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)
Abaloparatide Calcium homeostasis 2022-03 Endo Ventures Ltd New active substance
Abiraterone acetate, niraparib Endocrine therapy 2022-08 Janssen Inc Not applicable
Acalabrutinib Antineoplastic agents 2022-05 AstraZeneca Canada Inc Part of 'aligned review' with a health technology assessment organization
Acetaminophen Analgesics 2021-04 B. Braun Melsungen AG Being reviewed under the Submissions Relying on Third-Party Data Guidance
Acetaminophen, ibuprofen sodium dihydrate Analgesics 2022-06 Biosyent Pharma Inc Not applicable
Aflibercept Ophthalmologicals 2022-05 BGP Pharma ULC Biosimilar
Atogepant Analgesics 2021-07 Allergan Inc

New active substance

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

Bevacizumab Antineoplastic agents 2022-03 Celltrion Healthcare Co Ltd Biosimilar
Bimatoprost Ophthalmologicals 2022-02 Aequus Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Brincidofovir Antivirals for systemic use 2022-05 Chimerix Inc Extraordinary use submission
Cangrelor tetrasodium Antithrombotic agents 2021-11 Chiesi Farmaceutici S.p.A. 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
Carbidopa, levodopa Anti-parkinson drugs 2022-04 Auro Pharma Inc Not applicable
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

Ciltacabtagene autoleucel Antineoplastic agents 2022-04 Janssen Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Clascoterone Anti-acne preparations 2022-08 Sun Pharmaceutical Industries Limited New active substance

Part of 'aligned review' with a health technology assessment organization
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
Crisantaspase, recombinant Antineoplastic drugs 2021-11 Jazz Pharmaceuticals Ireland Limited Not applicable
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
Deucravacitinib Immunosuppressants 2022-01 Bristol-Myers Squibb Canada New active substance
Dexamethasone, levofloxacin Ophthalmologicals 2021-12 Xedition Pharmaceuticals Inc Not applicable
Diroximel fumarate Immunosuppressants 2020-07 Biogen Canada Inc New active substance
Dronabinol Antiemetics and antinauseants 2021-05 Tetra Bio-Pharma Inc. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live, attenuated) Vaccines 2021-10 Merck Canada Inc New active substance
Eculizumab Immunosuppressants 2022-07 Amgen Canada Inc

Biosimilar

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

Elasomeran, Omicron BA.4/BA.5 Vaccines 2022-09Footnote * ModernaTX, Inc. For use in relation to COVID-19
Enoxaparin sodium Antithrombotic agents 2021-12 Fresenius Kabi Canada Ltd 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
Erwinia L-asparaginase Antineoplastic agents 2021-09 Porton Biopharma Limited Being reviewed under the Priority Review Policy
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
Ferumoxytol Antianemic preparations 2022-03 Covis Pharma GmbH Part of 'aligned review' with a health technology assessment organization
Finerenone Diuretics 2021-12 Bayer Inc New active substance
Foscarbidopa, foslevodopa Anti-parkinson drugs 2022-07 AbbVie Corporation Not applicable
Gallium (68Ga) gozetotide Diagnostic radiopharmaceuticals 2021-02 Telix Pharmaceuticals (US) Inc

New active substance

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

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

Ganciclovir Ophthalmologicals 2019-02 Laboratoires Thea Not applicable
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

Hepatitis B surface antigen (recombinant) Vaccines 2022-02 VBI Vaccines Inc. New active substance
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

Lenacapavir sodium Antivirals for systemic use 2022-05 Gilead Sciences Canada Inc

New active substance

Being reviewed under the Priority Review Policy

Maribavir Antivirals for systemic use 2022-03 Takeda Canada Inc

New active substance

Being reviewed under the Priority Review Policy

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

Mavacamten Cardiac therapy 2022-01 Bristol-Myers Squibb Canada New active substance
Metformin hydrochloride Drugs used in diabetes 2022-07 Pharmaris Canada Inc Not applicable
Methotrexate Immunosuppressants 2022-05 Nordic Group B.V. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Methotrexate sodium Immunosuppressants 2021-11 Accord Healthcare Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Methylphenidate hydrochloride Psychoanaleptics 2021-01 KYE Pharmaceuticals Inc Not applicable
Molnupiravir Antivirals for systemic use 2021-08Footnote * Merck Canada Inc

For use in relation to COVID-19

New active substance

Mometasone furoate monohydrate, olopatadine hydrochloride Nasal preparations 2020-07 Glenmark Specialty SA Not applicable
Omicron BA.4/BA.5, tozinameran Vaccines 2021-09Footnote * BioNTech Manufacturing GmbH For use in relation to COVID-19
Pegcetaclopan Immunosuppressants 2022-06 Swedish Orphan Biovitrum AB (Publ)

New active substance

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

Being reviewed under the Priority Review Policy

Pegfilgrastim Immunostimulants 2022-05 Lupin Pharma Canada Limited Biosimilar
Pegfilgrastim Immunostimulants 2022-05 Nora Pharma Inc Biosimilar
Ranibizumab Ophthalmologicals 2021-09 Hoffmann-La Roche Limited Not applicable
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

Risperidone Psycholeptics 2022-03 Teva Canada Limited Part of 'aligned review' with a health technology assessment organization
Riltozinameran, tozinameran Vaccines 2022-07Footnote * BioNTech Manufacturing GmbH For use in relation to COVID-19

New active substance
Roflumilast Other dermatological preparations 2022-07 Arcutis Biotherapeutics, Inc Not applicable
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

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

Tirbanibulin Antibiotics and chemotherapy for dermatological use 2022-07 Avir Pharma Inc New active substance
Tirzepatide Drugs used in diabetes 2022-02 Eli Lilly Canada Inc

New active substance

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

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
Ubrogepant Analgesics 2021-10 Allergan Inc New active substance
Vericiguat Cardiac therapy 2021-01 Bayer Inc New active substance
Viable CVD 103-HgR Vaccines 2022-07 Emergent Travel Health Inc. Not applicable
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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