Generic submissions under review
How to access a list of generic drug submissions currently under review.
On this page
- About the Generic Submissions Under Review (GSUR) List
- Finding information on the list
- Other lists of submissions under review
- View the list
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:
- medicinal ingredient(s)
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
- number of ANDSs under review with Health Canada that month
The list is updated monthly.
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.
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.
|Medicinal Ingredient(s)||Therapeutic Area||Number of submissions under review|
|Abiraterone acetate||Endocrine therapy||2|
|Amoxicillin trihydrate||Antibacterials for systemic use||1|
|Arsenic trioxide||Antineoplastic agents||1|
|Bendamustine hydrochloride||Antineoplastic agents||4|
|Budesonide||Antidiarrheals, intestinal anti-inflammatory/anti-infective agents||1|
|Budesonide||Drugs for obstructive airway diseases||1|
|Calcium polystyrene sulphonate||All other therapeutic products||1|
|Carbidopa, entacapone, levodopa||Anti-parkinson drugs||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|
|Clomiphene citrate||Sex hormones and modulators of the genital system||1|
|Colesevelam hydrochloride||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||2|
|Dienogest||Sex hormones and modulators of the genital system||1|
|Diphenhydramine hydrochloride, ibuprofen||Antiinflammatory and antirheumatic products||1|
|Doxorubicin hydrochloride||Antineoplastic agents||1|
|Doxycycline||Antibacterials for systemic use||1|
|Emtricitabine, tenofovir disoproxil fumarate||Antivirals for systemic use||1|
|Ertapenem sodium||Antibacterials for systemic use||2|
|Ezetimibe||Lipid modifying agents||1|
|Fampridine||Other nervous system drugs||1|
|Felodipine||Calcium channel blockers||1|
|Flecainide acetate||Cardiac therapy||1|
|Fluticasone propionate, salmeterol xinafoate||Drugs for obstructive airway diseases||1|
|Imatinib mesylate||Antineoplastic agents||2|
|Indomethacin||Antiinflammatory and antirheumatic products||1|
|Irinotecan hydrochloride trihydrate||Antineoplastic agents||1|
|Lamivudine, zidovudine||Antivirals for systemic use||1|
|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|
|Metformin hydrochloride||Drugs used in diabetes||1|
|Nadolol||Beta blocking agents||1|
|Nebivolol hydrochloride||Beta blocking agents||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||2|
|Orlistat||Antiobesity preparations, excluding diet products||1|
|Oseltamivir phosphate||Antivirals for systemic use||4|
|Pinaverium bromide||Drugs for functional gastrointestinal disorders||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|
|Sitagliptin phosphate monohydrate||Drugs used in diabetes||1|
|Vancomycin hydrochloride||Antibacterials for systemic use||1|
|Voriconazole||Antimycotics for systemic use||1|
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