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

Submissions currently under review: Supplemental new drug submissions for new uses
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)
Abemaciclib Antineoplastic agents 2021-03 Eli Lilly Canada Inc Not applicable
Adalimumab Immunosuppressants 2020-11 Sandoz Canada Incorporated Biosimilar
Anakinra Immunosuppressants 2020-05 Swedish Orphan Biovitrum AB (publ) Being reviewed under the Submissions Relying on Third-Party Data Guidance

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

Antihemophilic factor (recombinant) Antihemorrhagics 2021-03 Bayer Inc Not applicable
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 2020-11 Shire Pharma Canada ULC Not applicable
Axitinib Antineoplastic agents 2020-12 Pfizer Canada ULC Not applicable
Baricitinib Immunosuppressants 2020-12 Eli Lilly Canada Inc Not applicable
Belimumab Immunosuppressants 2020-10 GlaxoSmithKline Inc Not applicable
Betamethasone dipropionate, calcipotriol monohydrate Corticosteroids, dermatological preparations 2021-01 Leo Pharma Inc Not applicable
Bilastine Antihistamines for systemic use 2020-10 Aralez Pharmaceuticals Canada Inc Not applicable
Bisoprolol fumarate Beta blocking agents 2021-01 Sandoz Canada Incorporated Being reviewed under the Submissions Relying on Third-Party Data Guidance
Burosumab Drugs for treatment of bone diseases 2021-03 Kyowa Kirin Limited Being reviewed under the Priority Review Policy
Cabozantinib Antineoplastic agents 2020-12 Ipsen Biopharmaceuticals Canada Inc Not applicable
Cemiplimab Antineoplastic agents 2020-12 Sanofi-Aventis Canada Inc Not applicable
Dapagliflozin propanediol Drugs used in diabetes 2021-02 AstraZeneca Canada Inc Being reviewed under the Priority Review Policy
Daratumumab Antineoplastic agents 2021-03 Janssen Inc Not applicable
Deferiprone All other therapeutic products 2020-12 Chiesi Canada Corp. Not applicable
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 2020-09 ALK - Abello A/S Not applicable
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, inactivated poliovirus type I, inactivated poliovirus type II, inactivated poliovirus type III, pertactin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed Vaccines 2020-10 GlaxoSmithKline Inc Not applicable
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed Vaccines 2020-10 GlaxoSmithKline Inc Not applicable
Dupilumab Other dermatological preparations 2021-05 Sanofi-Aventis Canada Inc Not applicable
Empagliflozin Drugs used in diabetes 2021-01 Boehringer Ingelheim (Canada) Ltd Ltee Not applicable
Evolocumab Lipid modifying agents 2021-02 Amgen Canada Inc Not applicable
Glecaprevir, pibrentasvir Antivirals for systemic use 2021-02 AbbVie Corporation Not applicable
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 2021-01 BGP Pharma ULC Not applicable
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 2021-05 Seqirus UK Limited Not applicable
IncobotulinumtoxinA Muscle relaxants 2021-05 Merz Pharmaceuticals GmbH Not applicable
Isatuximab Antineoplastic agents 2020-10 Sanofi-Aventis Canada Inc Not applicable
Ivacaftor Other respiratory system products 2021-02 Vertex Pharmaceuticals (Canada) Incorporated Being reviewed under the Priority Review Policy
Lenvatinib mesylate Antineoplastic agents 2021-06 Eisai Limited Not applicable
Mepolizumab Drugs for obstructive airway diseases 2021-01 GlaxoSmithKline Inc Not applicable
Nivolumab Antineoplastic agents 2020-12 Bristol-Myers Squibb Canada Not applicable
Nivolumab Antineoplastic agents 2021-01 Bristol-Myers Squibb Canada Not applicable
Nivolumab Antineoplastic agents 2021-01 Bristol-Myers Squibb Canada Not applicable
Nivolumab Antineoplastic agents 2021-02 Bristol-Myers Squibb Canada Not applicable
Omalizumab Drugs for obstructive airway diseases 2020-08 Novartis Pharmaceuticals Canada Inc Not applicable
Ozanimod Immunosuppressants 2021-05 Celgene Inc Not applicable
Pembrolizumab Antineoplastic agents 2020-12 Merck Canada Inc Not applicable
Pembrolizumab Antineoplastic agents 2021-06 Merck Canada Inc Not applicable
Ranibizumab Opthalmologicals 2019-11 Novartis Pharmaceuticals Canada Inc Not applicable
Recombinant human papillomavirus types 6, 11, 16, 18, 31,33, 45, 52, 58 L1 protein Vaccines 2021-05 Merck Canada Inc Not applicable
Remdesivir Antivirals for systemic use 2021-04 Gilead Sciences Canada Inc For use in relation to COVID-19
Risankizumab Immunosuppressants 2021-05 Abbvie Corporation Not applicable
Romiplostim Antihemorrhagics 2020-10 Amgen Canada Inc Not applicable
Ruxolitinib phosphate Antineoplastic agents 2021-03 Novartis Pharmaceuticals Canada Inc Part of an 'aligned review' with a health technology assessment organization
Secukinumab Immunosuppressants 2021-05 Novartis Pharmaceuticals Canada Inc Not applicable
Semaglutide Drugs used in diabetes 2020-12 Novo Nordisk Canada Inc Not applicable
Sugammadex All other therapeutic products 2020-01 Merck Canada Inc Not applicable
Trastuzumab Antineoplastic agents 2021-02 BGP Pharma ULC Biosimilar
Upadacitinib Immunosuppressants 2020-12 AbbVie Corporation Not applicable
Upadacitinib Immunosuppressants 2021-02 AbbVie Corporation Not applicable
Varicella-zoster virus glycoprotein E (GE) Vaccines 2021-01 GlaxoSmithKline Inc Not applicable
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