Drug and health product 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
Anthrax immunoglobulin (human) Immune sera and immunoglobulins
Atezolizumab Antineoplastic agents
Baricitinib Antiinflammatory and antirheumatic products
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
Defibrotide Antithrombotic agents
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
Fluoxetine hydrochloride Psychoanaleptics
Fluticasone propionate Drugs for obstructive airway diseases
Fluticasone proprionate, salmeterol xinafoate Drugs for obstructive airway diseases
Follitropin delta Sex hormones and modulators of the genital system
Glycopyrrolate Drugs for functional gastrointestinal disorders
Guselkumab Immunosuppressants
Human insulin (recombinant) Drugs used in diabetes
Immune globulin (human) Immune sera and immunoglobulins
Insulin degludec Drugs used in diabetes
Insulin lispro Drugs used in diabetes
Iodine Contrast media
Iron dextran Antianemic preparations
Lifitegrast Ophthalmologicals
Lixisenatide Drugs used in diabetes
Lorcaserin hydrochloride Antiobesity preparations, excluding diet products
Mercaptamine bitartrate Other alimentary tract and metabolism products
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents
Midostaurin Antineoplastic agents
Migalastat hydrochloride Other alimentary tract and metabolism products
Necitumumab Antineoplastic agents
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines
Netupitant, palonosetron hydrochloride Antiemetics and antinauseants
Nusinersen Other nervous system drugs
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
Prasterone Anabolic agents for systemic use
Romosozumab Drugs for treatment of bone diseases
Salbutamol sulfate Drugs for obstructive airway diseases
Suvorexant Psycholeptics
Tenofovir alafenamide hemifumarate Antivirals for systemic use
Varicella-zoster virus glycoprotein E (GE) Vaccines
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
Aripiprazole Psycholeptics
Blinatumomab Antineoplastic agents
C1 esterase inhibitor (human) Other hematological agents
Canagliflozin Drugs used in diabetes
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
Eptacog alfa Antihemorrhagics
Eribulin mesylate Antineoplastic agents
Erlotinib hydrochloride Antineoplastic agents
Etanercept Immunosuppressants
Fulvestrant Endocrine therapy
Glycopyrronium bromide, indacaterol maleate Drugs for obstructive airway diseases
Golimumab Immunosuppressants
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2),
haemagglutinin-strain B
Vaccines
Immune globulin (human) Immune sera and immunoglobulins
Ivacaftor, lumacaftor Other respiratory system products
Lacosamide Antiepileptics
Ledipasvir, sofosbuvir Antivirals for systemic use
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
Mifepristone, misoprostol Sex hormones and modulators of the genital system
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
Pembrolizumab Antineoplastic agents
Pneumococcal polysaccharide serotypes 1, 4, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D carrier protein, pneumococcal polysaccharide serotype 18C conjugated to tetanus toxoid carrier protein, pneumococcal polysaccharide serotype 19F conjugated to diphtheria toxoid carrier protein Vaccines
Ranibizumab Ophthalmologicals
Rufinamide Antiepileptics
Simeprevir Antivirals for systemic use
Sofosbuvir, velpatasvir Antivirals for systemic use
Thioguanine Antineoplastic agents
Tinzaparin sodium Antithrombotic agents
Trametinib Antineoplastic agents

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

Report a problem or mistake on this page
Please select all that apply:

Privacy statement

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: