacin Ophthalmologicals 2021-12 Xedition Pharmaceuticals Inc Not applicable
Dronabinol Antiemetics and antinauseants 2021-05 Tetra Bio-Pharma Inc. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Eculizumab Immunosuppressants 2022-07 Amgen Canada Inc

Biosimilar

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

Efgartigimod alfa Immunosuppressants 2022-11 Argenx BV New active substance
Enoxaparin sodium Antithrombotic agents 2022-09 Baxter Corporation

Biosimilar

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

Enterococcus faecalis inactivated, Escherichia coli inactivated, Klebsiella pneumoniae inactivated, Proteus vulgaris inactivated Vaccines 2022-05 Red Leaf Medical Inc New active substance
Epcoritamab Antineoplastic agents 2023-02 Abbvie Corporation

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Erwinia L-asparaginase Antineoplastic agents 2021-09 Porton Biopharma Limited Being reviewed under the Priority Review Policy
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
Etesevimab Immune sera and immunoglobulins 2021-09Footnote * Eli Lilly Canada Inc

New active substance

For use in relation to COVID-19

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

Ferric maltol Antianemic preparations 2022-06 KYE Pharmaceuticals 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

Foscarbidopa, foslevodopa Anti-parkinson drugs 2022-07 AbbVie Corporation Not applicable
Gallium (68Ga) gozetotide Diagnostic radiopharmaceuticals 2022-06 Advanced Accelerator Applications USA, Inc.

New active substance

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

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

Gefapixant Cough and cold preparations 2021-12 Merck Canada Inc New active substance
Glofitamab Antineoplastic agents 2022-07 Hoffmann-La Roche Limited

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Inebilizumab Immunosuppressants 2023-02 Horizon Therapeutics Ireland DAC New active substance
Influenza virus type A (H1N1) Vaccines 2022-10 Sanofi Pasteur Limited Not applicable
Isotretinoin Anti-acne preparations 2022-08 Sun Pharmaceutical Industries Limited Part of 'aligned review' with a health technology assessment organization
JZP-258 Other nervous system drugs 2022-07 Jazz Pharmaceuticals Ireland Limited Not applicable
Landiolol hydrochloride Beta blocking agents 2022-02 Trimedic Therapeutics Inc.

New active substance

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

Lidocaine hydrochloride, nifedipine Vasoprotectives 2022-11 Seaford Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Maralixibat chloride Bile and liver therapy 2023-01 Mirum Pharmaceuticals, Inc.

New active substance

Being reviewed under the Priority Review Policy

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

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

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
Mirikizumab Immunosuppressants 2022-09 Eli Lilly Canada Inc

New active substance

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

Molnupiravir Antivirals for systemic use 2021-08Footnote * Merck Canada Inc

For use in relation to COVID-19

New active substance

Nirsevimab Immune sera and immunoglobulins 2022-12 AstraZeneca Canada Inc

New active substance

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

Nivolumab, relatlimab Antineoplastic agents 2022-09 Bristol-Myers Squibb Canada New active substance
Osilodrostat phosphate Corticosteroids for systemic use 2023-02 Recordati Rare Diseases Canada Inc New active substance
Pegfilgrastim Immunostimulants 2022-05 Lupin Pharma Canada Limited Biosimilar
Pegfilgrastim Immunostimulants 2022-05 Nora Pharma Inc Biosimilar
Ranibizumab Ophthalmologicals 2022-12 Teva Canada Limited Biosimilar
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

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
Roflumilast Other dermatological preparations 2022-07 Arcutis Biotherapeutics, Inc 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

SARS-CoV-2 prefusion spike delta TM protein, recombinant Vaccines 2021-07Footnote * Sanofi Pasteur Limited

For use in relation to COVID-19

New active substance

SARS-CoV-2 prefusion spike delta TM protein, recombinant Vaccines 2022-12Footnote * Sanofi Pasteur Limited

For use in relation to COVID-19

New active substance

Setmelanotide acetate Antiobesity preparations, excluding diet products 2022-11 Rhythm Pharmaceuticals, Inc

New active substance

Being reviewed under the Priority Review Policy

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

Smallpox vaccine dried Vaccines 2023-02 Emergent Product Development Gaithersburg Inc. Extraordinary use submission
Somapacitan Pituitary, hypothalamic hormones and analogues 2022-09 Novo Nordisk Canada Inc New active substance
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

Spesolimab Immunosuppressants 2022-09 Boehringer Ingelheim (Canada) Ltd Ltee

New active substance

Being reviewed under the Priority Review Policy

Teclistamab Antineoplastic agents 2022-12 Janssen Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Tirbanibulin Antibiotics and chemotherapy for dermatological use 2022-07 Avir Pharma Inc New active substance
Trastuzumab Antineoplastic agents 2018-02 Not available Not available
Trastuzumab Antineoplastic agents 2021-08 Prestige BioPharma Ltd. Biosimilar
Trastuzumab
(2 submissions under review)
Antineoplastic agents 2017-11 Not available Not available
Tremelimumab Antineoplastic agents 2022-05 AstraZeneca Canada Inc New active substance
Ustekinumab Immunosuppressants 2023-01 Jamp Pharma Corporation Biosimilar
Vericiguat Cardiac therapy 2021-01 Bayer Inc New active substance
Viable CVD 103-HgR Vaccines 2022-07 Emergent Travel Health Inc. Not applicable
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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