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.

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 6
Acetaminophen Analgesics 1
Afatinib Antineoplastic agents 1
Afatinib dimaleate Antineoplastic agents 3
Alendronate sodium Drugs for treatment of bone diseases 1
Allopurinol Antigout preparations 1
Amikacin sulfate Antibacterials for systemic use 1
Amiodarone hydrochloride Cardiac therapy 1
Amoxicillin trihydrate, clavulanic acid Antibacterials for systemic use 2
Apixaban Antithrombotic agents 3
Arsenic trioxide Antineoplastic agents 1
Atazanavir sulfate Antivirals for systemic use 1
Atomoxetine hydrochloride Psychoanaleptics 1
Atorvastatin Lipid modifying agents 1
Atovaquone Antiprotozoals 1
Azacitidine Antineoplastic agents 3
Bendamustine hydrochloride Antineoplastic agents 4
Betamethasone dipropionate, calcipotriol monohydrate Antipsoriatics 1
Bivalirudin Antithrombotic agents 2
Bortezomib Antineoplastic agents 2
Brimonidine tartrate Ophthalmologicals 1
Bupivacaine hydrochloride Anesthetics 2
Buspirone hydrochloride Psycholeptics 1
Cabazitaxel Antineoplastic agents 1
Calcium polystyrene sulphonate All other therapeutic products 1
Carbidopa, entacapone, levodopa Anti-parkinson drugs 1
Caspofungin acetate Antimycotics for systemic use 2
Ceftriaxone sodium Antibacterials for systemic use 1
Celecoxib Antiinflammatory and antirheumatic products 1
Cholestyramine resin Lipid modifying agents 1
Clobetasol propionate Corticosteroids, dermatological preparations 2
Cyclosporine Ophthalmologicals 1
Cytarabine Antineoplastic agents 1
Daptomycin Antibacterials for systemic use 3
Darifenacin hydrobromide Urologicals 1
Darunavir Antivirals for systemic use 2
Darunavir ethanolate Antivirals for systemic use 1
Dasatinib Antineoplastic agents 2
Daunorubicin hydrochloride Antineoplastic agents 1
Deferasirox All other therapeutic products 5
Desmopressin acetate Pituitary and hypothalamic hormones and analogues 1
Desvenlafaxine succinate Psychoanaleptics 1
Diltiazem hydrochloride Calcium channel blockers 1
Dimethyl fumarate Immunosuppressants 7
Dolutegravir Antivirals for systemic use 1
Doxycycline Antibacterials for systemic use 1
Dronedarone hydrochloride Cardiac therapy 1
Efavrienz, emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Efinaconazole Antifungals for dermatological use 4
Eltrombopag olamine Antihemorrhagics 1
Enzalutamide Endocrine therapy 1
Erlotinib hydrochloride Antineoplastic agents 1
Ertapenem sodium Antibacterials for systemic use 2
Ethinyl estradiol, levonorgestrel Sex hormones and modulators of the genital system 1
Ethinyl estradiol, norgestimate Sex hormones and modulators of the genital system 1
Everolimus Antineoplastic agents 1
Famotidine Drugs for acid related disorders 1
Felodipine Calcium channel blockers 1
Fentanyl citrate Analgesics 1
Fentanyl citrate Anesthetics 1
Fesoterodine fumarate Urologicals 1
Fingolimod hydrochloride Immunosuppressants 2
Fluticasone propionate Drugs for obstructive airway diseases 1
Fusidic acid Antibiotics and chemotherapy for dermatological use 1
Gabapentin Antiepileptics 1
Gefitinib Antineoplastic agents 1
Glycopyrrolate Drugs for functional gastrointestinal disorders 1
Hydroxychloroquine sulfate Antiprotozoals 1
Hyoscine butylbromide Drugs for functional gastrointestinal disorders 1
Irinotecan hydrochloride trihydrate Antineoplastic agents 2
Labetalol hydrochloride Beta blocking agents 2
Lamivudine Antivirals for systemic use 2
Lamivudine, zidovudine Antivirals for systemic use 1
Lenalidomide Immunosuppressants 5
Levetiracetam Antiepileptics 1
Levofloxacin hemihydrate Antibacterials for systemic use 1
Lidocaine hydrochloride Cardiac therapy 1
Linagliptin Drugs used in diabetes 1
Lurasidone hydrochloride Psycholeptics 6
Macitentan Antihypertensives 2
Medroxyprogesterone acetate Sex hormones and modulators of the genital system 1
Melphalan hydrochloride, buffer solution Antineoplastic agents 1
Metformin hydrochloride Drugs used in diabetes 1
Metformin hydrochloride, sitagliptin phosphate monohydrate Drugs used in diabetes 2
Methylprednisolone acetate Corticosteroids for systemic use 1
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Micafungin sodium Antimycotics for systemic use 1
Mirabegron Urologicals 2
Mitomycin Antineoplastic agents 1
Nebivolol hydrochloride Beta blocking agents 2
Nifedipine Calcium channel blockers 1
Octreotide acetate Pituitary and hypothalamic hormones and analogues 2
Olmesartan medoxomil Agents acting on the renin-angiotensin system 1
Ondansetron Antiemetics and antinauseants 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 1
Orlistat Antiobesity preparations, excluding diet products 1
Oseltamivir phosphate Antivirals for systemic use 3
Paliperidone Psycholeptics 1
Paroxetine hydrochloride Psychoanaleptics 1
Pemetrexed disodium hemipentahydrate Antineoplastic agents 2
Pentamidine isetionate Antiprotozoals 1
Perampanel Antiepileptics 1
Pioglitazone hydrochloride Drugs used in diabetes 1
Pirfenidone Immunosuppressants 3
Plerixafor Immunostimulants 1
Pomalidomide Immunosuppressants 2
Posaconazole Antimycotics for systemic use 1
Prasugrel hydrochloride Antithrombotic agents 1
Prucalopride succinate Drugs for constipation 1
Pyridostigmine bromide Other nervous system drugs 1
Ritonavir Antivirals for systemic use 1
Rivaroxaban Antithrombotic agents 6
Rosuvastatin calcium Lipid modifying agents 2
Saxagliptin hydrochloride Drugs used in diabetes 1
Sildenafil citrate Urologicals 1
Silodosin Urologicals 1
Sitagliptin Corticosteroids, dermatological preparations 1
Sitagliptin hydrochloride monohydrate Drugs used in diabetes 1
Sitagliptin malate Drugs used in diabetes 1
Sitagliptin phosphate monohydrate Drugs used in diabetes 1
Sodium nitroprusside Drugs used in diabetes 1
Spironolactone Diuretics 1
Sumatriptan succinate Analgesics 2
Sunitinib Antineoplastic agents 2
Sunitinib malate Antineoplastic agents 1
Tacrolimus Immunosuppressants 1
Tadalafil Urologicals 2
Tamsulosin hydrochloride Urologicals 1
Tenofovir disoproxil fumarate Antivirals for systemic use 1
Teriflunomide Immunosuppressants 9
Ticagrelor Antithrombotic agents 1
Tobramycin sulfate Antibacterials for systemic use 1
Tranexamic acid Antihemorrhagics 1
Treprostinil Antithrombotic agents 1
Trospium chloride Urologicals 1
Ulipristal acetate Sex hormones and modulators of the genital system 3
Valproic acid Antineoplastic agents 1
Vancomycin hydrochloride Antibacterials for systemic use 1

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