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
Ad26.COV2.S (recombinant)Footnote ** Vaccines 2021-06Footnote * Janssen Inc

For use in relation to COVID-19

New active substance

Adalimumab Immunosuppressants 2021-02 Jamp Pharma Corporation Biosimilar
Adalimumab Immunosuppressants 2021-03 Celltrion Healthcare Co Ltd Biosimilar
Aducanumab Other nervous system drugs 2021-06 Biogen Canada Inc New active substance
Alfa 1-proteinase inhibitor (human) Antihemorrhagics 2021-01 Takeda Canada Inc Not applicable
Amivantamab Antineoplastic agents 2021-07 Janssen Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Anifrolumab Immunosuppressants 2020-12 AstraZeneca Canada Inc New active substance
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
Avalglucosidase alfa Other alimentary tract and metabolism 2020-11 Sanofi-Aventis Canada Inc New active substance
Avanafil Urologicals 2019-06 Acerus Pharmaceuticals Corporation 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
Bevacizumab Antineoplastic agents 2020-07 BGP Pharma ULC Biosimilar

Bevacizumab

(2 submissions under review)

Antineoplastic agents 2021-02 Samsung Bioepis Co., Ltd Biosimilar
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
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
ChAdOx1-S (recombinant)Footnote ** Vaccines 2021-06Footnote * AstraZeneca Canada Inc

For use in relation to COVID-19

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

Copanlisib dihydrochloride Antineoplastic agents 2021-08 Bayer Inc New active substance
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

Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F Vaccines 2021-01 Merck Canada Inc New active substance
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
Diamorphine hydrochloride Other nervous system drugs 2021-08 Pharmascience Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Diroximel fumarate Immunosuppressants 2020-07 Biogen Canada Inc New active substance
Dostarlimab Antineoplastic agents 2021-04 GlaxoSmithKline 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

Dronabinol Antiemetics and antinauseants 2021-05 Tetra Bio-Pharma Inc. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Drospirenone Sex hormones and modulators of the genital system 2021-02 Duchesnay Inc Not applicable
Enfortumab vedotin Antineoplastic agents 2021-05 Seagen Inc.

New active substance

Being reviewed under the Priority Review Policy

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

Filgrastim (r-metHuG-CSF) Immunostimulants 2019-03 Tanvex Biopharm USA, Inc Biosimilar
Finerenone Diuretics 2021-04 Bayer Inc New active substance
Fostemsavir tromethamine Antivirals for systemic use 2021-04 ViiV Healthcare ULC

New active substance

Being reviewed under the Priority Review Policy

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
Goserelin acetate Endocrine therapy 2020-07 JAMP Pharma Corporation 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

Infliximab Immunosuppressants 2021-02 Pfizer Canada ULC Biosimilar
Insulin aspart Drugs used in diabetes 2020-12 BGP Pharma ULC Biosimilar
Insulin glargine Drugs used in diabetes 2021-06 BGP Pharma ULC Biosimilar
Insulin lispro Drugs used in diabetes 2020-11 Eli Lilly Canada Inc Not applicable
LetibotulinumtoxinA Muscle relaxants 2021-08 Croma Aesthetics Canada, Ltd. Not applicable
Leuprolide mesylate Endocrine therapy 2021-01 Accord Healthcare Inc 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

Macitentan, tadalafil Antihypertensives 2020-12 Janssen Inc Not applicable
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2021-03 Avir Pharma Inc Not applicable
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
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
Recombinant haemagglutinin-strain A (H1N1) virus-like particles, Recombinant haemagglutinin-strain A (H3N2) virus-like particles, Recombinant haemagglutinin-strain B (Victoria lineage) virus-like particles, Recombinant haemagglutinin-strain B (Yamagata lineage) virus-like particles Vaccines 2019-09 Medicago Inc New active substance
Regdanvimab Immune sera and immunoglobulins 2021-05Footnote * Celltrion HealthCare Co Ltd

For use in relation to COVID-19

New active substance

Roxadustat Antianemic preparations 2020-03 AstraZeneca Canada Inc

New active substance

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

Sacituzumab govitecan Antineoplastic agents 2021-03 Gilead Sciences Canada Inc

New active substance

Being reviewed under the Priority Review Policy

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
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

Semaglutide Drugs used in diabetes 2021-01 Novo Nordisk Canada Inc Not applicable
Sodium phenylbutyrate, ursodoxicoltaurine Other nervous system drugs 2021-08 Amylyx Pharmaceuticals Inc. New active substance
Somatrogon Pituitary, hypothalamic hormones and analogues 2020-12 Pfizer Canada ULC New active substance
SotrovimabFootnote ** Immune sera and immunoglobulins 2021-10Footnote * GlaxoSmithKline Inc

For use in relation to COVID-19

New active substance

Tecovirimat monohydrate Antivirals for systemic use 2021-02 SIGA Technologies, Inc.

Extraordinary use submission

New active substance

Tralokinumab Other dermatological preparations 2020-12 Leo Pharma 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 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
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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