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
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 2
Amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate Psychoanaleptics 1
Arsenic trioxide Antineoplastic agents 1
Atazanavir sulfate Antivirals for systemic use 1
Atomoxetine hydrochloride Psychoanaleptics 1
Atovaquone Antiprotozoals 1
Azacitidine Antineoplastic agents 2
Bendamustine hydrochloride Antineoplastic agents 5
Betamethasone dipropionate, calcipotriol monohydrate Antipsoriatics 1
Bivalirudin Antithrombotic agents 2
Brimonidine tartrate Ophthalmologicals 1
Bupivacaine hydrochloride Anesthetics 2
Buprenorphine hydrochloride, naloxone hydrochloride dihydrate Other nervous system drugs 2
Buspirone hydrochloride Psycholeptics 2
Busulfan Antineoplastic agents 2
Canagliflozin Drugs used in diabetes 2
Carbidopa, entacapone, levodopa Anti-parkinson drugs 1
Caspofungin acetate Antimycotics for systemic use 2
Clobetasol propionate Corticosteroids, dermatological preparations 2
Clonidine hydrochloride Antihypertensives 1
Cyclosporine Ophthalmologicals 1
Cytarabine Antineoplastic agents 1
Daptomycin Antibacterials for systemic use 3
Darifenacin hydrobromide Urologicals 1
Darunavir ethanolate Antivirals for systemic use 1
Dasatinib Antineoplastic agents 2
Deferasirox All other therapeutic products 5
Desmopressin acetate Pituitary and hypothalamic hormones and analogues 1
Desvenlafaxine succinate Psychoanaleptics 1
Dexmedetomidine hydrochloride Psycholeptics 1
Diltiazem hydrochloride Calcium channel blockers 1
Dimethyl fumarate Immunosuppressants 7
Dipyridamole Antithrombotic agents 1
Dolutegravir Antivirals for systemic use 1
Domperidone Drugs for functional gastrointestinal disorders 1
Domperidone maleate Drugs for functional gastrointestinal disorders 1
Dorzolamide hydrochloride, timolol maleate Ophthalmologicals 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
Emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Enzalutamide Endocrine therapy 1
Ertapenem sodium Antibacterials for systemic use 1
Escitalopram oxalate Psychoanaleptics 1
Ethinyl estradiol, levonorgestrel Sex hormones and modulators of the genital system 1
Ethinyl estradiol, norgestimate Sex hormones and modulators of the genital system 1
Famotidine Drugs for acid related disorders 1
Felodipine Calcium channel blockers 2
Fentanyl citrate Analgesics 1
Fesoterodine fumarate Urologicals 1
Fingolimod hydrochloride Immunosuppressants 1
Fluticasone propionate Drugs for obstructive airway diseases 1
Frovatriptan succinate Analgesics 1
Fulvestrant Endocrine therapy 2
Furosemide Diuretics 2
Fusidic acid Antibiotics and chemotherapy for dermatological use 1
Gabapentin Antiepileptics 1
Glycopyrrolate Drugs for functional gastrointestinal disorders 2
Hydroxychloroquine sulfate Antiprotozoals 2
Hyoscine butylbromide Drugs for functional gastrointestinal disorders 2
Icatibant acetate Other hematological agents 2
Ketorolac tromethamine Antiinflammatory and antirheumatic products 2
Lamivudine Antivirals for systemic use 2
Lenalidomide Immunosuppressants 6
Lenalidomide hydrochloride Immunosuppressants 1
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 3
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 malate Drugs used in diabetes 1
Metformin hydrochloride, sitagliptin phosphate monohydrate Drugs used in diabetes 2
Methotrexate Antineoplastic agents 1
Methylprednisolone acetate Corticosteroids for systemic use 1
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Micafungin sodium Antimycotics for systemic use 1
Midodrine hydrochloride Cardiac therapy 1
Milrinone Cardiac therapy 1
Mirabegron Urologicals 2
Mitomycin Antineoplastic agents 1
Mometasone furoate Corticosteroids, dermatological preparations 1
Mycophenolate sodium Immunosuppressants 1
Naloxone hydrochloride All other therapeutic products 1
Nebivolol hydrochloride Beta blocking agents 2
Nifedipine Calcium channel blockers 1
Octreotide acetate Pituitary and hypothalamic hormones and analogues 1
Olopatadine hydrochloride Ophthalmologicals 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 2
Paliperidone Psycholeptics 2
Paliperidone palmitate Psycholeptics 1
Paroxetine hydrochloride Psychoanaleptics 1
Pemetrexed disodium hemipentahydrate Antineoplastic agents 2
Pentamidine isetionate Antiprotozoals 1
Perampanel Antiepileptics 1
Pilocarpine hydrochloride Other nervous system drugs 1
Pioglitazone hydrochloride Drugs used in diabetes 1
Pirfenidone Immunosuppressants 4
Plerixafor Immunostimulants 1
Pomalidomide Immunosuppressants 2
Posaconazole Antimycotics for systemic use 1
Pyridostigmine bromide Other nervous system drugs 1
Ritonavir Antivirals for systemic use 1
Rivaroxaban Antithrombotic agents 6
Rosuvastatin calcium Lipid modifying agents 1
Saxagliptin hydrochloride Drugs used in diabetes 1
Sildenafil citrate Urologicals 1
Silodosin Urologicals 1
Sitagliptin Drugs used in diabetes 1
Sitagliptin hydrochloride monohydrate Drugs used in diabetes 1
Sitagliptin malate Drugs used in diabetes 1
Sitagliptin phosphate Drugs used in diabetes 1
Sitagliptin phosphate monohydrate Drugs used in diabetes 1
Sodium nitroprusside Drugs used in diabetes 1
Sodium pyrophosphate Diagnostic radiopharmaceuticals 1
Spironolactone Diuretics 1
Sumatriptan succinate Analgesics 2
Sunitinib Antineoplastic agents 2
Sunitinib malate Antineoplastic agents 2
Tacrolimus Immunosuppressants 1
Tadalafil Urologicals 3
Tamsulosin hydrochloride Urologicals 1
Tenofovir disoproxil fumarate Antivirals for systemic use 1
Teriflunomide Immunosuppressants 9
Ticagrelor Antithrombotic agents 1
Tofacitinib Immunosuppressants 1
Tofacitinib citrate Immunosuppressants 2
Treprostinil Antithrombotic agents 2
Tretinoin Antineoplastic agents 1
Trospium chloride Urologicals 1
Ulipristal acetate Sex hormones and modulators of the genital system 3
Valproic acid Antineoplastic agents 1
Valsartan Agents acting on the renin-angiotensin system 1

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