Submissions Under Review

Access the list of certain drug submissions currently under review. The submissions under review list is being implemented in a phased approach.

These submissions include new drug submissions (NDSs) containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada. This applies to submissions whose review started on or after April 1, 2015.

Certain submissions are also on the list if they were accepted into review on or after May 1, 2016. These submissions are:

  • NDSs
  • supplemental new drug submissions (SNDSs) for new uses

The entry for each submission includes its medicinal ingredient(s) and therapeutic area. The list is updated monthly.

The submissions under review list aims to enhance the transparency of our review processes. The list will help:

  • Canadians know whether a substance has been accepted for review in Canada
  • support Canadians in making better decisions about their health

Decisions

A substance is removed from these lists:

  • once a final decision is made and the submission is no longer under review
  • if the submission is cancelled

You can see if a submission has been approved in the Notice of Compliance Database.

You can find an explanation of the decision (positive or negative) or cancellation in the Regulatory Decision Summary (RDS). If applicable, a more detailed explanation is also contained in a Summary Basis of Decision document.

The RDS will be prepared and posted after a submission is removed from the list.

External Consultation Report 2016

The purpose of this report is to provide a summary of the results of the on-line questionnaire. The subject of the questionnaire was health product transparency initiatives.

Submissions under review list: new drug submissions
Medicinal Ingredient(s) Therapeutic Area
Alvimopan Drugs for constipation
Atezolizumab Antineoplastic agents
Baricitinib Antiinflammatory and antirheumatic products
Botulinum antitoxin serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins
Brexpiprazole Psycholeptics
Brodalumab Immunosuppressants
Buprenorphine hydrochloride Other nervous system drugs
C1 esterase inhibitor (human) Immunosuppressants
Cefixime Antibacterials for systemic use
Cinnarizine, dimenhydrinate Other nervous system drugs
Cyclosporin Ophthalmologicals
Daclizumab Immunosuppressants
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens
Eliglustat tartrate Other alimentary tract and metabolism products
Eluxadoline Drugs for functional gastrointestinal disorders
Etanercept Immunosuppressants
Ferric derisomaltose Antianemic preparations
Fibrinogen (human) Antihemorrhagics
Flibanserin Other gynecologicals
Florbetaben (18F) Diagnostic radiopharmaceuticals
Fluticasone propionate Drugs for obstructive airway diseases
Follitropin delta Sex hormones and modulators of the genital system
Gadoteric acid Contrast media
Human insulin (recombinant) Drugs used in diabetes
Immune globulin (human) Immune sera and immunoglobulins
Insulin degludec Drugs used in diabetes
Iodine Contrast media
Iron dextran Antianemic preparations
Lixisenatide Drugs used in diabetes
Lonoctocog alfa Antihemorrhagics
Mercaptamine bitartrate Other alimentary tract and metabolism products
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents
Migalastat hydrochloride Other alimentary tract and metabolism products
Necitumumab Antineoplastic agents
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines
Nitisinone Other alimentary tract and metabolism products
Obeticholic acid Bile and liver therapy
Ocrelizumab Immunosuppressants
Ocrelizumab Immunosuppressants
Oxycodone Analgesics
Ozenoxacin Antibiotics and chemotherapy for dermatological use
Pegaspargase Antineoplastic agents
Peramivir Antivirals for systemic use
Propiverine hydrochloride Urologicals
Romosozumab Drugs for treatment of bone diseases
Salbutamol sulfate Drugs for obstructive airway diseases
Sarilumab Immunosuppressants
Suvorexant Psycholeptics
Tenofovir alafenamide hemifumarate Antivirals for systemic use
Vernakalant hydrochloride Cardiac therapy
Von Willebrand factor (human) Antihemorrhagics
 
Submissions under review list: supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area
Adalimumab Immunosuppressants
Anakinra Immunosuppressants
Apixaban Antithrombotic agents
Blinatumomab Antineoplastic agents
C1 esterase inhibitor (human) Other hematological agents
Canagliflozin Drugs used in diabetes
Canakinumab Immunosuppressants
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use
Crizotinib Antineoplastic agents
Dabrafenib Antineoplastic agents
Daratumumab Antineoplastic agents
Eltrombopag olamine Antihemorrhagics
Empagliflozin Drugs used in diabetes
Eribulin mesylate Antineoplastic agents
Erlotinib hydrochloride Antineoplastic agents
Etanercept Immunosuppressants
Glycopyrronium bromide, indacaterol maleate Drugs for obstructive airway diseases
Golimumab Immunosuppressants
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines
Ivacaftor, lumacaftor Other respiratory system products
Lacosamide Antiepileptics
Lenvatinib mesylate Antineoplastic agents
Leuprolide acetate Endocrine therapy
Linagliptin Drugs used in diabetes
Linagliptin, metformin hydrochloride Drugs used in diabetes
Liraglutide Drugs used in diabetes
Lurasidone hydrochloride Psycholeptics
Nadroparin calcium Antithrombotic agents
Nivolumab Antineoplastic agents
Omalizumab Drugs for obstructive airway diseases
Ombitasvir, paritaprevir, ritonavir Antivirals for systemic use
Palbociclib Antineoplastic agents
Panitumumab Antineoplastic agents
Rufinamide Antiepileptics
Simeprevir Antivirals for systemic use
Trametinib Antineoplastic agents

If you have further questions, please email us at OPPRS_enquiries@hc-sc.gc.ca.

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