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.

On this page

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. You can find more information about the phased approach in the Notices published in April 2016 (Phase I and II) and August 2018 (Phase III).

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 accepted for review 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

A separate list is published for generic submissions (abbreviated new drug submissions) accepted into review on or after October 1, 2018. Click here to see the Generic Submissions Under Review (GSUR) List.

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. A substance is moved from the list of submissions currently under review to the list of submissions formerly under review when it reaches a conclusion (it is cancelled, or a final decision is made).

Lists of submissions currently under review

The entry for each submission on the lists of submissions currently under review includes the:

For submissions accepted into review on or after October 1, 2018, the following information will be added to the lists of submissions currently under review:

  • company name
  • ‘class’ of the submission

The submission ‘class’ includes whether the submission is for a new active substance or a biosimilar, if it is being reviewed as per a formal expedited process, if review is taking place as part of an aligned process with a health technology assessment organization, and more. More information can be found here.

Lists of submissions formerly under review

Each entry for each submission on the lists of submissions formerly under review includes the:

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 Consultations

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.

The purpose of this report is to provide a summary of the results of the on-line questionnaire posted in 2016. 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 Submission was Accepted into Review Company Name
(available for submissions accepted into review on or after October 1, 2018)
Submission ‘Class’
(if applicable)
(available for submissions accepted into review on or after October 1, 2018)
Adalimumab Immunosuppressants November 2018 Sandoz Canada Incorporated Biosimilar
Alpelisib Antineoplastic agents May 2019 Novartis Pharmaceuticals Canada Inc New active substance
Amoxicillin sodium, clavulanic acid Antibacterials for systemic use April 2019 Sandoz Canada Incorporated Being reviewed under the Submissions Relying on Third-Party Data Guidance
Apomorphine hydrochloride Anti-parkinson drugs August 2018 Not available Not available
Ataluren Other drugs for disorders of the musculo-skeletal system September 2018 Not available Not available
Avanafil Urologicals June 2019 Acerus Pharmaceuticals Corporation New active substance
Bacillus Calmette-Guerin BCG Immunostimulants December 2018 Verity Pharmaceuticals Inc Not applicable
Baloxavir marboxil Antivirals for systemic use May 2019 Hoffmann La Roche Limited New active substance
Belinostat Antineoplastic agents December 2017 Not available Not available
Betula Verrucosa Extract Nasal preparations June 2019 ALK – Abello A/S Not applicable
Bevacizumab Antineoplastic agents August 2018 Not available Not available
Bisoprolol fumarate Beta blocking agents July 2017 Not available Not available
Brolucizumab Ophthalmologicals May 2019 Novartis Pharmaceuticals Canada Inc New active substance
Part of ‘aligned review’ with a health technology assessment organization
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents May 2019 Avir Pharma Inc Being reviewed under the Priority Review Policy
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents June 2019 Bausch Health, Canada Inc. Not applicable
Cabotegravir, rilpivirine Antivirals for systemic use May 2019 ViiV Healthcare ULC

New active substance

Part of ‘aligned review’ with a health technology assessment organization

Caffeine citrate Psychoanaleptics May 2019 Chiesi Farmaceutici S.p.A. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Caplacizumab Antithrombotic agents August 2019 Sanofi Aventis Canada Inc New active substance
Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride Blood substitutes and perfusion solutions June 2019 Fresenius Kabi Canada Ltd Being reviewed under the Submissions Relying on Third-Party Data Guidance
Darolutamide Endocrine therapy April 2019 Bayer Inc New active substance
Dequalinium chloride Gynecological antiinfectives and antiseptics July 2019 Duchesnay Inc Not applicable
Dermatophagoides farinae, dermatophagoides pteronyssinus Allergens September 2017 Not available Not available
Dexamethasone sodium phosphate, netilmicin sulfate Ophthalmologicals February 2018 Not available Not available
Entrectinib Antineoplastic agents June 2019 Hoffmann La Roche Limited

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance
Entrectinib Antineoplastic agents July 2019 Hoffmann La Roche Limited Not applicable
Erdafitinib Antineoplastic agents March 2019 Janssen Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Part of an 'aligned review' with a health technology assessment (HTA) organization

Esketamine hydrochloride Psychoanaleptics January 2019 Janssen Inc

Being reviewed under the Priority Review Policy

Part of ‘aligned review’ with a health technology assessment organization

Etonogestrel Sex hormones and modulators of the genital system May 2019 Merck Canada Inc Not applicable
Filgrastim (r-metHuG-CSF) Immunostimulants April 2018 Not available Not available
Filgrastim (r-metHuG-CSF) Immunostimulants March 2019 Tanvex Biopharm USA, Inc Biosimilar
Fremanezumab Analgesics June 2019 Teva Canada Limited New active substance
Gallium (68Ga) chloride Diagnostic radiopharmaceuticals April 2019 Ire Elit S.A. New active substance
Ganciclovir Ophthalmologicals February 2019 Laboratoires Thea Not applicable
Gemtuzumab ozogamicin Antineoplastic agents February 2019 Pfizer Canada ULC

New active substance

Part of an 'aligned review' with a health technology assessment (HTA) organization

Gilteritinib fumarate Antineoplastic agents June 2019 Astellas Pharma Canada Inc

New active substance

Being reviewed under the Priority Review Policy
Glasdegib Antineoplastic agents July 2019 Pfizer Canada ULC New active substance
Glucagon Pancreatic hormones November 2018 Eli Lilly Canada Inc Part of 'aligned review' with a health technology assessment organization
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines January 2019 Seqirus UK Limited Not applicable
Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations May 2018 Not available Part of 'aligned review' with a health technology assessment organization
Icosapent ethyl Lipid modifying agents July 2019 HLS Therapeutics Inc New active substance
Being reviewed under the Priority Review Policy
Immunoglobulin (human) Immune sera and immunoglobulins June 2019 Grifols Therapeutics LLC Not applicable
Indacaterol acetate,
mometasone furoate
Drugs for obstructive airway diseases July 2019 Novartis Pharmaceuticals Canada Inc Not applicable
Infliximab Immunosuppressants May 2019 Amgen Canada Inc Biosimilar
Isatuximab Antineoplastic agents July 2019 Sanofi-Aventis Canada Inc New active substance
Magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, sodium citrate dihydrate, sodium phosphate dibasic, sodium phosphate monobasic, water All other non-therapeutic products November 2018 Maco Pharma Not applicable
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents September 2016 Not available Not available
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents February 2017 Not available Not available
Methylene blue Diagnostic agents October 2018 Pendopharm Division of Pharmascience Inc Not applicable
Mometasone furoate Corticosteroids, dermatological preparations September 2017 Not available Not available
Naproxen sodium, sumatriptan succinate Analgesics May 2019 Aralez Pharmaceuticals Canada Inc Not applicable
Nicardipine hydrochloride Calcium channel blockers July 2018 Not available Not available
Ospemifene Sex hormones and modulators of the genital system March 2019 Duchesnay Inc New active substance
Pegfilgrastim Immunostimulants May 2019 Sandoz Canada Incorporated Biosimilar
Plecanatide Drugs for constipation December 2018 Cipher Pharmaceuticals Inc New active substance
Prasterone Anabolic agents for systemic use December 2016 Not available Not available
Rituximab Antineoplastic agents April 2018 Not available Not available
Rituximab Antineoplastic agents March 2019 Pfizer Canada ULC Biosimilar
Semaglutide Drugs used in diabetes June 2019 Novo Nordisk Canada Inc Not applicable
Siponimod fumarate Immunosuppressants February 2019 Novartis Pharmaceuticals Canada Inc New active substance
Part of 'aligned review' with a health technology assessment organization
Sodium chloride, sodium citrate Blood substitutes and perfusion solutions May 2019 Baxter Corporation Being reviewed under the Submissions Relying on Third-Party Data Guidance
Sonidegib Antineoplastic agents August 2019 Sun Pharma Global FZE New active substance
Part of 'aligned review' with a health technology assessment organization
Tafamidis meglumine Other nervous system drugs July 2019 Pfizer Canada ULC New active substance
Being reviewed under the Priority Review Policy
Talazoparib Antineoplastic agents November 2018 Pfizer Canada Inc New active substance
Tenapanor Drugs for constipation June 2019 Knight Therapeutics Inc. New active substance
Teriparatide Calcium homeostasis June 2018 Not available Not available
Tildrakizumab Immunosuppressants February 2019 Sun Pharma Global FZE New active substance
Trastuzumab Antineoplastic agents October 2017 Not available Not available
Trastuzumab
(3 submissions under review)
Antineoplastic agents November 2017 Not available Not available
Trastuzumab Antineoplastic agents February 2018 Not available Not available
Trifarotene Anti-acne preparations January 2019 Galderma Canada Inc New active substance
Upadacitinib Immunosuppressants March 2019 Abbvie Corporation New active substance
Vitamin D3 Vitamins January 2019 Galephar Pharmaceutical Research Inc Not applicable
Vitamin K1 Antihemorrhagics August 2019 Marcan Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Submissions currently under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Month, Year Submission was Accepted into Review Company Name
(available for submissions accepted into review on or after October 1, 2018)
Submission ‘Class’
(if applicable)
(available for submissions accepted into review on or after October 1, 2018)
Adalimumab Immunosuppressants October 2018 Amgen Canada Inc Biosimilar
Alirocumab Lipid modifying agents October 2018 Sanofi-Aventis Canada Inc Not applicable
Apalutamide Endocrine therapy June 2019 Janssen Inc Being reviewed under the Priority Review Policy
Atezolizumab Antineoplastic agents February 2019 Hoffmann La Roche Limited Being reviewed under the Priority Review Policy
Atezolizumab Antineoplastic agents June 2019 Hoffmann La Roche Limited Not applicable
Avelumab Antineoplastic agents April 2019 EMD Serono a Division of EMD Inc Canada Being reviewed under the Notice of Compliance with Conditions Guidance
Avelumab Antineoplastic agents June 2019 EMD Serono a Division of EMD Inc Canada Not applicable
Azelastine hydrochloride, fluticasone propionate Nasal preparations December 2018 BGP Pharma ULC Not applicable
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use May 2019 Gilead Sciences Canada Inc Not applicable
Blinatumomab Antineoplastic agents December 2017 Not available Not available
Brentuximab vedotin Antineoplastic agents July 2018 Not available Not available
Brentuximab vedotin Antineoplastic agents May 2019 Seattle Genetics Inc Being reviewed under the Priority Review Policy
Brivaracetam Antiepileptics May 2019 UCB Canada Inc Not applicable
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents September 2018 Not available Not available
Budesonide, formoterol fumarate dihydrate Drugs for obstructive airway diseases November 2018 AstraZeneca Canada Inc Not applicable
Burosumab Drugs for the treatment of bone diseases August 2019 Kyowa Kirin Limited Not applicable
Cabozantinib Antineoplastic agents December 2018 Ipsen Biopharmaceuticals Canada Inc Not applicable
Cabozantinib Antineoplastic agents January 2019 Ipsen Biopharmaceuticals Canada Inc Part of 'aligned review' with a health technology assessment organization
Canagliflozin Drugs used in diabetes August 2019 Janssen Inc Not applicable
Carbetocin Pituitary and hypothalamic hormones and analogues May 2019 Ferring Inc Not applicable
Carglumic acid Other alimentary tract and metabolism products June 2019 Orphan Europe SARL Being reviewed under the Priority Review Policy
Certolizumab pegol Immunosuppressants January 2019 UCB Canada Inc Not applicable
Dapagliflozin, metformin hydrochloride Drugs used in diabetes July 2019 AstraZeneca Canada Inc Not applicable
Dapagliflozin propanediol Drugs used in diabetes June 2019 AstraZeneca Canada Inc Not applicable
Daratumumab Antineoplastic agents May 2019 Janssen Inc Being reviewed under the Priority Review Policy
Part of an 'aligned review' with a health technology assessment (HTA) organization
Diphtheria toxoid, filamentous hemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid Vaccines November 2018 Sanofi Pasteur Limited Not applicable
Diphtheria toxoid, filamentous hemagglutinin, fimbriae types 2 and 3 (FIM), inactivated poliomyelitis vaccine (D.C.O) type 1 Mahoney, inactivated poliomyelitis vaccine (D.C.O) type 2 M.E.F.1, inactivated poliomyelitis vaccine (D.C.O) type 3 Saukett, pertactin, pertussis toxoid, tetanus toxoid Vaccines November 2018 Sanofi Pasteur Limited Not applicable
Dupilumab Other dermatological preparations November 2018 Sanofi-Aventis Canada Inc Not applicable
Eculizumab Immunosuppressants April 2019 Alexion Pharma GmbH Being reviewed under the Priority Review Policy
Etanercept Immunosuppressants May 2019 Sandoz Canada Incorporated Biosimilar
Fibrinogen (human) Antihemorrhagics June 2019 CSL Behring Canada Inc Not applicable
Flibanserin Other gynecologicals July 2019 Sprout Pharmaceuticals Canada, Ltd Not applicable
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines April 2019 BGP Pharma ULC Not applicable
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines August 2019 Sanofi Pasteur Limited Not applicable
Hydroxyethyl starch
(2 submissions under review)
Blood substitutes and perfusion solutions April 2019 Fresenius Kabi Canada Ltd Not applicable
Hydroxyurea Antineoplastic agents April 2019 Bristol-Myers Squibb Canada Not applicable
Ibrutinib Antineoplastic agents January 2019 Janssen Inc Not applicable
Immunoglobulin (human) Immune sera and immunoglobulins February 2019 Octapharma Pharmazeutika Produktionsges M B H Not applicable
Insulin aspart Drugs used in diabetes May 2019 Novo Nordisk Canada Inc Not applicable
Insulin glargine Drugs used in diabetes July 2019 Sanofi-Aventis Canada Inc Not applicable
Ixekizumab Immunosuppressants April 2019 Eli Lilly Canada Inc Part of aligned review with a health technology assessment organization.
Lenvatinib mesylate Antineoplastic agents July 2019 Eisai Limited Not applicable
Levomilnacipran Psychoanaleptics January 2019 Allergan Inc Not applicable
Linagliptin Drugs used in diabetes January 2019 Boehringer Ingelheim (Canada) Ltd Ltee Not applicable
Liraglutide Drugs used in diabetes May 2019 Novo Nordisk Canada Inc Not applicable
Macitentan Antihypertensives November 2018 Janssen Inc Not applicable
Macitentan Antihypertensives January 2019 Janssen Inc Not applicable
Mepolizumab Drugs for obstructive airway diseases May 2019 GlaxoSmithKline Inc Not applicable
Methylphenidate hydrochloride Psychoanaleptics March 2019 Purdue Pharma Not applicable
Naloxegol oxalate Drugs for constipation November 2018 Knight Therapeutics Inc Not applicable
Nintedanib Antineoplastic agents May 2019 Bohringer Ingelheim (Canada) Ltd Ltee Being reviewed under the Priority Review Policy
Nivolumab Antineoplastic agents June 2018 Not available Not available
Olaparib Antineoplastic agents August 2019 AstraZeneca Canada Inc Being reviewed under the Priority Review Policy
Olodaterol hydrochloride, tiotropium bromide monohydrate Drugs for obstructive airway diseases March 2019 Boehringer Ingelheim (Canada) Ltd Ltee Not applicable
Pembrolizumab Antineoplastic agents September 2018 Not available Not available
Pembrolizumab Antineoplastic agents July 2019 Merck Canada Inc Not applicable
Pembrolizumab Antineoplastic agents February 2019 Merck Canada Inc Not applicable
Perampanel Antiepileptics May 2019 Eisai Limited Not applicable
Pimecrolimus Other dermatological preparations November 2018 Valeant Canada LP Valeant Canada S.E.C. Not applicable
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein Vaccines February 2019 Merck Canada Inc Not applicable
Ribociclib succinate Antineoplastic agents April 2019 Novartis Pharmaceuticals Canada Inc Not applicable
Rituximab Antineoplastic agents July 2019 Celltrion Healthcare Co Ltd Biosimilar
Secukinumab Immunostimulants September 2018 Not available Not available
Semaglutide Drugs used in diabetes June 2019 Novo Nordisk Canada Inc Not applicable
Somatropin R DNA origin Pituitary and hypothalamic hormones and analogues August 2019 Pfizer Canada ULC Not applicable
Teriflunomide Immunosuppressants December 2018 Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc Not applicable
Tipiracil hydrochloride, trifluridine Antineoplastic agents May 2019 Taiho Pharma Canada, Inc. Reviewed under the Priority Review Policy
Trastuzumab emtansine Antineoplastic agents May 2019 Hoffmann La Roche Limited Reviewed under the Priority Review Policy
Part of an 'aligned review' with a health technology assessment (HTA) organization
Umeclidinium bromide Drugs for obstructive airway diseases January 2019 GlaxoSmithKline Inc Not applicable
Ustekinumab Immunosuppressants March 2019 Janssen Inc Not applicable
Ustekinumab Immunosuppressants August 2019 Janssen Inc Not applicable
Venetoclax Antineoplastic agents July 2019 AbbVie Corporation Not applicable
Submissions formerly under review: New drug submissions
Medicinal Ingredient(s) Therapeutic Area Submission Control Number Month, Year Submission was Accepted into Review Month, Year Submission Concluded Outcome of Submission
Abemaciclib Antineoplastic agents 215268 June 2018 April 2019 Issued Notice of Compliance
Acalabrutinib Antineoplastic agents 214504 April 2018 August 2019 Issued Notice of Compliance under the NOC/c Guidance
Acetaminophen Analgesics 209478 February 2018 November 2018 Issued Notice of Compliance
Adalimumab Immunosuppressants 203250 April 2017 May 2018 Issued Notice of Compliance
Adalimumab Immunosuppressants 203292 April 2017 May 2018 Issued Notice of Compliance
Alectinib Antineoplastic agents 189442 February 2016 September 2016 Issued Notice of Compliance under the NOC/c Guidance
Alirocumab Lipid modifying agents 183116 June 2015 April 2016 Issued Notice of Compliance
Alvimopan Drugs for constipation 189825 March 2016 March 2017 Cancelled by sponsor
Amlodipine besylate Calcium channel blockers 211854 July 2018 January 2019 Issued Notice of Compliance
Anthrax antigen filtrate Vaccines 212387 February 2018 December 2018 Issued Notice of Compliance
Anthrax immunoglobulin (human) Immune sera and immunoglobulins 200446 January 2017 November 2017 Issued Notice of Compliance
Antihemophilic factor (human), Von Willebrand factor (human) Antihemorrhagics 194071 June 2017 May 2018 Issued Notice of Compliance
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 189709 January 2016 November 2016 Issued Notice of Compliance
Antihemophilic factor (recombinant, B-domain deleted, pegylated) Antihemorrhagics 210935 December 2017 October 2018 Issued Notice of Compliance
Antihemophilic factor VIII (Recombinant, B domain truncated), pegylated Antihemorrhagics 218531 September 2018 July 2019 Issued Notice of Compliance
Apalutamide Endocrine therapy 211942 January 2018 July 2018 Issued Notice of Compliance
Ataluren Other drugs for disorders of the musculo-skeletal system 186992 September 2015 March 2016 Cancelled by sponsor
Atezolizumab Antineoplastic agents 196843 August 2016 April 2017 Issued Notice of Compliance under the NOC/c Guidance
Avelumab Antineoplastic agents 204052 April 2017 December 2017 Issued Notice of Compliance under the NOC/c Guidance
Avelumab Antineoplastic agents 208742 September 2017 May 2018 Issued Notice of Compliance under the NOC/c Guidance
Axicabtagene ciloleucel Antineoplastic agents 218389 August 2018 February 2019 Issued Notice of Compliance
Baricitinib Antiinflammatory and antirheumatic products 193687 May 2016 August 2018 Issued Notice of Compliance
Benralizumab Immunosuppressants 204008 April 2017 February 2018 Issued Notice of Compliance
Bepotastine besilate Ophthalmologicals 179294 October 2015 July 2016 Issued Notice of Compliance
Betamethasone valerate, fusidic acid Corticosteroids, dermatological preparations 203765 June 2017 April 2018 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 201427 February 2017 April 2018 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 218183 August 2018 June 2019 Issued Notice of Compliance
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 203718 September 2017 July 2018 Issued Notice of Compliance
Bilastine Antihistamines for systemic use 184231 June 2015 April 2016 Issued Notice of Compliance
Blinatumomab Antineoplastic agents 181723 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 190645 February 2016 December 2016 Issued Notice of Compliance
Brexpiprazole Psycholeptics 192684 April 2016 February 2017 Issued Notice of Compliance
Brigatinib Antineoplastic agents 210369 November 2017 July 2018 Issued Notice of Compliance under the NOC/c Guidance
Brivaracetam Antiepileptics 183355 May 2015 March 2016 Issued Notice of Compliance
Brodalumab Immunosuppressants 195317 July 2016 March 2018 Issued Notice of Compliance
Buprenorphine Other nervous system drugs 215660 May 2018 November 2018 Issued Notice of Compliance
Buprenorphine hydrochloride Other nervous system drugs 196428 August 2016 June 2017 Issued Notice of Compliance
Buprenorphine hydrochloride Other nervous system drugs 204746 June 2017 April 2018 Issued Notice of Compliance
Bupropion hydrochloride, naltrexone hydrochloride Antiobesity preparations, excluding diet products 202774 April 2017 February 2018 Issued Notice of Compliance
Burosumab Drugs for treatment of bone diseases 216239 June 2018 December 2018 Issued Notice of Compliance
C1 esterase inhibitor (human) Other hematological agents 198308 November 2016 September 2017 Issued Notice of Compliance
Cabozantinib Antineoplastic agents 206230 July 2017 September 2018 Issued Notice of Compliance
Calcifediol Vitamins 205392 September 2017 July 2018 Issued Notice of Compliance
Canakinumab Immunosuppressants 213303 June 2018 December 2018 Cancelled by sponsor
Carfilzomib Antineoplastic agents 184479 July 2015 January 2016 Issued Notice of Compliance
Cefixime Antibacterials for systemic use 189720 May 2016 October 2017 Issued Notice of Compliance
Cemiplimab Antineoplastic agents 218718 August 2018 April 2019 Issued Notice of Compliance under the NOC/c Guidance
Cenegermin Ophthalmologicals 218145 August 2018 February 2019 Issued Notice of Compliance
Cerliponase alfa Other alimentary tract and metabolism products 216539 June 2018 December 2018 Issued Notice of Compliance
Cidofovir Antivirals for systemic use 200865 April 2017 March 2018 Issued Notice of Compliance
Cinnarizine, dimenhydrinate Other nervous system drugs 195151 September 2016 February 2019 Issued Notice of Non-compliance- Withdrawal
Cladribine Immunosuppressants 200943 February 2017 November 2017 Issued Notice of Compliance
Clozapine Psycholeptics 193638 May 2016 November 2016 Issued Notice of Compliance
Coagulation factor IX (recombinant), pegylated Antihemorrhagics 201114 February 2017 November 2017 Issued Notice of Compliance
Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 199705 May 2017 March 2018 Issued Notice of Compliance
Cobimetinib fumarate Antineoplastic agents 182788 April 2015 February 2016 Issued Notice of Compliance
Crisaborole Other dermatological preparations 206906 August 2017 June 2018 Issued Notice of Compliance
Cyclosporin Ophthalmologicals 194580 August 2016 April 2018 Issued Notice of Non-compliance- Withdrawal
Cyclosporin Ophthalmologicals 215813 July 2018 December 2018 Issued Notice of Compliance
Cysteamine hydrochloride Ophthalmologicals 211635 February 2018 February 2019 Issued Notice of Compliance
Daclizumab Immunosuppressants 190458 February 2016 December 2016 Issued Notice of Compliance
Dacomitinib Antineoplastic agents 214572 May 2018 February 2019 Issued Notice of Compliance
Dalbavancin Antibacterials for systemic use 212390 March 2018 September 2018 Issued Notice of Compliance
Daratumumab Antineoplastic agents 187648 November 2015 June 2016 Issued Notice of Compliance under the NOC/c Guidance
Darvadstrocel Unassigned 217347 August 2018 June 2019 Cancelled by sponsor
Decitabine Antineoplastic agents 207372 March 2018 January 2019 Issued Notice of Compliance
Decitabine Antineoplastic agents 217663 September 2018 July 2019 Issued Notice of Compliance
Defibrotide Antithrombotic agents 200808 January 2017 July 2017 Issued Notice of Compliance
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 195186 July 2016 May 2017 Issued Notice of Compliance
Desvenlafaxine Psychoanaleptics 199626 February 2017 August 2017 Issued Notice of Compliance
Dinutuximab Antineoplastic agents 212066 February 2018 November 2018 Issued Notice of Compliance
Dolutegravir, lamivudine Antivirals for systemic use 220275 October 2018 August 2019 Issued Notice of Compliance
Dolutegravir sodium, rilpivirine hydrochloride Antivirals for systemic use 206402 July 2017 May 2018 Issued Notice of Compliance
Doravirine Antivirals for systemic use 211293 December 2017 December 2017 Issued Notice of Compliance
Doravirine, lamivudine, tenofovir disoproxil fumarate Antivirals for systemic use 211708 January 2018 November 2018 Issued Notice of Compliance
Dotatate Diagnostic radiopharmaceuticals 218346 September 2018 July 2019 Issued Notice of Compliance
Dupilumab Immunosuppressants 201285 February 2017 November 2017 Issued Notice of Compliance
Durvalumab Antineoplastic agents 202953 March 2017 November 2017 Issued Notice of Compliance under the NOC/c Guidance
Durvalumab Antineoplastic agents 208834 September 2017 May 2018 Issued Notice of Compliance under the NOC/c Guidance
Edaravone Other nervous system drugs 214391 April 2018 October 2018 Issued Notice of Compliance
Edoxaban Antithrombotic agents 187363 December 2015 November 2016 Issued Notice of Compliance
Elagolix Sex hormones and modulators of the genital system 209513 December 2017 October 2018 Issued Notice of Compliance
Elbasvir, grazoprevir Antivirals for systemic use 185866 July 2015 January 2016 Issued Notice of Compliance
Eliglustat tartrate Other alimentary tract and metabolism products 183050 May 2015 April 2017 Issued Notice of Compliance
Elotuzumab Antineoplastic agents 188144 December 2015 June 2016 Issued Notice of Compliance
Eluxadoline Drugs for functional gastrointestinal disorders 190162 April 2016 January 2017 Issued Notice of Compliance
Emicizumab Antihemorrhagics 212635 February 2018 August 2018 Issued Notice of Compliance
Enasidenib mesylate Antineoplastic agents 217033 July 2018 February 2019 Issued Notice of Compliance under the NOC/c Guidance
Erenumab Analgesics 208607 October 2017 August 2018 Issued Notice of Compliance
Ertugliflozin pidolate Drugs used in diabetes 204724 July 2017 May 2018 Issued Notice of Compliance
Ertugliflozin pidolate, metformin hydrochloride Drugs used in diabetes 201005 August 2017 May 2018 Issued Notice of Compliance
Ertugliflozin pidolate, sitagliptin phosphate monohydrate Drugs used in diabetes 201006 July 2017 May 2018 Issued Notice of Compliance
Estriol, lactobacillus acidophilus Sex hormones and modulators of the genital system 203472 June 2017 January 2019 Issued a Notice of Deficiency-Withdrawal
Etanercept Immunosuppressants 193864 June 2016 April 2017 Issued Notice of Compliance
Fibrinogen (human) Antihemorrhagics 195870 August 2016 June 2017 Issued Notice of Compliance
Filgrastim (r metHuG CSF) Immunostimulants 212016 February 2018 August 2019 Cancelled by sponsor
Flibanserin Other gynecologicals 189352 April 2016 February 2018 Issued Notice of Compliance
Florbetaben (18F) Diagnostic radiopharmaceuticals 193105 April 2016 February 2017 Issued Notice of Compliance
Fluocinolone acetonide Ophthalmologicals 201510 February 2017 November 2018 Issued Notice of Compliance
Fluorouracil Antineoplastic agents 211768 April 2018 February 2019 Issued Notice of Compliance
Fluoxetine hydrochloride Psychoanaleptics 198520 December 2016 June 2017 Issued Notice of Compliance
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 204880 June 2017 April 2018 Issued Notice of Compliance
Fluticasone propionate Drugs for obstructive airway diseases 197873 October 2016 August 2017 Issued Notice of Compliance
Fluticasone proprionate, salmeterol xinafoate Drugs for obstructive airway diseases 197974 November 2016 April 2018 Issued Notice of Compliance
Follitropin delta Sex hormones and modulators of the genital system 188743 January 2016 March 2018 Issued Notice of Compliance
Formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 201306 February 2017 March 2018 Issued Notice of Compliance
Fosfomycin sodium Antibacterials for systemic use 219662 November 2018 May 2019 Issued Notice of Compliance
Gadoteric acid Contrast media 186333 December 2015 November 2016 Issued Notice of Compliance
Galcanezumab Analgesics 219521 October 2018 July 2019 Issued Notice of Compliance
Glecaprevir, pibrentasvir Antivirals for systemic use 202233 February 2017 August 2017 Issued Notice of Compliance
Glycopyrrolate Drugs for functional gastrointestinal disorders 197038 January 2017 October 2017 Issued Notice of Compliance
Guselkumab Immunosuppressants 200590 January 2017 November 2017 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines 200726 April 2017 February 2018 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 203436 May 2017 March 2019 Issued Notice of Compliance
Hemin Other alimentary tract and metabolism 212276 January 2018 July 2018 Issued Notice of Compliance
Human heterologous liver cells Other alimentary tract and metabolism products 205160 June 2017 July 2018 Cancelled by sponsor
Hydrochlorothiazide, zofenopril calcium Agents acting on the renin-angiotensin system 212396 June 2018 June 2019 Cancelled by sponsor
Hydrogen peroxide Other dermatological preparations 216854 December 2018 August 2019 Cancelled by sponsor
Idarucizumab All other therapeutic products 182503 May 2015 April 2016 Issued Notice of Compliance under the NOC/c Guidance
Immunoglobulin (human) Immune sera and immunoglobulins 194291 October 2016 August 2017 Issued Notice of Compliance
Immunoglobulin G (human) Immune sera and immunoglobulins 202924 April 2017 February 2018 Issued Notice of Compliance
Inotersen sodium Other nervous system drugs 214274 April 2018 October 2018 Issued Notice of Compliance
Inotuzumab ozogamicin Antineoplastic agents 204077 May 2017 March 2018 Issued Notice of Compliance
Insulin degludec Drugs used in diabetes 198124 October 2016 August 2017 Issued Notice of Compliance
Insulin degludec, liraglutide Drugs used in diabetes 194513 June 2017 April 2018 Issued Notice of Compliance
Insulin glargine Drugs used in diabetes 202772 April 2017 February 2019 Cancelled by sponsor
Insulin glargine, lixisenatide Drugs used in diabetes 207006 September 2017 July 2018 Issued Notice of Compliance
Insulin injection human biosynthetic Drugs used in diabetes 189076 September 2016 July 2017 Issued Notice of Compliance
Insulin lispro Drugs used in diabetes 200792 January 2017 November 2017 Issued Notice of Compliance
Iodine Contrast media 196107 September 2016 July 2017 Issued Notice of Compliance
Ioflupane (123I) Diagnostic radiopharmaceuticals 201481 February 2017 December 2017 Issued Notice of Compliance
Iron dextran Antianemic preparations 189897 May 2016 June 2017 Cancelled by sponsor
Iron isomaltoside 1000 Antianemic preparations 193890 July 2016 June 2018 Issued Notice of Compliance
Isavuconazonium sulfate Antimycotics for systemic use 208919 February 2018 December 2018 Issued Notice of Compliance
Ivacaftor, tezacaftor Other respiratory system products 211292 December 2017 June 2018 Issued Notice of Compliance
Ivermectin Anthelmintics 211000 December 2017 September 2018 Issued Notice of Compliance
Ixazomib citrate Antineoplastic agents 190498 February 2016 August 2016 Issued Notice of Compliance
Ixekizumab Immunosuppressants 184993 July 2015 May 2016 Issued Notice of Compliance
Lanadelumab Other hematological agents 213920 March 2018 September 2018 Issued Notice of Compliance
Larotrectinib Antineoplastic agents 219998 November 2018 July 2019 Issued Notice of Compliance Issued Notice of Compliance under the NOC/c Guidance.
Latanoprostene bunod Ophthalmologicals 211732 March 2018 December 2018 Issued Notice of Compliance
Letermovir Antivirals for systemic use 204165 May 2017 November 2017 Issued Notice of Compliance
Levetiracetam Antiepileptics 213656 September 2018 July 2019 Issued Notice of Compliance
Lifitegrast Ophthalmologicals 199810 December 2016 December 2017 Issued Notice of Compliance
Lixisenatide Drugs used in diabetes 193862 June 2016 May 2017 Issued Notice of Compliance
Lonoctocog alfa Antihemorrhagics 190891 February 2016 December 2016 Issued Notice of Compliance
Lorcaserin hydrochloride Antiobesity preparations, excluding diet products 198689 November 2016 February 2018 Cancelled by sponsor
Lorlatinib Antineoplastic agents 215733 June 2018 February 2019 Issued Notice of Compliance under the NOC/c Guidance
Lutetium (177Lu) oxodotretotide Therapeutic radiopharmaceuticals 217184 July 2018 January 2019 Issued Notice of Compliance
Mannitol Diagnostic agents 217446 August 2018 June 2019 Issued Notice of Compliance
Mercaptamine bitartrate Other alimentary tract and metabolism products 191347 March 2016 June 2017 Issued Notice of Compliance
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 204605 May 2017 March 2018 Issued Notice of Compliance
Methoxyflurane Analgesics 204879 June 2017 April 2018 Issued Notice of Compliance
Midostaurin Antineoplastic agents 201101 January 2017 July 2017 Issued Notice of Compliance
Migalastat hydrochloride Other alimentary tract and metabolism products 196956 November 2016 September 2017 Issued Notice of Compliance
Naloxone hydrochloride All other therapeutic products 193199 April 2016 October 2016 Issued Notice of Compliance
Naloxone hydrochloride dihydrate All other therapeutic products 211970 January 2018 June 2019 Cancelled by sponsor
Necitumumab Antineoplastic agents 193689 May 2016 March 2017 Issued Notice of Compliance
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines 195550 July 2016 October 2017 Issued Notice of Compliance
Neratinib maleate Antineoplastic agents 218224 September 2018 July 2019 Issued Notice of Compliance
Netupitant, palonosetron hydrochloride Antiemetics and antinauseants 196495 December 2016 September 2017 Issued Notice of Compliance
Niraparib Antineoplastic agents 216792 September 2018 June 2019 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 190564 March 2016 September 2016 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 193226 May 2016 November 2016 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 193770 July 2016 December 2016 Issued Notice of Compliance
Nusinersen Other drugs for disorders of the musculo-skeletal systemOther 200070 December 2016 June 2017 Issued Notice of Compliance
Obeticholic acid Bile and liver therapy 198418 October 2016 May 2017 Issued Notice of Compliance under the NOC/c Guidance
Ocrelizumab Immunosuppressants 197969 October 2016 August 2017 Issued Notice of Compliance
Ocrelizumab Immunosuppressants 198094 October 2016 February 2018 Issued Notice of Compliance under the NOC/c Guidance
Olaparib Antineoplastic agents 182823 June 2015 April 2016 Issued Notice of Compliance under the NOC/c Guidance
Olaratumab Antineoplastic agents 203478 April 2017 November 2017 Issued Notice of Compliance under the NOC/c Guidance
Osimertinib Antineoplastic agents 188171 November 2015 July 2016 Issued Notice of Compliance under the NOC/c Guidance
Oxycodone Analgesics 198865 November 2015 July 2018 Cancelled by sponsor
Ozenoxacin Antibiotics and chemotherapy for dermatological use 192925 July 2016 May 2017 Issued Notice of Compliance
Panobinostat Antineoplastic agents 187504 November 2015 June 2016 Cancelled by sponsor
Patiromer sorbitex calcium All other therapeutic products 210368 December 2017 October 2018 Issued Notice of Compliance
Patisiran Other nervous system drugs 221896 December 2018 June 2019 Issued Notice of Compliance
Pegaspargase Antineoplastic agents 189795 May 2016 February 2017 Issued Notice of Compliance
Pegfilgrastim Immunostimulants 200807 June 2017 April 2018 Issued Notice of Compliance
Pegfilgrastim Immunostimulants 204841 January 2017 December 2018 Issued Notice of Compliance
Peramivir Antivirals for systemic use 191280 March 2016 January 2017 Issued Notice of Compliance
Perindopril arginine Agents acting on the renin-angiotensin system 201189 August 2017 March 2018 Issued Notice of Compliance
PrabotulinumtoxinA Muscle relaxants 208364 October 2017 August 2018 Issued Notice of Compliance
Pralatrexate Antineoplastic agents 207545 November 2017 October 2018 Issued Notice of Compliance under the NOC/c Guidance
Progesterone Sex hormones and modulators of the genital system 211548 February 2018 August 2018 Issued Notice of Compliance
Propiverine hydrochloride Urologicals 188323 March 2016 January 2017 Issued Notice of Compliance
Rabies immune globulin human Immune sera and immunoglobulins 211541 January 2018 November 2018 Issued Notice of Compliance
Ravulizumab Immunosuppressants 217955 November 2018 August 2019 Issued Notice of Compliance
Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) Antihemorrhagics 180793 April 2015 January 2016 Issued Notice of Compliance
Reslizumab Immunosuppressants 185873 September 2015 July 2016 Issued Notice of Compliance
Ribociclib Antineoplastic agents 203884 May 2017 March 2018 Issued Notice of Compliance
Risankizumab Immunosuppressants 215753 June 2018 April 2019 Issued Notice of Compliance
Rituximab Antineoplastic agents 207702 September 2017 March 2019 Cancelled by sponsor
Rituximab Antineoplastic agents 208107 September 2017 March 2019 Cancelled by sponsor
Rituximab Antineoplastic agents 208204 September 2017 April 2019 Issued Notice of Compliance
Rituximab Antineoplastic agents 224672 March 2019 April 2019 Cancelled by sponsor
Romosozumab Drugs for treatment of bone diseases 197713 October 2016 June 2019 Issued Notice of Compliance
Rupatadine fumarate Antihistamines for systemic use 186488 September 2015 July 2016 Issued Notice of Compliance
Safinamide Anti-parkinson drugs 207115 March 2018 January 2019 Issued Notice of Compliance
Salbutamol sulfate Drugs for obstructive airway diseases 189577 November 2016 November 2017 Issued Notice of Compliance
Sarilumab Immunosuppressants 191745 March 2016 January 2017 Issued Notice of Compliance
Sebelipase alfa Other alimentary tract and metabolism products 204085 April 2017 December 2017 Issued Notice of Compliance under the NOC/c Guidance
Semaglutide Drugs used in diabetes 202059 March 2017 January 2018 Issued Notice of Compliance
Sirukumab Immunosuppressants 205568 June 2017 October 2017 Cancelled by sponsor
Sodium zirconium cyclosilicate All other therapeutic products 218799 September 2018 July 2019 Issued Notice of Compliance
Sofosbuvir, velpatasvir Antivirals for systemic use 190521 January 2016 July 2016 Issued Notice of Compliance
Sofosbuvir, velpatasvir, voxilaprevir Antivirals for systemic use 202324 February 2017 August 2017 Issued Notice of Compliance
Sotagliflozin Drugs used in diabetes 217853 August 2018 June 2019 Cancelled by sponsor
Sucroferric oxyhydroxide All other therapeutic products 201492 February 2017 January 2018 Issued Notice of Compliance
Sugammadex All other therapeutic products 180385 April 2015 February 2016 Issued Notice of Compliance
Suvorexant Psycholeptics 196367 August 2016 November 2018 Issued Notice of Compliance
Tacrolimus Immunosuppressants 209210 April 2018 February 2019 Issued Notice of Compliance
Telotristat etiprate Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 208730 December 2017 October 2018 Issued Notice of Compliance
Tenofovir alafenamide hemifumarate Antivirals for systemic use 193066 July 2016 May 2017 Issued Notice of Compliance
Tibolone Sex hormones and modulators of the genital system 206099 October 2017 May 2019 Issued Notice of Compliance
Tipiracil hydrochloride, trifluridine Antineoplastic agents 205852 July 2017 January 2018 Issued Notice of Compliance
Tisagenlecleucel-T Antineoplastic agents 213547 March 2018 September 2018 Issued Notice of Compliance
Tisagenlecleucel-T Antineoplastic agents 213698 March 2018 September 2018 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 204579 June 2017 May 2019 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 212140 February 2018 August 2019 Issued Notice of Compliance
Triamcinolone hexacetonide Corticosteroids for systemic use 201546 February 2017 December 2017 Issued Notice of Compliance
Varicella-zoster virus glycoprotein E (GE) Vaccines 200244 December 2016 October 2017 Issued Notice of Compliance
Venetoclax Antineoplastic agents 190761 February 2016 September 2016 Issued Notice of Compliance under the NOC/c Guidance
Vernakalant hydrochloride Cardiac therapy 190817 May 2016 March 2017 Issued Notice of Compliance
Volanesorsen Lipid modifying agents 209280 November 2017 November 2018 Issued Notice of Non-compliance - Withdrawal
Vonicog alfa Antihemorrhagics 213188 March 2018 January 2019 Issued Notice of Compliance
Zofenopril calcium Agents acting on the renin-angiotensin system 212392 June 2018 June 2019 Cancelled by sponsor
Submissions formerly under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Submission Control Number Month, Year Submission was Accepted into Review Month, Year Submission Concluded Outcome of Submission
Abacavir sulfate, dolutegravir sodium, lamivudine Antivirals for systemic use 208070 August 2017 October 2017 Issued Notice of Compliance
Abatacept Immunosuppressants 204313 May 2017 March 2018 Issued Notice of Compliance
Abiraterone acetate Endocrine therapy 207915 August 2017 February 2018 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 202245 March 2017 December 2017 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 204299 May 2017 March 2018 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 206921 August 2017 April 2018 Issued Notice of Compliance
Adalimumab Immunosuppressants 197529 September 2016 July 2017 Issued Notice of Compliance
Adalimumab Immunosuppressants 201423 February 2017 December 2017 Issued Notice of Compliance
Adalimumab Immunosuppressants 212133 February 2018 November 2018 Issued Notice of Compliance
Adalimumab Immunosuppressants 213550 March 2018 January 2019 Issued Notice of Compliance
Afatinib dimaleate Antineoplastic agents 209785 December 2017 September 2018 Issued Notice of Compliance
Alectinib Antineoplastic agents 210816 December 2017 June 2018 Issued Notice of Compliance
Anakinra Immunosuppressants 195649 July 2016 May 2017 Issued Notice of Compliance
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 211971 January 2018 November 2018 Issued Notice of Compliance
Apixaban Antithrombotic agents 198842 November 2016 October 2018 Issued Notice of Compliance
Aripiprazole Psycholeptics 200292 January 2017 November 2017 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 205038 June 2017 April 2018 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 217324 July 2018 May 2019 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 223753 February 2019 August 2019 Issued Notice of Compliance
Bazedoxifene acetate, conjugated estrogens Sex hormones and modulators of the genital system 210469 November 2017 September 2018 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 207259 August 2017 June 2018 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 218844 September 2018 June 2018 Issued Notice of Compliance
Blinatumomab Antineoplastic agents 197615 September 2016 April 2017 Issued Notice of Compliance under the NOC/c Guidance
Blinatumomab Antineoplastic agents 204154 May 2017 March 2018 Issued Notice of Compliance
Bosutinib Antineoplastic agents 211317 February 2018 December 2018 Issued Notice of Compliance
Brentuximab vedotin Antineoplastic agents 213996 April 2018 December 2018 Issued Notice of Compliance
Brexpiprazole Psycholeptics 205854 July 2017 February 2019 Issued Notice of Compliance
C1 esterase inhibitor (human) Other hematological agents 197440 September 2016 March 2017 Issued Notice of Compliance
Canagliflozin Drugs used in diabetes 194762 June 2016 April 2017 Issued Notice of Compliance
Canagliflozin Drugs used in diabetes 210676 December 2017 October 2018 Issued Notice of Compliance
Canagliflozin, metformin hydrochloride Drugs used in diabetes 210969 December 2017 October 2018 Issued Notice of Compliance
Canakinumab Immunosuppressants 195617 July 2016 January 2017 Issued Notice of Compliance
Ceftolozane, tazobactam sodium Antibacterials for systemic use 224729 March 2019 August 2019 Issued Notice of Compliance
Certolizumab pegol Immunosuppressants 209082 October 2017 August 2018 Issued Notice of Compliance
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 195789 August 2016 May 2017 Issued Notice of Compliance
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 207251 August 2017 June 2018 Issued Notice of Compliance
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 219784 October 2018 July 2019 Issued Notice of Compliance
Collagenase clostridium histolyticum Other drugs for disorders of the musculo-skeletal system 202488 March 2017 January 2018 Issued Notice of Compliance
Corynebacterium diphtheriae crm-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F Vaccines 216208 June 2018 April 2019 Issued Notice of Compliance
Crizotinib Antineoplastic agents 198322 November 2016 August 2017 Issued Notice of Compliance
Dabrafenib Antineoplastic agents 199381 November 2016 May 2017 Issued Notice of Compliance
Dabrafenib Antineoplastic agents 210753 November 2017 May 2018 Issued Notice of Compliance
Dabrafenib Antineoplastic agents 213581 March 2018 September 2018 Issued Notice of Compliance
Dapagliflozin Drugs used in diabetes 217312 June 2018 April 2019 Issued Notice of Compliance
Daptomycin Antibacterials for systemic use 214792 May 2018 February 2019 Issued Notice of Compliance
Daratumumab Antineoplastic agents 198647 October 2016 April 2017 Issued Notice of Compliance
Daratumumab Antineoplastic agents 212559 January 2018 November 2018 Issued Notice of Compliance
Denosumab Drugs for treatment of bone diseases 203717 April 2017 February 2018 Issued Notice of Compliance
Denosumab Drugs for treatment of bone diseases 205235 June 2017 April 2018 Issued Notice of Compliance
Dexlansoprazole Drugs for acid related disorders 215955 June 2018 April 2019 Issued Notice of Compliance
Dimethyl fumarate Other nervous system drugs 213790 April 2018 February 2019 Issued Notice of Compliance
Dolutegravir Antivirals for systemic use 207076 August 2017 May 2018 Issued Notice of Compliance
Dulaglutide Drugs used in diabetes 201964 March 2017 December 2017 Issued Notice of Compliance
Eculizumab Immunosuppressants 212987 February 2018 August 2018 Issued Notice of Compliance
Eltrombopag olamine Antihemorrhagics 195798 July 2016 May 2017 Issued Notice of Compliance
Eltrombopag olamine Antihemorrhagics 216004 July 2018 May 2019 Issued Notice of Compliance
Eltrombopag olamine Antihemorrhagics 217802 June 2018 June 2019 Cancelled by sponsor
Emicizumab Antihemorrhagics 222209 December 2018 June 2019 Issued Notice of Compliance
Empagliflozin Drugs used in diabetes 193840 May 2016 April 2018 Issued Notice of Compliance
Empagliflozin Drugs used in diabetes 221628 January 2019 April 2019 Issued Notice of Compliance
Empagliflozin, linagliptin Drugs used in diabetes 204589 June 2017 April 2018 Issued Notice of Compliance
Enoxaparin sodium Antithrombotic agents 209807 November 2017 September 2018 Issued Notice of Compliance
Enzalutamide Endocrine therapy 216719 June 2018 December 2018 Issued Notice of Compliance
Eptacog alfa Antihemorrhagics 200866 January 2017 November 2017 Issued Notice of Compliance
Eribulin mesylate Antineoplastic agents 197739 October 2016 August 2017 Issued Notice of Compliance
Erlotinib hydrochloride Antineoplastic agents 194018 June 2016 March 2017 Issued Notice of Compliance
Eslicarbazepine acetate Antiepileptics 208086 September 2017 June 2018 Issued Notice of Compliance
Eslicarbazepine acetate Antiepileptics 209753 November 2017 September 2018 Issued Notice of Compliance
Etanercept Immunosuppressants 193787 May 2016 March 2017 Issued Notice of Compliance
Etanercept Immunosuppressants 213347 March 2018 January 2019 Issued Notice of Compliance
Everolimus Antineoplastic agents 200814 January 2017 November 2017 Issued Notice of Compliance
Evolocumab Lipid modifying agents 207038 August 2017 June 2018 Issued Notice of Compliance
Evolocumab Lipid modifying agents 208904 October 2017 August 2018 Issued Notice of Compliance
Exenatide Drugs used in diabetes 208034 September 2017 July 2018 Issued Notice of Compliance
Fingolimod hydrochloride Immunosuppressants 215423 May 2018 November 2018 Issued Notice of Compliance
Fluticasone furoate Drugs for obstructive airway diseases 208727 October 2017 October 2018 Cancelled by sponsor
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 215148 May 2018 March 2019 Issued Notice of Compliance
Fulvestrant Endocrine therapy 201150 January 2017 November 2017 Issued Notice of Compliance
Gadoterate meglumine Contrast media 205610 June 2017 April 2018 Issued Notice of Compliance
Glecaprevir, pibrentasvir Antivirals for systemic use 222816 December 2018 June 2019 Issued Notice of Compliance
Glycopyrronium bromide, indacaterol maleate Drugs for obstructive airway diseases 198552 November 2016 August 2017 Issued Notice of Compliance
Golimumab Immunosuppressants 197362 September 2016 June 2017 Issued Notice of Compliance
Golimumab Immunosuppressants 205724 June 2017 April 2018 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines 199807 November 2016 May 2017 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) Vaccines 218188 August 2018 June 2019 Cancelled by sponsor
Hydromorphone hydrochloride Analgesics 208033 January 2019 May 2019 Issued Notice of Compliance
Human immunoglobulin Immune sera and immunoglobulins 223245 September 2017 July 2018 Issued Notice of Compliance
Ibrutinib Immunosuppressants 204436 May 2017 October 2017 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 212632 February 2018 July 2018 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 218457 August 2018 February 2019 Issued Notice of Compliance
Icatibant acetate Other hematological agents 217805 September 2018 June 2019 Issued Notice of Compliance
Idelalisib Antineoplastic agents 203513 April 2017 December 2017 Cancelled by sponsor
Immune globulin (human) Immune sera and immunoglobulins 201326 January 2017 October 2017 Issued Notice of Compliance
IncobotulinumtoxinA Muscle relaxants 208713 October 2017 June 2019 Issued Notice of Compliance
Infliximab Immunosuppressants 220321 November 2018 August 2019 Issued Notice of Compliance
Insulin degludec Drugs used in diabetes 208917 October 2017 July 2018 Issued Notice of Compliance
Ipilimumab Antineoplastic agents 202533 February 2017 April 2017 Issued Notice of Compliance
Ivacaftor Other respiratory system products 218044 August 2018 January 2019 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products 198036 October 2016 April 2017 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products 215032 June 2018 December 2018 Issued Notice of Compliance
Ixekizumab Immunosuppressants 204690 June 2017 March 2018 Issued Notice of Compliance
Japanese encephalitis virus vaccine inactivated Vaccines 203520 May 2017 March 2018 Issued Notice of Compliance
Lacosamide Antiepileptics 193732 May 2016 February 2017 Issued Notice of Compliance
Lanreotide acetate Pituitary and hypothalamic hormones and analogues 203094 April 2017 February 2018 Issued Notice of Compliance
Ledipasvir, sofosbuvir Antivirals for systemic use 199607 December 2016 May 2017 Issued Notice of Compliance
Lenvatinib mesylate Antineoplastic agents 197794 November 2016 September 2017 Issued Notice of Compliance
Lenvatinib mesylate Antineoplastic agents 212989 February 2018 December 2018 Issued Notice of Compliance
Leuprolide acetate Endocrine therapy 193372 May 2016 February 2017 Issued Notice of Compliance
Levonorgestrel Sex hormones and modulators of the genital system 204355 May 2017 March 2018 Issued Notice of Compliance
Linagliptin Drugs used in diabetes 194075 June 2016 October 2018 Issued Notice of Compliance
Linagliptin, metformin hydrochloride Drugs used in diabetes 194067 June 2016 May 2017 Cancelled by sponsor
Liraglutide Drugs used in diabetes 196457 August 2016 June 2017 Issued Notice of Compliance
Liraglutide Drugs used in diabetes 200821 January 2017 November 2017 Issued Notice of Compliance
Lurasidone hydrochloride Psycholeptics 197342 September 2016 July 2017 Issued Notice of Compliance
Lurasidone hydrochloride Psycholeptics 205325 June 2017 April 2018 Issued Notice of Compliance
Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid Vaccines 203844 April 2017 February 2018 Issued Notice of Compliance
Mepolizumab Drugs for obstructive airway diseases 208467 September 2017 July 2018 Issued Notice of Compliance
Mepolizumab Drugs for obstructive airway diseases 212242 February 2018 October 2018 Cancelled by sponsor
Methylphenidate hydrochloride Psychoanaleptics 214860 May 2018 March 2019 Issued Notice of Compliance
Midostaurin Antineoplastic agents 210496 December 2017 October 2018 Issued Notice of Compliance
Mifepristone, misoprostol Sex hormones and modulators of the genital system 200856 January 2017 November 2017 Issued Notice of Compliance
Nadroparin calcium Antithrombotic agents 195973 August 2016 July 2017 Issued Notice of Compliance
Nilotinib Antineoplastic agents 211052 December 2017 October 2018 Issued Notice of Compliance
Nivolumab Antineoplastic agents 199379 November 2016 May 2017 Issued Notice of Compliance
Nivolumab Antineoplastic agents 203286 March 2017 November 2017 Issued Notice of Compliance
Nivolumab Antineoplastic agents 203593 April 2017 January 2018 Cancelled by sponsor
Nivolumab Antineoplastic agents 206974 July 2017 March 2018 Issued Notice of Compliance under the NOC/c Guidance
Nivolumab Antineoplastic agents 211838 January 2018 July 2018 Issued Notice of Compliance
Nivolumab Antineoplastic agents 212067 January 2018 November 2018 Issued Notice of Compliance
Norfloxacin Antibacterials for systemic use 208906 October 2017 December 2017 Issued Notice of Compliance
Obinutuzumab Antineoplastic agents 208089 September 2017 July 2018 Issued Notice of Compliance
Olaparib Antineoplastic agents 210204 November 2017 May 2018 Issued Notice of Compliance
Olaparib Antineoplastic agents 219799 November 2018 May 2019 Issued Notice of Compliance
Omalizumab Drugs for obstructive airway diseases 194542 June 2016 April 2017 Issued Notice of Compliance
Ombitasvir, paritaprevir, ritonavir Antivirals for systemic use 195504 July 2016 May 2017 Issued Notice of Compliance
OnabotulinumtoxinA Muscle relaxants 211053 December 2017 October 2018 Issued Notice of Compliance
Osimertinib mesylate Antineoplastic agents 211762 January 2018 July 2018 Issued Notice of Compliance
Outer membrane vesicles (Neisseria meningitidis group B NZ98/254 strain), recombinant Neisseria meningitidis group B NHBA fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B fHBP fusion protein Vaccines 209413 November 2017 August 2018 Issued Notice of Compliance
Palbociclib Antineoplastic agents 195948 August 2016 May 2017 Issued Notice of Compliance
Palbociclib Antineoplastic agents 219500 October 2018 August 2019 Issued Notice of Compliance
Palonosetron hydrochloride Antiemetics and antinauseants 215829 June 2018 April 2019 Issued Notice of Compliance
Panitumumab Antineoplastic agents 193962 June 2016 April 2017 Issued Notice of Compliance
Pasireotide Pituitary and hypothalamic hormones and analogues 209345 November 2017 August 2018 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 201200 January 2017 September 2017 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 203157 March 2017 September 2017 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 209011 January 2018 September 2018 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 212388 May 2018 March 2019 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 215699 September 2017 April 2019 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 216451 June 2018 April 2019 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 218779 August 2018 April 2019 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 219700 October 2018 July 2019 Issued Notice of Compliance
Perampanel Antiepileptics 204327 May 2017 March 2018 Issued Notice of Compliance
Pertuzumab Antineoplastic agents 209467 November 2017 August 2018 Issued Notice of Compliance
Plerixafor Immunostimulants 213345 March 2018 January 2019 Issued Notice of Compliance
Pomalidomide Immunosuppressants 218459 September 2018 July 2019 Issued Notice of Compliance
Ranibizumab Ophthalmologicals 201272 January 2017 November 2017 Issued Notice of Compliance
Regorafenib Antineoplastic agents 203322 April 2017 September 2017 Issued Notice of Compliance
Regorafenib Antineoplastic agents 214314 April 2018 February 2019 Issued Notice of Compliance
Rifaximin Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 209230 February 2018 December 2018 Issued Notice of Compliance
Rituximab Antineoplastic agents 204718 May 2017 March 2018 Issued Notice of Compliance
Rivaroxaban Antithrombotic agents 211611 January 2018 September 2018 Issued Notice of Compliance
Rufinamide Antiepileptics 194343 June 2016 April 2017 Issued Notice of Compliance
Sarilumab Immunosuppressants 211993 January 2018 August 2019 Issued Notice of Compliance
Sevelamer carbonate All other therapeutic products 211598 April 2018 February 2019 Issued Notice of Compliance
Simeprevir Antivirals for systemic use 197253 September 2016 July 2017 Issued Notice of Compliance
Sofosbuvir, velpatasvir Antivirals for systemic use 199753 December 2016 September 2017 Issued Notice of Compliance
Somatropin Pituitary and hypothalamic hormones and analogues 205985 June 2017 April 2018 Issued Notice of Compliance
Sunitinib malate Antineoplastic agents 208710 October 2017 April 2019 Issued Notice of Non-compliance- Withdrawal
Teduglutide Other alimentary tract and metabolism products 223862 February 2019 August 2019 Issued Notice of Compliance
Thioguanine Antineoplastic agents 199259 November 2016 September 2017 Issued Notice of Compliance
Tinzaparin sodium Antithrombotic agents 199839 December 2016 November 2018 Cancelled by sponsor
Tocilizumab Immunosuppressants 204251 May 2017 October 2017 Issued Notice of Compliance
Tocilizumab Immunosuppressants 220039 October 2018 August 2019 Issued Notice of Compliance
Tofacitinib Immunosuppressants 209522 November 2017 September 2018 Issued Notice of Compliance
Tofacitinib Immunosuppressants 209643 December 2017 October 2018 Issued Notice of Compliance
Tofacitinib Immunosuppressants 213578 April 2018 January 2019 Issued Notice of Compliance
Tolvaptan Diuretics 213262 March 2018 January 2019 Issued Notice of Compliance
Trametinib Antineoplastic agents 199382 November 2016 May 2017 Issued Notice of Compliance
Trametinib Antineoplastic agents 210760 November 2017 May 2018 Issued Notice of Compliance
Trametinib Antineoplastic agents 213580 March 2018 September 2018 Issued Notice of Compliance
Venetoclax Antineoplastic agents 214078 March 2018 September 2018 Issued Notice of Compliance
Vilazodone hydrochloride Psychoanaleptics 210066 November 2017 October 2018 Cancelled by sponsor
Vortioxetine hydrobromide Psychoanaleptics 212548 February 2018 December 2018 Issued Notice of Compliance

Questions can be sent to us by email.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: