Drug and health product submissions under review (SUR)

How to access lists of drug submissions currently under review, and lists of certain drug submissions formerly under review.

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About the Submissions Under Review (SUR) Lists

The Submissions Under Review (SUR) Lists help to make our review processes more transparent. The lists will help Canadians:

  • make better decisions about their health
  • identify substances accepted for review in Canada

The lists have been implemented in phases.

The Submissions Under Review (SUR) Lists include new drug submissions containing new active substances (pharmaceuticals and biologics with an active ingredient not approved in Canada). This applies to submissions whose review started on or after April 1, 2015.

The lists also include submissions accepted for review on or after May 1, 2016, specifically:

  • new drug submissions
  • supplemental new drug submissions for new uses

Finding information on the lists

There are four Submissions Under Review (SUR) Lists, which contain:

  • new drug submissions currently under review
  • supplemental new drug submissions currently under review
  • new drug submissions formerly under review
  • supplemental new drug submissions formerly under review

All four lists are updated monthly.

The entry for each submission includes the:

Each entry for the submissions formerly under review also includes the:

  • month and year the submission concluded
  • hyperlink to the regulatory decision summary or summary of cancellation

Decisions

A substance is removed from the submissions currently under review list and added to the submissions formerly under review list when:

  • the submission is cancelled or
  • a final decision is made and the submission is no longer under review

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

Information about decisions (positive or negative) and cancellations can be found in the Regulatory Decision Summary. If applicable, a more detailed explanation is available in a Summary Basis of Decision document.

External Consultation Report 2016

The purpose of this report is to provide a summary of the results of the on-line questionnaire. The subject of the questionnaire was health product transparency initiatives.

View the lists

You can view the drug and health product submission lists any time. The four lists are:

Submissions currently under review: New drug submissions
Medicinal Ingredient(s) Therapeutic Area Month, Year Added to the List
Adalimumab Immunosuppressants April 2017
Adalimumab Immunosuppressants April 2017
Anthrax immunoglobulin (human) Immune sera and immunoglobulins January 2017
Avelumab Antineoplastic agents April 2017
Baricitinib Antiinflammatory and antirheumatic products May 2016
Benralizumab Immunosuppressants April 2017
Bevacizumab Antineoplastic agents February 2017
Brodalumab Immunosuppressants July 2016
Buprenorphine hydrochloride Other nervous system drugs September 2016
Bupropion hydrochloride, naltrexone hydrochloride Antiobesity preparations, excluding diet products April 2017
C1 esterase inhibitor (human) Immunosuppressants November 2016
Cefixime Antibacterials for systemic use September 2016
Cidofovir Antivirals for systemic use April 2017
Cinnarizine, dimenhydrinate Other nervous system drugs September 2016
Cladribine Immunosuppressants February 2017
Cyclosporin Ophthalmologicals September 2016
Defibrotide Antithrombotic agents January 2017
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens July 2016
Desvenlafaxine Psychoanaleptics February 2017
Dupilumab Immunosuppressants February 2017
Durvalumab Antineoplastic agents March 2017
Ferric derisomaltose Antianemic preparations July 2016
Fibrinogen (human) Antihemorrhagics August 2016
Flibanserin Other gynecologicals April 2016
Fluocinolone acetonide Ophthalmologicals February 2017
Fluoxetine hydrochloride Psychoanaleptics December 2016
Fluticasone propionate Drugs for obstructive airway diseases November 2016
Fluticasone proprionate, salmeterol xinafoate Drugs for obstructive airway diseases December 2016
Follitropin delta Sex hormones and modulators of the genital system July 2016
Formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases February 2017
Glecaprevir, pibrentasvir Antivirals for systemic use February 2017
Glycopyrrolate Drugs for functional gastrointestinal disorders January 2017
Guselkumab Immunosuppressants January 2017
Human insulin (recombinant) Drugs used in diabetes October 2016
Immune globulin (human) Immune sera and immunoglobulins November 2016
Immunoglobulin G (human) Immune sera and immunoglobulins April 2017
Influenza virus vaccine Vaccines April 2017
Insulin degludec Drugs used in diabetes November 2016
Insulin glargine Drugs used in diabetes April 2017
Insulin lispro Drugs used in diabetes January 2017
Iodine Contrast media September 2016
Ioflupane (123I) Diagnostic radiopharmaceuticals February 2017
Iron dextran Antianemic preparations May 2016
Lifitegrast Ophthalmologicals December 2016
Lixisenatide Drugs used in diabetes June 2016
Lorcaserin hydrochloride Antiobesity preparations, excluding diet products December 2016
Mercaptamine bitartrate Other alimentary tract and metabolism products March 2016
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents September 2016
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents February 2017
Midostaurin Antineoplastic agents January 2017
Migalastat hydrochloride Other alimentary tract and metabolism products November 2016
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines July 2016
Netupitant, palonosetron hydrochloride Antiemetics and antinauseants December 2016
Nonacog beta pegol Antihemorrhagics February 2017
Nusinersen Other nervous system drugs December 2016
Obeticholic acid Bile and liver therapy October 2016
Ocrelizumab Immunosuppressants October 2016
Ocrelizumab Immunosuppressants October 2016
Olaratumab Antineoplastic agents April 2017
Oxycodone Analgesics November 2016
Ozenoxacin Antibiotics and chemotherapy for dermatological use July 2016
Pegfilgrastim Immunostimulants February 2017
Prasterone Anabolic agents for systemic use December 2016
Romosozumab Drugs for treatment of bone diseases October 2016
Salbutamol sulfate Drugs for obstructive airway diseases November 2016
Sebelipase alfa Other alimentary tract and metabolism products April 2017
Semaglutide Drugs used in diabetes March 2017
Sofosbuvir, velpatasvir, voxilaprevir Antivirals for systemic use February 2017
Sucroferric oxyhydroxide All other therapeutic products February 2017
Suvorexant Psycholeptics September 2016
Tenofovir alafenamide hemifumarate Antivirals for systemic use July 2016
Triamcinolone hexacetonide Corticosteroids for systemic use February 2017
Varicella-zoster virus glycoprotein E (GE) Vaccines December 2016
Von Willebrand factor (human) Antihemorrhagics July 2016
 
Submissions currently under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Month, Year Added to the List
Abobotulinumtoxina Muscle relaxants March 2017
Adalimumab Immunosuppressants September 2016
Adalimumab Immunosuppressants February 2017
Anakinra Immunosuppressants July 2016
Apixaban Antithrombotic agents November 2016
Aripiprazole Psycholeptics January 2017
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide
hemifumarate		 Antivirals for systemic use August 2016
Collagenase clostridium histolyticum Other drugs for disorders of the musculo-skeletal system March 2017
Crizotinib Antineoplastic agents November 2016
Dabrafenib Antineoplastic agents November 2016
Denosumab Drugs for treatment of bone diseases April 2017
Dulaglutide Drugs used in diabetes March 2017
Eltrombopag olamine Antihemorrhagics July 2016
Empagliflozin Drugs used in diabetes May 2016
Eptacog alfa Antihemorrhagics January 2017
Eribulin mesylate Antineoplastic agents October 2016
Everolimus Antineoplastic agents February 2017
Fulvestrant Endocrine therapy January 2017
Glycopyrronium bromide, indacaterol maleate Drugs for obstructive airway diseases November 2016
Golimumab Immunosuppressants September 2016
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines November 2016
Idelalisib Antineoplastic agents April 2017
Immune globulin (human) Immune sera and immunoglobulins January 2017
Lanreotide acetate Pituitary and hypothalamic hormones and analogues April 2017
Ledipasvir, sofosbuvir Antivirals for systemic use December 2016
Lenvatinib mesylate Antineoplastic agents November 2016
Linagliptin Drugs used in diabetes June 2016
Linagliptin, metformin hydrochloride Drugs used in diabetes June 2016
Liraglutide Drugs used in diabetes August 2016
Lurasidone hydrochloride Psycholeptics September 2016
Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid Vaccines April 2017
Mifepristone, misoprostol Sex hormones and modulators of the genital system January 2017
Nadroparin calcium Antithrombotic agents August 2016
Nivolumab Antineoplastic agents November 2016
Nivolumab Antineoplastic agents March 2017
Nivolumab Antineoplastic agents April 2017
Ombitasvir, paritaprevir, ritonavir Antivirals for systemic use July 2016
Palbociclib Antineoplastic agents August 2016
Pembrolizumab Antineoplastic agents January 2017
Pembrolizumab Antineoplastic agents March 2017
Ranibizumab Ophthalmologicals January 2017
Regorafenib Antineoplastic agents April 2017
Simeprevir Antivirals for systemic use October 2016
Sofosbuvir, velpatasvir Antivirals for systemic use December 2016
Thioguanine Antineoplastic agents December 2016
Tinzaparin sodium Antithrombotic agents December 2016
Trametinib Antineoplastic agents November 2016
Submissions formerly under review: New drug submissions
Medicinal Ingredient(s) Therapeutic Area Month, Year Submission was Accepted into Review Month, Year Submission Concluded Outcome of Submission
Alectinib Antineoplastic agents February 2016 September 2016 Issued Notice of Compliance under the NOC/c Guidance
Alirocumab Lipid modifying agents June 2015 April 2016 Issued Notice of Compliance
Alvimopan Drugs for constipation March 2016 March 2017 Cancelled by sponsor
Antihemophilic factor (recombinant), pegylated Antihemorrhagics January 2016 November 2016 Issued Notice of Compliance
Ataluren All other therapeutic products September 2015 March 2016 Cancelled by sponsor
Atezolizumab Antineoplastic agents August 2016 April 2017 Issued Notice of Compliance under the NOC/c Guidance
Bepotastine besilate Ophthalmologicals October 2015 July 2016 Issued Notice of Compliance
Bilastine Antihistamines for systemic use June 2015 April 2016 Issued Notice of Compliance
Blinatumomab Antineoplastic agents April 2015 December 2015 Issued Notice of Compliance under the NOC/c Guidance
Botulinum antitoxin, serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins February 2016 December 2016 Issued Notice of Compliance
Brexpiprazole Psycholeptics April 2016 February 2017 Issued Notice of Compliance
Brivaracetam Antiepileptics May 2015 March 2016 Issued Notice of Compliance
Carfilzomib Antineoplastic agents July 2015 January 2016 Issued Notice of Compliance
Clozapine Psycholeptics May 2016 November 2016 Issued Notice of Compliance
Cobimetinib Antineoplastic agents April 2015 February 2016 Issued Notice of Compliance
Daclizumab Immunosuppressants February 2016 December 2016 Issued Notice of Compliance
Daratumumab Antineoplastic agents November 2015 June 2016 Issued Notice of Compliance under the NOC/c Guidance
Edoxaban Antithrombotic agents December 2015 November 2016 Issued Notice of Compliance
Elbasvir, grazoprevir Antivirals for systemic use July 2015 January 2016 Issued Notice of Compliance
Eliglustat tartrate Other alimentary tract and metabolism  products May 2015 April 2017 Issued Notice of Compliance
Elotuzumab Antineoplastic agents December 2015 June 2016 Issued Notice of Compliance
Eluxadoline Drugs for functional gastrointestinal disorders April 2016 January 2017 Issued Notice of Compliance
Etanercept Immunosuppressants June 2016 April 2017 Issued Notice of Compliance
Florbetaben (18F) Diagnostic radiopharmaceuticals April 2016 February 2017 Issued Notice of Compliance
Gadoteric acid Contrast media December 2015 November 2016 Issued Notice of Compliance
Idarucizumab All other therapeutic products May 2015 April 2016 Issued Notice of Compliance under the NOC/c Guidance
Ixazomib citrate Antineoplastic agents February 2016 August 2016 Issued Notice of Compliance
Ixekizumab Immunosuppressants July 2015 May 2016 Issued Notice of Compliance
Lonoctocog alfa Antihemorrhagics February 2016 December 2016 Issued Notice of Compliance
Naloxone hydrochloride All other therapeutic products April 2016 October 2016 Issued Notice of Compliance
Necitumumab Antineoplastic agents May 2016 March 2017 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products March 2016 September 2016 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products May 2016 November 2016 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products July 2016 December 2016 Issued Notice of Compliance
Olaparib Antineoplastic agents June 2015 April 2016 Issued Notice of Compliance under the NOC/c Guidance
Osimertinib Antineoplastic agents November 2015 July 2016 Issued Notice of Compliance under the NOC/c Guidance
Panobinostat Antineoplastic agents November 2015 June 2016 Cancelled by sponsor
Pegaspargase Antineoplastic agents May 2016 February 2017 Issued Notice of Compliance
Peramivir Antivirals for systemic use March 2016 January 2017 Issued Notice of Compliance
Propiverine hydrochloride Urologicals March 2016 January 2017 Issued Notice of Compliance
Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) Antihemorrhagics April 2015 January 2016 Issued Notice of Compliance
Reslizumab Immunosuppressants September 2015 July 2016 Issued Notice of Compliance
Rupatadine fumarate Antihistamines for systemic use September 2015 July 2016 Issued Notice of Compliance
Sarilumab Immunosuppressants March 2016 January 2017 Issued Notice of Compliance
Sofosbuvir, velpatasvir Antivirals for systemic use January 2016 July 2016 Issued Notice of Compliance
Sugammadex All other therapeutic products April 2015 February 2016 Issued Notice of Compliance
Venetoclax Antineoplastic agents February 2016 September 2016 Issued Notice of Compliance under the NOC/c Guidance
Vernakalant hydrochloride Cardiac therapy May 2016 March 2017 Issued Notice of Compliance
Submissions formerly under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Month, Year Submission was Accepted into Review Month, Year Submission Concluded Outcome of Submission
Blinatumomab Antineoplastic agents September 2016 April 2017 Issued Notice of Compliance under the NOC/c Guidance
C1 esterase inhibitor (human) Other hematological agents September 2016 March 2017 Issued Notice of Compliance
Canagliflozin Drugs used in diabetes June 2016 April 2017 Issued Notice of Compliance
Canakinumab Immunosuppressants July 2016 January 2017 Issued Notice of Compliance
Daratumumab Antineoplastic agents October 2016 April 2017 Issued Notice of Compliance
Erlotinib hydrochloride Antineoplastic agents June 2016 March 2017 Issued Notice of Compliance
Etanercept Immunosuppressants May 2016 March 2017 Issued Notice of Compliance
Ipilimumab Antineoplastic agents February 2017 April 2017 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products October 2016 April 2017 Issued Notice of Compliance
Lacosamide Antiepileptics May 2016 February 2017 Issued Notice of Compliance
Leuprolide acetate Endocrine therapy May 2016 February 2017 Issued Notice of Compliance
Omalizumab Drugs for obstructive airway diseases June 2016 April 2017 Issued Notice of Compliance
Panitumumab Antineoplastic agents June 2016 April 2017 Issued Notice of Compliance
Rufinamide Antiepileptics June 2016 April 2017 Issued Notice of Compliance

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