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
Abiraterone acetate Endocrine therapy 2
Acyclovir Antibiotics and chemotherapy for dermatological use 1
Amoxicillin trihydrate Antibacterials for systemic use 1
Apixaban Antithrombotic agents 2
Arsenic trioxide Antineoplastic agents 1
Azacitidine Antineoplastic agents 2
Bendamustine hydrochloride Antineoplastic agents 4
Betamethasone dipropionate, clotrimazole Antifungals for dermatological use 1
Bortezomib Antineoplastic agents 2
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 1
Budesonide Drugs for obstructive airway diseases 1
Bupivacaine hydrochloride Anesthetics 1
Cabazitaxel Antineoplastic agents 2
Calcitriol Vitamins 1
Calcium polystyrene sulphonate All other therapeutic products 1
Carbidopa, entacapone, levodopa Anti-parkinson drugs 1
Caspofungin acetate Antimycotics for systemic use 1
Cefazolin sodium Antibacterials for systemic use 1
Cefepime hydrochloride Antibacterials for systemic use 1
Ceftriaxone sodium Antibacterials for systemic use 1
Celecoxib Antiinflammatory and antirheumatic products 1
Cephalexin monohydrate Antibacterials for systemic use 2
Cetirizine hydrochloride Antihistamines for systemic use 1
Cholestyramine resin Lipid modifying agents 1
Cladribine Antineoplastic agents 1
Clomiphene citrate Sex hormones and modulators of the genital system 1
Colesevelam hydrochloride Lipid modifying agents 1
Cyclosporine Ophthalmologicals 3
Dabigatran etexilate Antithrombotic agents 1
Daptomycin Antibacterials for systemic use 1
Darifenacin hydrobromide Urologicals 1
Darunavir Antivirals for systemic use 1
Dasatinib Antineoplastic agents 2
Deferasirox All other therapeutic products 2
Desvenlafaxine succinate Psychoanaleptics 1
Dexmedetomidine hydrochloride Psycholeptics 1
Dienogest Sex hormones and modulators of the genital system 1
Digoxin Cardiac therapy 1
Dimethyl fumarate Immunosuppressants 3
Diphenhydramine hydrochloride, ibuprofen Antiinflammatory and antirheumatic products 1
Doxorubicin hydrochloride Antineoplastic agents 1
Doxycycline Antibacterials for systemic use 1
Duloxetine hydrochloride Psychoanaleptics 1
Efavrienz, emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Eletriptan hydrobromide Analgesics 1
Emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Enzalutamide Endocrine therapy 1
Ertapenem sodium Antibacterials for systemic use 2
Everolimus Antineoplastic agents 2
Exametazime Diagnostic radiopharmaceuticals 1
Ezetimibe Lipid modifying agents 1
Fampridine Other nervous system drugs 1
Felodipine Calcium channel blockers 1
Fentanyl citrate Analgesics 1
Fentanyl citrate Anesthetics 1
Fesoterodine fumarate Urologicals 1
Fingolimod hydrochloride Immunosuppressants 1
Flecainide acetate Cardiac therapy 1
Fluoxetine hydrochloride Psychoanaleptics 1
Fluticasone propionate, salmeterol xinafoate Drugs for obstructive airway diseases 1
Frovatriptan succinate Analgesics 1
Fusidic acid Antibiotics and chemotherapy for dermatological use 1
Hydralazine hydrochloride Antihypertensives 1
Ibuprofen, pseudoephedrine Antiinflammatory and antirheumatic products 1
Imatinib mesylate Antineoplastic agents 1
Indomethacin Antiinflammatory and antirheumatic products 1
Irinotecan hydrochloride trihydrate Antineoplastic agents 1
Itraconazole Antimycotics for systemic use 1
Lamivudine, zidovudine Antivirals for systemic use 1
Lenalidomide Immunosuppressants 4
Levocarnitine Other alimentary tract and metabolism products 1
Levofloxacin hemihydrate Antibacterials for systemic use 1
Liothyronine sodium Thyroid therapy 1
Melphalan hydrochloride Antineoplastic agents 1
Melphalan hydrochloride, buffer solution Antineoplastic agents 1
Metformin hydrochloride Drugs used in diabetes 1
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Mitomycin Antineoplastic agents 1
Nadolol Beta blocking agents 1
Nebivolol hydrochloride Beta blocking agents 1
Nifedipine Calcium channel blockers 1
Nitrofurantoin Antibacterials for systemic use 1
Octreotide acetate Pituitary and hypothalamic hormones and analogues 2
Olmesartan medoxomil Agents acting on the renin-angiotensin system 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 1
Orlistat Antiobesity preparations, excluding diet products 1
Oseltamivir phosphate Antivirals for systemic use 4
Perampanel Antiepileptics 1
Pilocarpine hydrochloride Other nervous system drugs 1
Pinaverium bromide Drugs for functional gastrointestinal disorders 1
Pirfenidone Immunosuppressants 2
Plerixafor Immunostimulants 1
Posaconazole Antimycotics for systemic use 1
Pregabalin Antiepileptics 1
Progesterone Sex hormones and modulators of the genital system 1
Prucalopride succinate Drugs for constipation 2
Pyridostigmine bromide Other nervous system drugs 1
Rasagiline mesylate Anti-parkinson drugs 1
Ritonavir Antivirals for systemic use 1
Rivaroxaban Antithrombotic agents 3
Sildenafil citrate Urologicals 1
Sitagliptin phosphate monohydrate Drugs used in diabetes 1
Solifenacin succinate Urologicals 1
Tacrolimus Immunosuppressants 1
Tobramycin sulfate Antibacterials for systemic use 1
Tolterodine tartrate Urologicals 1
Tranexamic acid Antihemorrhagics 1
Trospium chloride Urologicals 1
Ulipristal acetate Sex hormones and modulators of the genital system 1
Valganciclovir hydrochloride Antivirals for systemic use 1
Vancomycin hydrochloride Antibacterials for systemic use 1
Voriconazole Antimycotics for systemic use 1

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