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)
Abrocitinib Other dermatological preparations 2020-12 Pfizer Canada ULC

New active substance

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
Adalimumab Immunosuppressants 2021-02 Jamp Pharma Corporation Biosimilar
Aducanumab Other nervous system drugs 2021-06 Biogen Canada Inc New active substance
Amivantamab Antineoplastic agents 2021-07 Janssen Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Aprotinin Antihemorrhagics 2021-02 Nordic Group B.V. Not applicable
Asciminib hydrochloride Antineoplastic agents 2021-08 Novartis Pharmaceuticals Canada Inc

New active substance

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

Atogepant Analgesics 2021-07 Allergan Inc New active substance
Avacopan Immunosuppressants 2021-05 Vifor Fresenius Medical Care Renal Pharma Ltd New active substance
Avatrombopag maleate Antihemorrhagics 2021-06 Swedish Orphan Biovitrum AB (publ) New active substance
BamlanivimabFootnote ** Immune sera and immunoglobulins 2021-06Footnote * Eli Lilly Canada Inc

For use in relation to COVID-19

New active substance

Belumosudil mesylate Immunosuppressants 2021-01 Kadmon Pharmaceuticals LLC

New active substance

Being reviewed under the Priority Review Policy

Belzutifan Antineoplastic agents 2021-09 Merck Canada Inc New active substance
Bendamustine hydrochloride Antineoplastic agents 2021-03 Pfizer Canada ULC Not applicable
Bendamustine hydrochloride Antineoplastic agents 2021-07 Dr Reddys Laboratories Ltd Not applicable
Berotralstat hydrochloride Other hematological agents 2021-08 BioCryst Pharmaceuticals Inc New active substance
Bimekizumab Immunosuppressants 2021-04 UCB Canada Inc

New active substance

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

Bupivacaine, meloxicam Antiinflammatory and antirheumatic products 2020-01 Heron Therapeutics, Inc. Not applicable
Cangrelor tetrasodium Antithrombotic agents 2021-11 Chiesi Farmaceutici S.p.A. New active substance
Capmatinib dihydrochloride Antineoplastic agents 2021-09 Novartis Pharmaceuticals Canada Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

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

Captopril Agents acting on the renin-angiotensin system 2021-04 Ethypharm Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Cariprazine hydrochloride Psycholeptics 2021-06 Allergan Inc New active substance
Casirivimab, imdevimabFootnote ** Immune sera and immunoglobulins 2021-09Footnote * Hoffmann-La Roche Limited

For use in relation to COVID-19

New active substance

Cevimeline hydrochloride Other nervous system drugs 2020-09 KYE Pharmaceuticals Inc New active substance
Cilgavimab, tixagevimab Immune sera and immunoglobulins 2021-11Footnote * AstraZeneca Canada Inc

For use in relation to COVID-19

New active substance

Cilostazol Antithrombotic agents 2021-02 KYE Pharmaceuticals Inc

New active substance

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

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
Coronavirus-like particle (CoVLP) Vaccines 2021-08Footnote * Medicago Inc

For use in relation to COVID-19

New active substance

Crisantaspase, recombinant Antineoplastic drugs 2021-11 Jazz Pharmaceuticals Ireland Limited Not applicable
Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F Vaccines 2021-07 Pfizer Canada ULC New active substance
Daridorexant hydrochloride Other nervous system drugs 2021-10 Idorsia Pharmaceuticals Ltd New active substance
Dexamethasone, levofloxacin Ophthalmologicals 2021-12 Xedition Pharmaceuticals Inc Not applicable
Diamorphine hydrochloride Other nervous system drugs 2021-08 Pharmascience Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Difelikefalin Antipruritics, including antihistamines, anesthetics, etc. 2021-10 Vifor Fresenius Medical Care Renal Pharma Ltd New active substance
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
Enoxaparin sodium Antithrombotic agents 2021-12 Fresenius Kabi Canada Ltd

Biosimilar

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

Erwinia L-asparaginase Antineoplastic agents 2021-09 Porton Biopharma Limited Being reviewed under the Priority Review Policy
Etanercept Immunosuppressants 2020-02 Lupin Pharma Canada Limited Biosimilar
Etesevimab Immune sera and immunoglobulins 2021-09Footnote * Eli Lilly Canada Inc

New active substance

For use in relation to COVID-19

Faricimab Ophthalmologicals 2021-08 Hoffmann-La Roche Limited New active substance
Favipiravir Antivirals for systemic use 2021-09Footnote * Dr Reddys Laboratories Ltd

For use in relation to COVID-19

New active substance

Finerenone Diuretics 2021-12 Bayer Inc Not applicable
Gallium Ga 68-PSMA-11 Diagnostic radiopharmaceuticals 2021-02 Telix Pharmaceuticals (US) Inc

New active substance

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

Gallium oxodotreotide Diagnostic radiopharmaceuticals 2021-05 Canadian Molecular Imaging Probe Consortium (CanProbe)

New active substance

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 Not applicable
Human insulin (recombinant) Drugs used in diabetes 2021-05 Baxter Corporation Biosimilar
Hyaluronidase (human recombinant), immunoglobulin (human), Immune sera and immunoglobulins 2021-02 Takeda Canada Inc

New active substance

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

Insulin glargine Drugs used in diabetes 2021-06 BGP Pharma ULC Biosimilar
LetibotulinumtoxinA Muscle relaxants 2021-08 Croma Aesthetics Canada, Ltd. Not applicable
Lisocabtagene maraleucel Antineoplastic agents 2021-02 Celgene Inc New active substance
Lumasiran Other alimentary tract and metabolism products 2021-08 Alnylam Netherlands B.V.

New active substance

Being reviewed under the Priority Review Policy

Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2021-03 Avir Pharma Inc Not applicable
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
Mogamulizumab Antineoplastic agents 2021-05 Kyowa Kirin, Inc.

New active substance

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

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
NVX-CoV2373 Vaccines 2021-08Footnote * Novavax Inc.

For use in relation to COVID-19

New active substance

Palovarotene Other drugs for disorders of the musculo-skeletal system 2021-07 Ipsen Biopharmaceuticals Canada Inc

New active substance

Being reviewed under the Priority Review Policy

Pegvaliase Other alimentary tract and metabolism products 2021-06 BioMarin International Limited New active substance
Pralsetinib Antineoplastic agents 2021-06 Hoffmann-La Roche Limited Being reviewed under the Notice of Compliance with Conditions Guidance
Ranibizumab Ophthalmologicals 2021-05 Samsung Bioepis Co., Ltd 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

SARS-CoV-2 prefusion spike delta TM protein, recombinant Vaccines 2021-07Footnote * Sanofi Pasteur Limited For use in relation to COVID-19
Selinexor Antineoplastic agents 2021-08 Forus Therapeutics Inc New active substance
Selumetinib Antineoplastic agents 2020-11 AstraZeneca Canada Inc

New active substance

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

Sodium phenylbutyrate, ursodoxicoltaurine Other nervous system drugs 2021-08 Amylyx Pharmaceuticals Inc.

New active substance

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

SotrovimabFootnote ** Immune sera and immunoglobulins 2021-10Footnote * GlaxoSmithKline Inc

For use in relation to COVID-19

New active substance

Tebentafusp Antineoplastic agents 2021-12 Immunocore Ireland Limited Not applicable
Tezepelumab Drugs for obstructive airway diseases 2021-10 AstraZeneca Canada Inc

New active substance

Trastuzumab Antineoplastic agents 2018-02 Not available Not available
Trastuzumab Antineoplastic agents 2020-04 Samsung Bioepis Co., Ltd Biosimilar
Trastuzumab Antineoplastic agents 2021-08 Prestige BioPharma Ltd. Biosimilar

Trastuzumab

(2 submissions under review)

Antineoplastic agents 2017-11 Not available Not available
Ubrogepant Analgesics 2021-10 Allergan Inc New active substance
Vericiguat Cardiac therapy 2021-01 Bayer Inc 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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