Generic submissions under review

How to access a list of generic drug submissions currently under review.

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About the Generic Submissions Under Review (GSUR) List

The Generic Submissions Under Review (GSUR) List helps to make our review processes more transparent. The list will help Canadians understand if generic versions of brand name drugs are currently under review in Canada.

The GSUR List was announced as part of Phase III of the Submissions Under Review (SUR) List initiative.

The GSUR List includes abbreviated new drug submissions (ANDSs) accepted into review on or after October 1, 2018.

Finding information on the list

The GSUR List entries each include the:

The list is updated monthly.

Decisions

The number of ANDSs under review with Health Canada in any given month changes depending on

  • ANDSs that are newly accepted for review
  • ANDSs that are cancelled by the sponsor (company)
  • Final decisions that are made on ANDSs (positive or negative)

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

Health Canada announced in August 2018 that it will publish regulatory decision summaries for final positive and negative decisions for certain prescription generic drug submissions that might be of interest to stakeholders. These can be found using the Regulatory Decision Summary search tool in the Drug and Health Product Register.

Access to generic drugs

Many factors affect Canadians' access to generic drugs. For more information about generic drug products and submissions, please see the Fact Sheet on Access to Generic Drugs in Canada.

External consultations

Health Canada is now seeking feedback on the possible impacts and uses to stakeholders of adding sponsor (company) names to the Generic Submissions Under Review List.

Several external consultations have been held as the SUR List initiative has evolved. In 2017, an external consultation was held on five transparency proposals for prescription drugs. This report provides a summary of the consultation results.

An earlier external consultation was held in 2016 about health product transparency initiatives. The purpose of this report is to provide a summary of the results of the on-line questionnaire.

Other lists of submissions under review

The Submissions Under Review (SUR) Lists include new drug submissions and supplemental new drug submissions for new uses. Click here for details and to access the Drug and health products submissions under review lists.

View the list

You can view the generic submissions under review list any time.

Generic submissions currently under review: Abbreviated new drug submissions
Medicinal Ingredient(s) Therapeutic Area Number of submissions under review
Amoxicillin trihydrate Antibacterials for systemic use 1
Apixaban Antithrombotic agents 2
Arsenic trioxide Antineoplastic agents 1
Bendamustine hydrochloride Antineoplastic agents 4
Bortezomib Antineoplastic agents 1
Budesonide Drugs for obstructive airway diseases 1
Bupivacaine hydrochloride Anesthetics 1
Calcitriol Vitamins 1
Carbidopa, entacapone, levodopa Anti-parkinson drugs 1
Cefazolin sodium Antibacterials for systemic use 1
Ceftriaxone sodium Antibacterials for systemic use 1
Cephalexin monohydrate Antibacterials for systemic use 1
Cetirizine hydrochloride Antihistamines for systemic use 1
Cholestyramine resin Lipid modifying agents 1
Cyproterone acetate, ethinyl estradiol Sex hormones and modulators of the genital system 1
Dabigatran etexilate Antithrombotic agents 1
Daptomycin Antibacterials for systemic use 1
Deferasirox All other therapeutic products 1
Desvenlafaxine succinate Psychoanaleptics 1
Dexmedetomidine hydrochloride Psycholeptics 1
Digoxin Cardiac therapy 1
Duloxetine hydrochloride Psychoanaleptics 1
Efavirenz, emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 2
Ertapenem sodium Antibacterials for systemic use 2
Everolimus Antineoplastic agents 2
Ezetimibe Lipid modifying agents 1
Fampridine Other nervous system drugs 1
Fingolimod hydrochloride Immunosuppressants 2
Fluticasone propionate, salmeterol xinafoate Drugs for obstructive airway diseases 1
Furosemide Diuretics 1
Gefitinib Antineoplastic agents 1
Hydroxychloroquine sulfate Antiprotozoals 1
Imatinib mesylate Antineoplastic agents 1
Lacosamide Antiepileptics 3
Lamivudine, zidovudine Antivirals for systemic use 1
Lenalidomide Immunosuppressants 3
Liothyronine sodium Thyroid therapy 1
Melphalan hydrochloride Antineoplastic agents 1
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Mitomycin Antineoplastic agents 1
Nadolol Beta blocking agents 1
Olanzapine Psycholeptics 1
Ondansetron Antiemetics and antinauseants 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 1
Oseltamivir phosphate Antivirals for systemic use 4
Pirfenidone Immunosuppressants 2
Plerixafor Immunosuppressants 1
Pyridostigmine bromide Other nervous system drugs 1
Rasagiline mesylate Anti-parkinson drugs 1
Ritonavir Antivirals for systemic use 1
Rivaroxaban Antithrombotic agents 1
Rosuvastatin calcium Lipid modifying agents 1
Tacrolimus Immunosuppressants 1
Thiamazole Thyroid therapy 1
Tolterodine tartrate Urologicals 1
Trandolapril Agents acting on the renin-angiotensin system 1
Trospium chloride Urologicals 1
Vancomycin hydrochloride Antibacterials for systemic use 1

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