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 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:
- medicinal ingredient(s)
- month and year the submission was accepted into review
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
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:
- medicinal ingredient(s)
- month and year the submission was accepted into review
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
- 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 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.
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
- Submissions currently under review: Supplemental new drug submissions for new uses
- Submissions formerly under review: New drug submissions
- Submissions formerly under review: Supplemental new drug submissions for new uses
| Medicinal Ingredient(s) | Therapeutic Area | Year, Month 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) |
|---|---|---|---|---|
| 5-Aminolevulinic acid | Antineoplastic agents | 2020-03 | Medexus Inc | Being reviewed under the Priority Review Policy |
| Acetylsalicylic acid, atorvastatin calcium, ramipril | Cardiac therapy | 2020-02 | Ferrer Internacional SA | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Adalimumab | Immunosuppressants | 2018-11 | Sandoz Canada Incorporated | Biosimilar |
| Adalimumab | Immunosuppressants | 2019-09 | BGP Pharma ULC | Biosimilar |
| Adalimumab | Immunosuppressants | 2019-10 | Fresenius Kabi Canada Ltd | Biosimilar
Part of 'aligned review' with a health technology assessment organization |
| Adalimumab | Immunosuppressants | 2020-03 | Pfizer Canada ULC | Biosimilar |
| Amifampridine | Other nervous system drugs | 2020-02 | Medunik Canada | New active substance
Being reviewed under the Priority Review Policy |
| Amifampridine phosphate | Other nervous system drugs | 2020-02 | Catalyst Pharmaceuticals Inc | New active substance
Being reviewed under the Priority Review Policy |
| Amisulfide | Psycholeptics | 2020-03 | KYE Pharmaceuticals Inc | New active substance
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Apomorphine hydrochloride | Anti-parkinson drugs | 2018-08 | Not available | Not available |
| Avanafil | Urologicals | 2019-06 | Acerus Pharmaceuticals Corporation | New active substance |
| Bacillus Calmette-Guerin BCG | Immunostimulants | 2018-12 | Verity Pharmaceuticals Inc | Not applicable |
| Bevacizumab | Antineoplastic agents | 2018-08 | Not available | Not available |
| Binimetinib | Antineoplastic agents | 2020-05 | Pfizer Canada ULC | New active substance Part of 'aligned review' with a health technology assessment organization |
| Bisoprolol fumarate | Beta blocking agents | 2020-05 | JAMP Pharma Corporation | Not applicable |
| Bivalirudin | Antithrombotic agents | 2019-11 | Avir Pharma Inc | Not applicable |
| Brilliant blue G | Ophthalmologicals | 2020-03 | Dutch Ophthalmic Research Center International BV | New active substance
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Bupivacaine | Anesthetics | 2019-12 | Pacira Limited | Not applicable |
| Bupivacaine, meloxicam | Antiinflammatory and antirheumatic products | 2020-01 | Heron Therapeutics, Inc. | Being reviewed under the Priority Review Policy |
| Cedazuridine, decitabine | Antineoplastic agents | 2020-01 | Otsuka Pharmaceutical Co Ltd | New active substance |
| Cyclosporine | Ophthalmologicals | 2020-04 | Sun Pharma Global FZE | Not applicable |
| Dequalinium chloride | Gynecological antiinfectives and antiseptics | 2019-07 | Duchesnay Inc | Not applicable |
| Dermatophagoides farinae, dermatophagoides pteronyssinus | Allergens | 2017-09 | Not available | Not available |
| Drospirenone, estetrol monohydrate | Sex hormones and modulators of the genital system | 2020-05 | Searchlight Pharma Inc | New active substance |
| Emapalumab | Immunosuppressants | 2020-05 | Swedish Orphan Biovitrum AB (publ) | New active substance |
| Encorafenib | Antineoplastic agents | 2020-05 | Pfizer Canada ULC | New active substance Part of 'aligned review' with a health technology assessment organization |
| Enoxaparin sodium | Antithrombotic agents | 2019-11 | Shenzen Techdow Pharmaceutical Co Ltd | Biosimilar |
| Enoxaparin sodium | Antithrombotic agents | 2019-12 | MDA Inc. | Biosimilar |
| Enoxaparin sodium | Antithrombotic agents | 2020-01 | Sandoz Canada Incorporated | Biosimilar |
| Eptinezumab | Analgesics | 2020-03 | Lundbeck Canada Inc | New active substance |
| Estradiol hemihydrate | Sex hormones and modulators of the genital system | 2019-10 | Knight Therapeutics Inc. | Not applicable |
| Estradiol hemihydrate, progesterone | Sex hormones and modulators of the genital system | 2019-11 | Knight Therapeutics Inc. | Not applicable |
| Etanercept | Immunosuppressants | 2020-02 | Lupin Pharma Canada Limited | Biosimilar |
| Etomidate | Anesthetics | 2019-12 | SteriMax Inc | New active substance
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Fedratinib dihydrochloride monohydrate | Antineoplastic agents | 2019-10 | Celgene Inc | New active substance
Part of 'aligned review' with a health technology assessment organization |
| Fibrinogen (human), thrombin (human) | Antihemorrhagics | 2020-05 | Instituto Grifols S.A. | Not applicable |
| Filgotinib | Immunosuppressants | 2020-04 | Gilead Sciences Canada Inc | New active substance
Part of 'aligned review' with a health technology assessment organization |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 2019-03 | Tanvex Biopharm USA, Inc | Biosimilar |
| Foscarnet sodium | Antivirals for systemic use | 2019-12 | SteriMax Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Fostamatinib disodium | Antihemorrhagics | 2020-01 | Rigel Pharmaceuticals Inc. | New active substance |
| Gallium (68Ga) chloride, germanium (68Ge) chloride | Diagnostic radipharmaceuticals | 2019-10 | Eckert & Ziegler Radiopharma GmbH | New active substance |
| Ganciclovir | Ophthalmologicals | 2019-02 | Laboratoires Thea | Not applicable |
| Givosiran | Bile and liver therapy | 2020-04 | Alnylam Netherlands B.V. | New active substance
Being reviewed under the Priority Review Policy |
| Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine | Blood substitutes and perfusion solutions | 2020-03 | Fresenius Kabi Canada Ltd | Not applicable |
| Glycopyrronium bromide, indacaterol acetate, mometasone furoate | Drugs for obstructive airway diseases | 2019-09 | Novartis Pharmaceuticals Canada Inc | Not applicable |
| Haemagglutinin, neuraminidase antigen | Vaccines | 2020-03 | Seqirus UK Limited | Not applicable |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2020-01 | Seqirus UK Limited | Not applicable |
| Halobetasol propionate, tazarotene | Corticosteroids, dermatological preparations | 2018-05 | Not available | Not available |
| Insulin aspart | Drugs used in diabetes | 2019-12 | Sanofi-Aventis Canada Inc | Biosimilar |
| Lasmiditan | Analgesics | 2020-04 | Eli Lilly Canada Inc | New active substance |
| Lefamulin acetate | Antibacterials for systemic use | 2020-01 | Sunovion Pharmaceuticals Canada Inc | New active substance
Being reviewed under the Priority Review Policy |
| Lemborexant | Psycholeptics | 2020-01 | Eisai Limited | New active substance |
| Levothyroxine sodium | Thyroid therapy | 2020-01 | IBSA Institut Biochimique SA | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Luspatercept | Antianemic preparations | 2020-03 | Celgene Inc | New active substance
Being reviewed under the Priority Review Policy |
| Luspatercept | Antianemic preparations | 2020-04 | Celgene Inc | Not applicable |
| Mecasermin | Pituitary, hypothalamic hormones and analogues | 2020-02 | Ipsen Biopharmaceuticals Canada Inc | New active substance |
| Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate | Vaccines | 2020-01 | Sanofi Pasteur Limited | Not applicable |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2016-09 | Not available | Not available |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2017-02 | Not available | Not available |
| Methylene blue | Diagnostic agents | 2018-10 | Pendopharm Division of Pharmascience Inc | Not applicable |
| Obiltoxaximab | Immune sera and immunoglobulins | 2018-10 | Elusys Therapeutics Inc | Extraordinary use submission
New active substance |
| Ofatumumab | Antineoplastic agents | 2020-05 | Novartis Pharmaceuticals Canada Inc | Part of 'aligned review' with a health technology assessment organization |
| Ospemifene | Sex hormones and modulators of the genital system | 2019-03 | Duchesnay Inc | New active substance |
| Ozanimod hydrochloride | Immunosuppressants | 2019-12 | Celgene Inc | New active substance
Part of 'aligned review' with a health technology assessment organization |
| Pegfilgrastim | Immunostimulants | 2019-11 | Purdue Pharma | Biosimilar |
| Pegfilgrastim | Immunostimulants | 2020-01 | Pfizer Canada ULC | Biosimilar |
| Pertuzumab, trastuzumab | Antineoplastic agents | 2020-05 | Hoffmann La Roche Limited | Not applicable |
| Pitolisant | Other nervous system drugs | 2020-05 | Endo Ventures Ltd | New active substance |
| Polatuzumab vedotin | Antineoplastic agents | 2019-11 | Hoffmann La Roche Limited | New active substance
Being reviewed under the Notice of Compliance with Conditions Guidance |
| Recombinant haemagglutinin-strain A (H1N1) virus-like particles, Recombinant haemagglutinin-strain A (H3N2) virus-like particles, Recombinant haemagglutinin-strain B (Victoria lineage) virus-like particles, Recombinant haemagglutinin-strain B (Yamagata lineage) virus-like particles | Vaccines | 2019-09 | Medicago Inc | New active substance |
| Recombinant influenza strain A H1N1 HA protein, recombinant influenza strain A H3N2 HA protein, recombinant influenza strain B (Victoria lineage) HA protein, recombinant influenza strain B (Yamagata lineage) HA protein | Vaccines | 2020-03 | Sanofi Pasteur Limited | Not applicable |
| Remdesivir | Antivirals for systemic use | 2020-06Footnote * | Gilead Sciences Canada Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| Ripretinib | Antineoplastic agents | 2020-03 | Deciphera Pharmaceuticals LLC | New active substance
Being reviewed under the Priority Review Policy |
| Risperidone | Psycholeptics | 2020-01 | HLS Therapeutics Inc | Not applicable |
| Rituximab | Antineoplastic agents | 2020-05 | Amgen Canada Inc | Biosimilar |
| Roxadustat | Antianemic preparations | 2020-03 | AstraZeneca Canada Inc | New active substance |
| Satralizumab | Immunosuppressants | 2019-12 | Hoffmann La Roche Limited | New active substance
Being reviewed under the Priority Review Policy |
| Sodium pertechnetate Tc-99m | Diagnostic radiopharmaceuticals | 2020-01 | BC Cancer, Part of the Provincial Health Services Authority | Not applicable |
| Sonidegib | Antineoplastic agents | 2019-08 | Sun Pharma Global FZE | New active substance
Part of 'aligned review' with a health technology assessment organization |
| Tildrakizumab | Immunosuppressants | 2019-02 | Sun Pharma Global FZE | New active substance
Part of 'aligned review' with a health technology assessment organization |
| Trastuzumab | Antineoplastic agents | 2018-02 | Not available | Not available |
| Trastuzumab (2 submissions under review) |
Antineoplastic agents | 2017-11 | Not available | Not available |
| Trastuzumab | Antineoplastic agents | 2020-04 | Samsung Bioepis Co., Ltd | Biosimilar |
| Treosulfan | Antineoplastic agents | 2020-01 | Marcan Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Trientine hydrochloride | Other alimentary tract and metabolism products | 2019-11 | Marcan Pharmaceuticals Inc | New active substance
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Tucatinib | Antineoplastic agents | 2020-02 | Seattle Genetics Inc | New active substance
Being reviewed under the Priority Review Policy |
| Vitamin D3 | Vitamins | 2019-01 | Galephar Pharmaceutical Research Inc | Not applicable |
| Vitamin K1 | Antihemorrhagics | 2019-08 | Marcan Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Voretigene neparvovec | Ophthalmologicals | 2019-12 | Novartis Pharmaceuticals Canada Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
|
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| Medicinal Ingredient(s) | Therapeutic Area | Year, Month 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) |
|---|---|---|---|---|
| AbobotulinumtoxinA | Muscle relaxants | 2020-04 | Ipsen Biopharm Limited | Not applicable |
| Adalimumab | Immunosuppressants | 2018-10 | Amgen Canada Inc | Biosimilar |
| Adalimumab | Immunosuppressants | 2019-12 | Amgen Canada Inc | Biosimilar |
| Adalimumab | Immunosuppressants | 2020-01 | Samsung Bioepis Co., Ltd | Biosimilar |
| Anakinra | Immunosuppressants | 2020-05 | Swedish Orphan Biovitrum AB (publ) | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Anthrax antigen filtrate | Vaccines | 2020-01 | Emergent Biodefense Operations Lansing LLC | Extraordinary use submission |
| Apremilast | Immunosuppressants | 2019-12 | Celgene Inc | Not applicable |
| Atezolizumab | Antineoplastic agents | 2020-02 | Hoffmann La Roche Limited | Not applicable |
| Atezolizumab | Antineoplastic agents | 2020-05 | Hoffmann La Roche Limited | Not applicable |
| Avelumab | Antineoplastic agents | 2019-06 | EMD Serono a Division of EMD Inc Canada | Not applicable |
| Bevacizumab | Antineoplastic agents | 2019-11 | Amgen Canada Inc | Biosimilar |
| Brigatinib | Antineoplastic agents | 2020-05 | Takeda Canada Inc | Not applicable |
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2020-05 | Avir Pharma Inc | Not applicable |
| Burosumab | Drugs for the treatment of bone diseases | 2019-08 | Kyowa Kirin Limited | Not applicable |
| Canagliflozin, metformin hydrochloride | Drugs used in diabetes | 2019-11 | Janssen Inc | Not applicable |
| Canakinumab | Immunosuppressants | 2020-04 | Novartis Pharmaceuticals Canada Inc | Not applicable |
| Carfilzomib | Antineoplastic agents | 2020-04 | Amgen Canada Inc | Not applicable |
| Carglumic acid | Other alimentary tract and metabolism products | 2019-06 | Recordati Rare Diseases | Being reviewed under the Priority Review Policy |
| Dapagliflozin propanediol | Drugs used in diabetes | 2020-01 | AstraZeneca Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
| Daratumumab | Antineoplastic agents | 2020-01 | Janssen Inc | 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 | 2018-11 | Sanofi Pasteur Limited | Not applicable |
| Diphtheria toxoid, filamentous hemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid | Vaccines | 2018-11 | Sanofi Pasteur Limited | Not applicable |
| Dolutegravir | Antivirals for systemic use | 2020-04 | ViiV Healthcare ULC | Not applicable |
| Dulaglutide | Drugs used in diabetes | 2019-11 | Eli Lilly Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2019-10 | Sanofi-Aventis Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2020-01 | Sanofi-Aventis Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2020-04 | Sanofi-Aventis Canada Inc | Not applicable |
| Durvalumab | Antineoplastic agents | 2019-11 | AstraZeneca Canada Inc | Not applicable |
| Emtricitabine, tenofovir alafenamide | Antivirals for systemic use | 2020-02 | Gilead Sciences Canada Inc | Not applicable |
| Enzalutamide | Endocrine therapy | 2019-12 | Astellas Pharma Canada Inc | Being reviewed under the Priority Review Policy |
| Etanercept | Immunosuppressants | 2019-05 | Sandoz Canada Incorporated | Biosimilar |
| Etanercept | Immunosuppressants | 2019-10 | Samsung Bioepis Co., Ltd | Biosimilar |
| Fibrinogen (human) | Antihemorrhagics | 2019-06 | CSL Behring Canada Inc | Not applicable |
| Fibrinogen (human) | Antihemorrhagics | 2019-09 | Octapharma Pharmazeutika Produktionsges M B H | Not applicable |
| Flibanserin | Other gynecologicals | 2019-07 | Sprout Pharmaceuticals Canada, Ltd | Not applicable |
| Galcanezumab | Analgesics | 2019-11 | Eli Lilly Canada Inc | Not applicable |
| Guselkumab | Immunosuppressants | 2019-11 | Janssen Inc | Not applicable |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2019-08 | Sanofi Pasteur Limited | Not applicable |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2020-05 | Seqirus UK Limited | Not applicable |
| Ibrutinib | Antineoplastic agents | 2020-02 | Janssen Inc | Not applicable |
| IncobotulinumtoxinA | Muscle relaxants | 2020-01 | Merz Pharmaceuticals GmbH | Not applicable |
| Insulin degludec, liragutide | Drugs used in diabetes | 2020-01 | Novo Nordisk Canada Inc | Not applicable |
| Insulin glargine, lixisenatide | Drugs used in diabetes | 2019-11 | Sanofi-Aventis Canada Inc | Not applicable |
| Ixekizumab | Immunosuppressants | 2019-12 | Eli Lilly Canada Inc | Not applicable |
| Liraglutide | Drugs used in diabetes | 2020-05 | Novo Nordisk Canada Inc | Not applicable |
| Macitentan | Antihypertensives | 2019-01 | Janssen Inc | Not applicable |
| Niraparib | Antineoplastic agents | 2020-04 | GlaxoSmithKline Inc | Being reviewed under the Priority Review Policy |
| Nivolumab | Antineoplastic agents | 2020-01 | Bristol-Myers Squibb Canada | Not applicable |
| Nivolumab | Antineoplastic agents | 2020-03 | Bristol-Myers Squibb Canada | Not applicable |
| Olaparib | Antineoplastic agents | 2020-02 | AstraZeneca Canada Inc | Being reviewed under the Priority Review Policy |
| OnabotulinumtoxinA | Muscle relaxants | 2020-05 | Allergan Inc | Not applicable |
| Pembrolizumab | Antineoplastic agents | 2019-12 | Merck Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Pembrolizumab | Antineoplastic agents | 2020-04 | Merck Canada Inc | Being reviewed under the Notice of Compliance with Conditions Guidance |
| Pertuzumab, trastuzumab | Antineoplastic agents | 2019-09 | Hoffmann La Roche Limited | Not applicable |
| Ranibizumab | Opthalmologicals | 2019-11 | Novartis Pharmaceuticals Canada Inc | Not applicable |
| Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | 2019-02 | Merck Canada Inc | Not applicable |
| Ribociclib succinate | Antineoplastic agents | 2019-12 | Novartis Pharmaceuticals Canada Inc | Not applicable |
| Rivaroxaban | Antithrombotic agents | 2020-02 | Bayer Inc | Not applicable |
| Rivaroxaban | Antithrombotic agents | 2020-03 | Bayer Inc | Being reviewed under the Priority Review Policy |
| Secukinumab | Immunosuppressants | 2020-03 | Novartis Pharmaceuticals Canada Inc | Not applicable |
| Semaglutide | Drugs used in diabetes | 2019-10 | Novo Nordisk Canada Inc | Not applicable |
| Sofosbuvir, velpatasvir | Antivirals for systemic use | 2020-01 | Gilead Sciences Canada Inc | Not applicable |
| Somatropin R-DNA origin | Pituitary and hypothalamic hormones and analogues | 2019-08 | Pfizer Canada ULC | Not applicable |
| Standardized short ragweed pollen allergenic extract | Allergens | 2020-02 | ALK - Abello A/S | Not applicable |
| Sugammadex | All other therapeutic products | 2020-01 | Merck Canada Inc | Not applicable |
| Sulfur hexafluoride | Contrast media | 2019-11 | Bracco Imaging Canada | Not applicable |
| Teriflunomide | Immunosuppressants | 2019-11 | Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc | Not applicable |
| Ticagrelor | Antithrombotic agents | 2019-10 | AstraZeneca Canada Inc | Not applicable |
| Tretinoin | Anti-acne preparations | 2020-03 | Bausch Health, Canada Inc. | Not applicable |
| Trastuzumab | Antineoplastic agents | 2020-05 | Celltrion Healthcare Co Ltd | Biosimilar |
| Umeclidinium bromide | Drugs for obstructive airway diseases | 2019-01 | GlaxoSmithKline Inc | Not applicable |
| Ustekinumab | Immunosuppressants | 2019-08 | Janssen Inc | Not applicable |
| Medicinal Ingredient(s) | Therapeutic Area | Submission Control Number | Year, Month Submission was Accepted into Review | Year, Month Submission Concluded | Outcome of SubmissionFootnote a |
|---|---|---|---|---|---|
| Abemaciclib | Antineoplastic agents | 215268 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Acalabrutinib | Antineoplastic agents | 214504 | 2018-04 | 2019-08 | Issued Notice of Compliance under the NOC/c Guidance |
| Acetaminophen | Analgesics | 209478 | 2018-02 | 2018-11 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 203250 | 2017-04 | 2018-05 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 203292 | 2017-04 | 2018-05 | Issued Notice of Compliance |
| Alectinib | Antineoplastic agents | 189442 | 2016-02 | 2016-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Alirocumab | Lipid modifying agents | 183116 | 2015-06 | 2016-04 | Issued Notice of Compliance |
| Alpelisib | Antineoplastic agents | 226941 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Alvimopan | Drugs for constipation | 189825 | 2016-03 | 2017-03 | Cancelled by sponsor |
| Amlodipine besylate | Calcium channel blockers | 211854 | 2018-07 | 2019-01 | Issued Notice of Compliance |
| Amoxicillin sodium, clavulanic acid | Antibacterials for systemic use | 221964 | 2019-04 | 2020-01 | Issued Notice of Compliance |
| Anthrax antigen filtrate | Vaccines | 212387 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Anthrax immunoglobulin (human) | Immune sera and immunoglobulins | 200446 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Antihemophilic factor (human), Von Willebrand factor (human) | Antihemorrhagics | 194071 | 2017-06 | 2018-05 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 189709 | 2016-01 | 2016-11 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant, B-domain deleted, pegylated) | Antihemorrhagics | 210935 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Antihemophilic factor VIII (Recombinant, B-domain truncated), pegylated | Antihemorrhagics | 218531 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Apalutamide | Endocrine therapy | 211942 | 2018-01 | 2018-07 | Issued Notice of Compliance |
| Ataluren | Other drugs for disorders of the musculo-skeletal system | 186992 | 2015-09 | 2016-03 | Cancelled by sponsor |
| Ataluren | Other drugs for disorders of the musculo-skeletal system | 217349 | 2018-09 | 2019-10 | Cancelled by sponsor |
| Atezolizumab | Antineoplastic agents | 196843 | 2016-08 | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Avelumab | Antineoplastic agents | 204052 | 2017-04 | 2017-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Avelumab | Antineoplastic agents | 208742 | 2017-09 | 2018-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Axicabtagene ciloleucel | Antineoplastic agents | 218389 | 2018-08 | 2019-02 | Issued Notice of Compliance |
| Baloxavir marboxil | Antivirals for systemic use | 227361 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Baricitinib | Antiinflammatory and antirheumatic products | 193687 | 2016-05 | 2018-08 | Issued Notice of Compliance |
| Belinostat | Antineoplastic agents | 208886 | 2017-12 | 2019-11 | Cancelled by sponsor |
| Benralizumab | Immunosuppressants | 204008 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Bepotastine besilate | Ophthalmologicals | 179294 | 2015-10 | 2016-07 | Issued Notice of Compliance |
| Betamethasone valerate, fusidic acid | Corticosteroids, dermatological preparations | 203765 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Betula verrucosa extract | Nasal preparations | 227270 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 201427 | 2017-02 | 2018-04 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 218183 | 2018-08 | 2019-06 | Issued Notice of Compliance |
| Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 203718 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Bilastine | Antihistamines for systemic use | 184231 | 2015-06 | 2016-04 | Issued Notice of Compliance |
| Bisoprolol fumarate | Beta blocking agents | 203050 | 2017-07 | 2019-11 | Issued Notice of Compliance |
| Blinatumomab | Antineoplastic agents | 181723 | 2015-04 | 2015-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Botulinum antitoxin, serotypes A, B, C, D, E, F, G | Immune sera and immunoglobulins | 190645 | 2016-02 | 2016-12 | Issued Notice of Compliance |
| Brexpiprazole | Psycholeptics | 192684 | 2016-04 | 2017-02 | Issued Notice of Compliance |
| Brigatinib | Antineoplastic agents | 210369 | 2017-11 | 2018-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Brivaracetam | Antiepileptics | 183355 | 2015-05 | 2016-03 | Issued Notice of Compliance |
| Brodalumab | Immunosuppressants | 195317 | 2016-07 | 2018-03 | Issued Notice of Compliance |
| Brolucizumab | Ophthalmologicals | 226224 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 227232 | 2019-05 | 2019-11 | Issued Notice of Compliance |
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 220876 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Buprenorphine | Other nervous system drugs | 215660 | 2018-05 | 2018-11 | Issued Notice of Compliance |
| Buprenorphine hydrochloride | Other nervous system drugs | 196428 | 2016-08 | 2017-06 | Issued Notice of Compliance |
| Buprenorphine hydrochloride | Other nervous system drugs | 204746 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Bupropion hydrochloride, naltrexone hydrochloride | Antiobesity preparations, excluding diet products | 202774 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Burosumab | Drugs for treatment of bone diseases | 216239 | 2018-06 | 2018-12 | Issued Notice of Compliance |
| C1 esterase inhibitor (human) | Other hematological agents | 198308 | 2016-11 | 2017-09 | Issued Notice of Compliance |
| Cabotegravir, rilpivirine | Antivirals for systemic use | 227315 | 2019-05 | 2020-30 | Issued Notice of Compliance |
| Cabozantinib | Antineoplastic agents | 206230 | 2017-07 | 2018-09 | Issued Notice of Compliance |
| Caffeine citrate | Psychoanaleptics | 225810 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Calcifediol | Vitamins | 205392 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Canakinumab | Immunosuppressants | 213303 | 2018-06 | 2018-12 | Cancelled by sponsor |
| Caplacizumab | Antithrombotic agents | 230001 | 2019-08 | 2020-02 | Issued Notice of Compliance |
| Carfilzomib | Antineoplastic agents | 184479 | 2015-07 | 2016-01 | Issued Notice of Compliance |
| Cefixime | Antibacterials for systemic use | 189720 | 2016-05 | 2017-10 | Issued Notice of Compliance |
| Cemiplimab | Antineoplastic agents | 218718 | 2018-08 | 2019-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Cenegermin | Ophthalmologicals | 218145 | 2018-08 | 2019-02 | Issued Notice of Compliance |
| Cerliponase alfa | Other alimentary tract and metabolism products | 216539 | 2018-06 | 2018-12 | Issued Notice of Compliance |
| Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride | Blood substitutes and perfusion solutions | 223801 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Cidofovir | Antivirals for systemic use | 200865 | 2017-04 | 2018-03 | Issued Notice of Compliance |
| Cinnarizine, dimenhydrinate | Other nervous system drugs | 195151 | 2016-09 | 2019-02 | Issued Notice of Non-compliance- Withdrawal |
| Cladribine | Immunosuppressants | 200943 | 2017-02 | 2017-11 | Issued Notice of Compliance |
| Clozapine | Psycholeptics | 193638 | 2016-05 | 2016-11 | Issued Notice of Compliance |
| Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | 201114 | 2017-02 | 2017-11 | Issued Notice of Compliance |
| Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 199705 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Cobimetinib fumarate | Antineoplastic agents | 182788 | 2015-04 | 2016-02 | Issued Notice of Compliance |
| Crisaborole | Other dermatological preparations | 206906 | 2017-08 | 2018-06 | Issued Notice of Compliance |
| Cyclosporine | Ophthalmologicals | 194580 | 2016-08 | 2018-04 | Issued Notice of Non-compliance- Withdrawal |
| Cyclosporine | Ophthalmologicals | 215813 | 2018-07 | 2018-12 | Issued Notice of Compliance |
| Cysteamine hydrochloride | Ophthalmologicals | 211635 | 2018-02 | 2019-02 | Issued Notice of Compliance |
| Daclizumab | Immunosuppressants | 190458 | 2016-02 | 2016-12 | Issued Notice of Compliance |
| Dacomitinib | Antineoplastic agents | 214572 | 2018-05 | 2019-02 | Issued Notice of Compliance |
| Dalbavancin | Antibacterials for systemic use | 212390 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | 187648 | 2015-11 | 2016-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Darolutamide | Endocrine therapy | 226146 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Darvadstrocel | Unassigned | 217347 | 2018-08 | 2019-06 | Cancelled by sponsor |
| Decitabine | Antineoplastic agents | 207372 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Decitabine | Antineoplastic agents | 217663 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Defibrotide | Antithrombotic agents | 200808 | 2017-01 | 2017-07 | Issued Notice of Compliance |
| Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 195186 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Desvenlafaxine | Psychoanaleptics | 199626 | 2017-02 | 2017-08 | Issued Notice of Compliance |
| Dexamethasone sodium phosphate, netilmicin sulfate | Ophthalmologicals | 212391 | 2018-02 | 2019-10 | Issued Notice of Compliance |
| Dinutuximab | Antineoplastic agents | 212066 | 2018-02 | 2018-11 | Issued Notice of Compliance |
| Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic | All other non-therapeutic products | 220402 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Dolutegravir sodium, rilpivirine hydrochloride | Antivirals for systemic use | 206402 | 2017-07 | 2018-05 | Issued Notice of Compliance |
| Dolutegravir, lamivudine | Antivirals for systemic use | 220275 | 2018-10 | 2019-08 | Issued Notice of Compliance |
| Doravirine | Antivirals for systemic use | 211293 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 211708 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Dotatate | Diagnostic radiopharmaceuticals | 218346 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Dupilumab | Immunosuppressants | 201285 | 2017-02 | 2017-11 | Issued Notice of Compliance |
| Durvalumab | Antineoplastic agents | 202953 | 2017-03 | 2017-11 | Issued Notice of Compliance under the NOC/c Guidance |
| Durvalumab | Antineoplastic agents | 208834 | 2017-09 | 2018-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Edaravone | Other nervous system drugs | 214391 | 2018-04 | 2018-10 | Issued Notice of Compliance |
| Edoxaban | Antithrombotic agents | 187363 | 2015-12 | 2016-11 | Issued Notice of Compliance |
| Elagolix | Sex hormones and modulators of the genital system | 209513 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Elbasvir, grazoprevir | Antivirals for systemic use | 185866 | 2015-07 | 2016-01 | Issued Notice of Compliance |
| Eliglustat tartrate | Other alimentary tract and metabolism products | 183050 | 2015-05 | 2017-04 | Issued Notice of Compliance |
| Elotuzumab | Antineoplastic agents | 188144 | 2015-12 | 2016-06 | Issued Notice of Compliance |
| Eluxadoline | Drugs for functional gastrointestinal disorders | 190162 | 2016-04 | 2017-01 | Issued Notice of Compliance |
| Emicizumab | Antihemorrhagics | 212635 | 2018-02 | 2018-08 | Issued Notice of Compliance |
| Enasidenib mesylate | Antineoplastic agents | 217033 | 2018-07 | 2019-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Entrectinib | Antineoplastic agents | 227517 | 2019-06 | 2020-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Entrectinib | Antineoplastic agents | 228159 | 2019-07 | 2020-05 | Issued Notice of Compliance |
| Erdafitinib | Antineoplastic agents | 224529 | 2019-03 | 2019-10 | Issued Notice of Compliance under the NOC/c Guidance |
| Erenumab | Analgesics | 208607 | 2017-10 | 2018-08 | Issued Notice of Compliance |
| Ertugliflozin pidolate | Drugs used in diabetes | 204724 | 2017-07 | 2018-05 | Issued Notice of Compliance |
| Ertugliflozin pidolate, metformin hydrochloride | Drugs used in diabetes | 201005 | 2017-08 | 2018-05 | Issued Notice of Compliance |
| Ertugliflozin pidolate, sitagliptin phosphate monohydrate | Drugs used in diabetes | 201006 | 2017-07 | 2018-05 | Issued Notice of Compliance |
| Esketamine hydrochloride | Psychoanaleptics | 222855 | 2019-01 | 2020-05 | Issued Notice of Compliance |
| Estriol, lactobacillus acidophilus | Sex hormones and modulators of the genital system | 203472 | 2017-06 | 2019-01 | Issued a Notice of Deficiency-Withdrawal |
| Etanercept | Immunosuppressants | 193864 | 2016-06 | 2017-04 | Issued Notice of Compliance |
| Etonogestrel | Sex hormones and modulators of the genital system | 226314 | 2019-05 | 2020-05 | Issued Notice of Compliance |
| Fibrinogen (human) | Antihemorrhagics | 195870 | 2016-08 | 2017-06 | Issued Notice of Compliance |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 212016 | 2018-02 | 2019-08 | Cancelled by sponsor |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 214080 | 2018-04 | 2020-04 | Issued Notice of Compliance |
| Flibanserin | Other gynecologicals | 189352 | 2016-04 | 2018-02 | Issued Notice of Compliance |
| Florbetaben (18F) | Diagnostic radiopharmaceuticals | 193105 | 2016-04 | 2017-02 | Issued Notice of Compliance |
| Fluocinolone acetonide | Ophthalmologicals | 201510 | 2017-02 | 2018-11 | Issued Notice of Compliance |
| Fluorouracil | Antineoplastic agents | 211768 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Fluoxetine hydrochloride | Psychoanaleptics | 198520 | 2016-12 | 2017-06 | Issued Notice of Compliance |
| Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 204880 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Fluticasone propionate | Drugs for obstructive airway diseases | 197873 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Fluticasone proprionate, salmeterol xinafoate | Drugs for obstructive airway diseases | 197974 | 2016-11 | 2018-04 | Issued Notice of Compliance |
| Follitropin delta | Sex hormones and modulators of the genital system | 188743 | 2016-01 | 2018-03 | Issued Notice of Compliance |
| Formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | 201306 | 2017-02 | 2018-03 | Issued Notice of Compliance |
| Fosfomycin sodium | Antibacterials for systemic use | 219662 | 2018-11 | 2019-05 | Issued Notice of Compliance |
| Fremanezumab | Analgesics | 226828 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Gadoteric acid | Contrast media | 186333 | 2015-12 | 2016-11 | Issued Notice of Compliance |
| Galcanezumab | Analgesics | 219521 | 2018-10 | 2019-07 | Issued Notice of Compliance |
| Gallium (68Ga) chloride | Diagnostic radiopharmaceuticals | 221824 | 2019-04 | 2019-11 | Issued Notice of Compliance |
| Gemtuzumab ozogamicin | Antineoplastic agents | 223091 | 2019-02 | 2019-11 | Issued Notice of Compliance |
| Gilteritinib fumarate | Antineoplastic agents | 227918 | 2019-06 | 2019-12 | Issued Notice of Compliance |
| Glasdegib | Antineoplastic agents | 225793 | 2019-07 | 2020-04 | Issued Notice of Compliance |
| Glecaprevir, pibrentasvir | Antivirals for systemic use | 202233 | 2017-02 | 2017-08 | Issued Notice of Compliance |
| Glucagon | Pancreatic hormones | 220839 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Glycopyrrolate | Drugs for functional gastrointestinal disorders | 197038 | 2017-01 | 2017-10 | Issued Notice of Compliance |
| Guselkumab | Immunosuppressants | 200590 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 200726 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 203436 | 2017-05 | 2019-03 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 222669 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Hemin | Other alimentary tract and metabolism | 212276 | 2018-01 | 2018-07 | Issued Notice of Compliance |
| Human heterologous liver cells | Other alimentary tract and metabolism products | 205160 | 2017-06 | 2018-07 | Cancelled by sponsor |
| Hydrochlorothiazide, zofenopril calcium | Agents acting on the renin-angiotensin system | 212396 | 2018-06 | 2019-06 | Cancelled by sponsor |
| Hydrogen peroxide | Other dermatological preparations | 216854 | 2018-12 | 2019-08 | Cancelled by sponsor |
| Icosapent ethyl | Lipid modifying agents | 227235 | 2019-07 | 2019-12 | Issued Notice of Compliance |
| Idarucizumab | All other therapeutic products | 182503 | 2015-05 | 2016-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Immunoglobulin (human) | Immune sera and immunoglobulins | 194291 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Immunoglobulin (human) | Immune sera and immunoglobulins | 226576 | 2019-06 | 2019-12 | Issued Notice of Compliance |
| Immunoglobulin G (human) | Immune sera and immunoglobulins | 202924 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Indacaterol acetate, mometasone furoate | Drugs for obstructive airway diseases | 227987 | 2019-07 | 2020-05 | Issued Notice of Compliance |
| Infliximab | Immunosuppressants | 226189 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Inotersen sodium | Other nervous system drugs | 214274 | 2018-04 | 2018-10 | Issued Notice of Compliance |
| Inotuzumab ozogamicin | Antineoplastic agents | 204077 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Insulin degludec | Drugs used in diabetes | 198124 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Insulin degludec, liraglutide | Drugs used in diabetes | 194513 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Insulin glargine | Drugs used in diabetes | 202772 | 2017-04 | 2019-02 | Cancelled by sponsor |
| Insulin glargine, lixisenatide | Drugs used in diabetes | 207006 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Insulin injection human biosynthetic | Drugs used in diabetes | 189076 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Insulin lispro | Drugs used in diabetes | 200792 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Iodine | Contrast media | 196107 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Ioflupane (123I) | Diagnostic radiopharmaceuticals | 201481 | 2017-02 | 2017-12 | Issued Notice of Compliance |
| Iron dextran | Antianemic preparations | 189897 | 2016-05 | 2017-06 | Cancelled by sponsor |
| Iron isomaltoside 1000 | Antianemic preparations | 193890 | 2016-07 | 2018-06 | Issued Notice of Compliance |
| Isatuximab | Antineoplastic agents | 229245 | 2019-07 | 2020-04 | Issued Notice of Compliance |
| Isavuconazonium sulfate | Antimycotics for systemic use | 208919 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Ivacaftor, tezacaftor | Other respiratory system products | 211292 | 2017-12 | 2018-06 | Issued Notice of Compliance |
| Ivermectin | Anthelmintics | 211000 | 2017-12 | 2018-09 | Issued Notice of Compliance |
| Ixazomib citrate | Antineoplastic agents | 190498 | 2016-02 | 2016-08 | Issued Notice of Compliance |
| Ixekizumab | Immunosuppressants | 184993 | 2015-07 | 2016-05 | Issued Notice of Compliance |
| Lanadelumab | Other hematological agents | 213920 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Larotrectinib | Antineoplastic agents | 219998 | 2018-11 | 2019-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Latanoprostene bunod | Ophthalmologicals | 211732 | 2018-03 | 2018-12 | Issued Notice of Compliance |
| Letermovir | Antivirals for systemic use | 204165 | 2017-05 | 2017-11 | Issued Notice of Compliance |
| Levetiracetam | Antiepileptics | 213656 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Lifitegrast | Ophthalmologicals | 199810 | 2016-12 | 2017-12 | Issued Notice of Compliance |
| Lixisenatide | Drugs used in diabetes | 193862 | 2016-06 | 2017-05 | Issued Notice of Compliance |
| Lonoctocog alfa | Antihemorrhagics | 190891 | 2016-02 | 2016-12 | Issued Notice of Compliance |
| Lorcaserin hydrochloride | Antiobesity preparations, excluding diet products | 198689 | 2016-11 | 2018-02 | Cancelled by sponsor |
| Lorlatinib | Antineoplastic agents | 215733 | 2018-06 | 2019-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Lutetium (177Lu) oxodotretotide | Therapeutic radiopharmaceuticals | 217184 | 2018-07 | 2019-01 | Issued Notice of Compliance |
| Mannitol | Diagnostic agents | 217446 | 2018-08 | 2019-06 | Issued Notice of Compliance |
| Mercaptamine bitartrate | Other alimentary tract and metabolism products | 191347 | 2016-03 | 2017-06 | Issued Notice of Compliance |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 204605 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Methoxyflurane | Analgesics | 204879 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Midostaurin | Antineoplastic agents | 201101 | 2017-01 | 2017-07 | Issued Notice of Compliance |
| Migalastat hydrochloride | Other alimentary tract and metabolism products | 196956 | 2016-11 | 2017-09 | Issued Notice of Compliance |
| Mometasone furoate | Corticosteroids, dermatological preparations | 199704 | 2017-09 | 2019-10 | Cancelled by sponsor |
| Naloxone hydrochloride | All other therapeutic products | 193199 | 2016-04 | 2016-10 | Issued Notice of Compliance |
| Naloxone hydrochloride dihydrate | All other therapeutic products | 211970 | 2018-01 | 2019-06 | Cancelled by sponsor |
| Naproxen sodium, sumatriptan succinate | Analgesics | 225848 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Necitumumab | Antineoplastic agents | 193689 | 2016-05 | 2017-03 | Issued Notice of Compliance |
| Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B | Vaccines | 195550 | 2016-07 | 2017-10 | Issued Notice of Compliance |
| Neratinib maleate | Antineoplastic agents | 218224 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Netupitant, palonosetron hydrochloride | Antiemetics and antinauseants | 196495 | 2016-12 | 2017-09 | Issued Notice of Compliance |
| Nicardipine hydrochloride | Calcium channel blockers | 216257 | 2018-07 | 2020-04 | Issued Notice of Non-compliance - Withdrawal |
| Niraparib | Antineoplastic agents | 216792 | 2018-09 | 2019-06 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | 190564 | 2016-03 | 2016-09 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | 193226 | 2016-05 | 2016-11 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | 193770 | 2016-07 | 2016-12 | Issued Notice of Compliance |
| Nusinersen | Other drugs for disorders of the musculo-skeletal systemOther | 200070 | 2016-12 | 2017-06 | Issued Notice of Compliance |
| Obeticholic acid | Bile and liver therapy | 198418 | 2016-10 | 2017-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Ocrelizumab | Immunosuppressants | 197969 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Ocrelizumab | Immunosuppressants | 198094 | 2016-10 | 2018-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Olaparib | Antineoplastic agents | 182823 | 2015-06 | 2016-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Olaratumab | Antineoplastic agents | 203478 | 2017-04 | 2017-11 | Issued Notice of Compliance under the NOC/c Guidance |
| Osimertinib | Antineoplastic agents | 188171 | 2015-11 | 2016-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Oxycodone | Analgesics | 198865 | 2015-11 | 2018-07 | Cancelled by sponsor |
| Ozenoxacin | Antibiotics and chemotherapy for dermatological use | 192925 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Panobinostat | Antineoplastic agents | 187504 | 2015-11 | 2016-06 | Cancelled by sponsor |
| Patiromer sorbitex calcium | All other therapeutic products | 210368 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Patisiran | Other nervous system drugs | 221896 | 2018-12 | 2019-06 | Issued Notice of Compliance |
| Pegaspargase | Antineoplastic agents | 189795 | 2016-05 | 2017-02 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 204841 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 200807 | 2017-01 | 2018-12 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 220445 | 2019-05 | 2020-04 | Issued Notice of Compliance |
| Peramivir | Antivirals for systemic use | 191280 | 2016-03 | 2017-01 | Issued Notice of Compliance |
| Perindopril arginine | Agents acting on the renin-angiotensin system | 201189 | 2017-08 | 2018-03 | Issued Notice of Compliance |
| Plecanatide | Drugs for constipation | 215288 | 2018-12 | 2019-10 | Issued Notice of Compliance |
| PrabotulinumtoxinA | Muscle relaxants | 208364 | 2017-10 | 2018-08 | Issued Notice of Compliance |
| Pralatrexate | Antineoplastic agents | 207545 | 2017-11 | 2018-10 | Issued Notice of Compliance under the NOC/c Guidance |
| Prasterone | Anabolic agents for systemic use | 198822 | 2016-12 | 2019-11 | Issued Notice of Compliance |
| Progesterone | Sex hormones and modulators of the genital system | 211548 | 2018-02 | 2018-08 | Issued Notice of Compliance |
| Propiverine hydrochloride | Urologicals | 188323 | 2016-03 | 2017-01 | Issued Notice of Compliance |
| Rabies immunoglobulin, human | Immune sera and immunoglobulins | 211541 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Ravulizumab | Immunosuppressants | 217955 | 2018-11 | 2019-08 | Issued Notice of Compliance |
| Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) | Antihemorrhagics | 180793 | 2015-04 | 2016-01 | Issued Notice of Compliance |
| Reslizumab | Immunosuppressants | 185873 | 2015-09 | 2016-07 | Issued Notice of Compliance |
| Ribociclib | Antineoplastic agents | 203884 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Risankizumab | Immunosuppressants | 215753 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 207702 | 2017-09 | 2019-03 | Cancelled by sponsor |
| Rituximab | Antineoplastic agents | 208107 | 2017-09 | 2019-03 | Cancelled by sponsor |
| Rituximab | Antineoplastic agents | 208204 | 2017-09 | 2019-04 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 224672 | 2019-03 | 2019-04 | Cancelled by sponsor |
| Rituximab | Antineoplastic agents | 214058 | 2018-04 | 2020-04 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 224164 | 2019-03 | 2020-05 | Issued Notice of Compliance |
| Romosozumab | Drugs for treatment of bone diseases | 197713 | 2016-10 | 2019-06 | Issued Notice of Compliance |
| Rupatadine fumarate | Antihistamines for systemic use | 186488 | 2015-09 | 2016-07 | Issued Notice of Compliance |
| Safinamide | Anti-parkinson drugs | 207115 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Salbutamol sulfate | Drugs for obstructive airway diseases | 189577 | 2016-11 | 2017-11 | Issued Notice of Compliance |
| Sarilumab | Immunosuppressants | 191745 | 2016-03 | 2017-01 | Issued Notice of Compliance |
| Sebelipase alfa | Other alimentary tract and metabolism products | 204085 | 2017-04 | 2017-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Semaglutide | Drugs used in diabetes | 202059 | 2017-03 | 2018-01 | Issued Notice of Compliance |
| Semaglutide | Drugs used in diabetes | 226906 | 2019-06 | 2020-03 | Issued Notice of Compliance |
| Siponimod | Immunosuppressants | 223225 | 2019-02 | 2020-02 | Issued Notice of Compliance |
| Sirukumab | Immunosuppressants | 205568 | 2017-06 | 2017-10 | Cancelled by sponsor |
| Sodium chloride, sodium citrate | Blood substitutes and perfusion solutions | 225953 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Sodium zirconium cyclosilicate | All other therapeutic products | 218799 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir | Antivirals for systemic use | 190521 | 2016-01 | 2016-07 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir, voxilaprevir | Antivirals for systemic use | 202324 | 2017-02 | 2017-08 | Issued Notice of Compliance |
| Sotagliflozin | Drugs used in diabetes | 217853 | 2018-08 | 2019-06 | Cancelled by sponsor |
| Sucroferric oxyhydroxide | All other therapeutic products | 201492 | 2017-02 | 2018-01 | Issued Notice of Compliance |
| Sugammadex | All other therapeutic products | 180385 | 2015-04 | 2016-02 | Issued Notice of Compliance |
| Suvorexant | Psycholeptics | 196367 | 2016-08 | 2018-11 | Issued Notice of Compliance |
| Tacrolimus | Immunosuppressants | 209210 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Tafamidis meglumine | Other nervous system drugs | 228368 | 2019-07 | 2020-01 | Issued Notice of Compliance |
| Talazoparib | Antineoplastic agents | 220584 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Telotristat etiprate | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 208730 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Tenapanor | Drugs for constipation | 224850 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Tenofovir alafenamide hemifumarate | Antivirals for systemic use | 193066 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Teriparatide | Calcium homeostasis | 215409 | 2018-06 | 2020-01 | Issued Notice of Compliance |
| Tibolone | Sex hormones and modulators of the genital system | 206099 | 2017-10 | 2019-05 | Issued Notice of Compliance |
| Tipiracil hydrochloride, trifluridine | Antineoplastic agents | 205852 | 2017-07 | 2018-01 | Issued Notice of Compliance |
| Tisagenlecleucel-T | Antineoplastic agents | 213547 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Tisagenlecleucel-T | Antineoplastic agents | 213698 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 204579 | 2017-06 | 2019-05 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 212140 | 2018-02 | 2019-08 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 210238 | 2017-11 | 2019-09 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 208836 | 2017-10 | 2020-02 | Issued Notice of Compliance |
| Triamcinolone hexacetonide | Corticosteroids for systemic use | 201546 | 2017-02 | 2017-12 | Issued Notice of Compliance |
| Trifarotene | Anti-acne preparations | 221945 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Upadacitinib | Immunosuppressants | 223734 | 2019-03 | 2019-12 | Issued Notice of Compliance |
| Varicella-zoster virus glycoprotein E (GE) | Vaccines | 200244 | 2016-12 | 2017-10 | Issued Notice of Compliance |
| Venetoclax | Antineoplastic agents | 190761 | 2016-02 | 2016-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Vernakalant hydrochloride | Cardiac therapy | 190817 | 2016-05 | 2017-03 | Issued Notice of Compliance |
| Volanesorsen | Lipid modifying agents | 209280 | 2017-11 | 2018-11 | Issued Notice of Non-compliance - Withdrawal |
| Vonicog alfa | Antihemorrhagics | 213188 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Zofenopril calcium | Agents acting on the renin-angiotensin system | 212392 | 2018-06 | 2019-06 | Cancelled by sponsor |
|
|||||
| Medicinal Ingredient(s) | Therapeutic Area | Submission Control Number | Year, Month Submission was Accepted into Review | Year, Month Submission Concluded | Outcome of SubmissionFootnote a |
|---|---|---|---|---|---|
| Abacavir sulfate, dolutegravir sodium, lamivudine | Antivirals for systemic use | 208070 | 2017-08 | 2017-10 | Issued Notice of Compliance |
| Abatacept | Immunosuppressants | 204313 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Abiraterone acetate | Endocrine therapy | 207915 | 2017-08 | 2018-02 | Issued Notice of Compliance |
| AbobotulinumtoxinA | Muscle relaxants | 202245 | 2017-03 | 2017-12 | Issued Notice of Compliance |
| AbobotulinumtoxinA | Muscle relaxants | 204299 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| AbobotulinumtoxinA | Muscle relaxants | 206921 | 2017-08 | 2018-04 | Issued Notice of Compliance |
| Acalabrutinib | Antineoplastic agents | 231228 | 2019-10 | 2019-11 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 197529 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 201423 | 2017-02 | 2017-12 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 212133 | 2018-02 | 2018-11 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 213550 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Afatinib dimaleate | Antineoplastic agents | 209785 | 2017-12 | 2018-09 | Issued Notice of Compliance |
| Alectinib | Antineoplastic agents | 210816 | 2017-12 | 2018-06 | Issued Notice of Compliance |
| Alirocumab | Lipid modifying agents | 219669 | 2018-10 | 2019-07 | Issued Notice of Compliance |
| Alpha 1-proteinase inhibitor (human) | Antihemorrhagics | 205855 | 2017-06 | 2017-06 | Issued Notice of Compliance |
| Anakinra | Immunosuppressants | 195649 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 211971 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Apalutamide | Endocrine therapy | 228077 | 2019-06 | 2019-12 | Issued Notice of Compliance |
| Apixaban | Antithrombotic agents | 198842 | 2016-11 | 2018-10 | Issued Notice of Compliance |
| Aripiprazole | Psycholeptics | 200292 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Atezolizumab | Antineoplastic agents | 205038 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Atezolizumab | Antineoplastic agents | 217324 | 2018-07 | 2019-05 | Issued Notice of Compliance |
| Atezolizumab | Antineoplastic agents | 223753 | 2019-02 | 2019-08 | Issued Notice of Compliance |
| Atezolizumab | Antineoplastic agents | 223911 | 2019-02 | 2019-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Atezolizumab | Antineoplastic agents | 226905 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Avelumab | Antineoplastic agents | 225974 | 2019-04 | 2019-11 | Issued Notice of Compliance under the NOC/c Guidance |
| Azelastine hydrochloride, fluticasone propionate | Nasal preparations | 221498 | 2018-12 | 2019-10 | Issued Notice of Compliance |
| Bazedoxifene acetate, conjugated estrogens | Sex hormones and modulators of the genital system | 210469 | 2017-11 | 2018-09 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 207259 | 2017-08 | 2018-06 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 218844 | 2018-09 | 2019-06 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 230254 | 2019-09 | 2020-02 | Issued Notice of Compliance |
| Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 226658 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Blinatumomab | Antineoplastic agents | 197615 | 2016-09 | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Blinatumomab | Antineoplastic agents | 204154 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Blinatumomab | Antineoplastic agents | 210780 | 2017-12 | 2019-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Bosutinib | Antineoplastic agents | 211317 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Brentuximab vedotin | Antineoplastic agents | 213996 | 2018-04 | 2018-12 | Issued Notice of Compliance |
| Brentuximab vedotin | Antineoplastic agents | 216513 | 2018-07 | 2019-05 | Issued Notice of Compliance |
| Brentuximab vedotin | Antineoplastic agents | 227030 | 2019-05 | 2019-11 | Issued Notice of Compliance |
| Brexpiprazole | Psycholeptics | 205854 | 2017-07 | 2019-02 | Issued Notice of Compliance |
| Brivaracetam | Antiepileptics | 226734 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 218994 | 2018-09 | 2020-03 | Cancelled by sponsor |
| Budesonide, formoterol fumarate dihydrate | Drugs for obstructive airway diseases | 220998 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| C1 esterase inhibitor (human) | Other hematological agents | 197440 | 2016-09 | 2017-03 | Issued Notice of Compliance |
| Cabozantinib | Antineoplastic agents | 221859 | 2018-12 | 2019-10 | Issued Notice of Compliance |
| Cabozantinib | Antineoplastic agents | 222733 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Canagliflozin | Drugs used in diabetes | 194762 | 2016-06 | 2017-04 | Issued Notice of Compliance |
| Canagliflozin | Drugs used in diabetes | 210676 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Canagliflozin | Drugs used in diabetes | 229188 | 2019-08 | 2020-01 | Issued Notice of Compliance |
| Canagliflozin, metformin hydrochloride | Drugs used in diabetes | 210969 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Canakinumab | Immunosuppressants | 195617 | 2016-07 | 2017-01 | Issued Notice of Compliance |
| Carbetocin | Pituitary and hypothalamic hormones and analogues | 225949 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Ceftolozane, tazobactam sodium | Antibacterials for systemic use | 224729 | 2019-03 | 2019-08 | Issued Notice of Compliance |
| Certolizumab pegol | Immunosuppressants | 209082 | 2017-10 | 2018-08 | Issued Notice of Compliance |
| Certolizumab pegol | Immunosuppressants | 222049 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 195789 | 2016-08 | 2017-05 | Issued Notice of Compliance |
| Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 207251 | 2017-08 | 2018-06 | Issued Notice of Compliance |
| Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 219784 | 2018-10 | 2019-07 | Issued Notice of Compliance |
| Collagenase clostridium histolyticum | Other drugs for disorders of the musculo-skeletal system | 202488 | 2017-03 | 2018-01 | 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 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Crizotinib | Antineoplastic agents | 198322 | 2016-11 | 2017-08 | Issued Notice of Compliance |
| Dabrafenib | Antineoplastic agents | 199381 | 2016-11 | 2017-05 | Issued Notice of Compliance |
| Dabrafenib | Antineoplastic agents | 210753 | 2017-11 | 2018-05 | Issued Notice of Compliance |
| Dabrafenib | Antineoplastic agents | 213581 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Dapagliflozin | Drugs used in diabetes | 217312 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Dapagliflozin propanediol | Drugs used in diabetes | 227213 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Dapagliflozin, metformin hydrochloride | Drugs used in diabetes | 228055 | 2019-07 | 2020-04 | Issued Notice of Compliance |
| Daptomycin | Antibacterials for systemic use | 214792 | 2018-05 | 2019-02 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | 198647 | 2016-10 | 2017-04 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | 212559 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | 226512 | 2019-05 | 2019-10 | Issued Notice of Compliance |
| Denosumab | Drugs for treatment of bone diseases | 203717 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Denosumab | Drugs for treatment of bone diseases | 205235 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Dexlansoprazole | Drugs for acid related disorders | 215955 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Dimethyl fumarate | Other nervous system drugs | 213790 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Dolutegravir | Antivirals for systemic use | 207076 | 2017-08 | 2018-05 | Issued Notice of Compliance |
| Dulaglutide | Drugs used in diabetes | 201964 | 2017-03 | 2017-12 | Issued Notice of Compliance |
| Dupilumab | Other dermatological preparations | 221043 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Eculizumab | Immunosuppressants | 212987 | 2018-02 | 2018-08 | Issued Notice of Compliance |
| Eculizumab | Immunosuppressants | 225847 | 2019-04 | 2019-09 | Issued Notice of Compliance |
| Eltrombopag olamine | Antihemorrhagics | 195798 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Eltrombopag olamine | Antihemorrhagics | 216004 | 2018-07 | 2019-05 | Issued Notice of Compliance |
| Eltrombopag olamine | Antihemorrhagics | 217802 | 2018-06 | 2019-06 | Cancelled by sponsor |
| Emicizumab | Antihemorrhagics | 222209 | 2018-12 | 2019-06 | Issued Notice of Compliance |
| Empagliflozin | Drugs used in diabetes | 193840 | 2016-05 | 2018-04 | Issued Notice of Compliance |
| Empagliflozin | Drugs used in diabetes | 221628 | 2019-01 | 2019-04 | Issued Notice of Compliance |
| Empagliflozin, linagliptin | Drugs used in diabetes | 204589 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | 209807 | 2017-11 | 2018-09 | Issued Notice of Compliance |
| Enzalutamide | Endocrine therapy | 216719 | 2018-06 | 2018-12 | Issued Notice of Compliance |
| Eptacog alfa | Antihemorrhagics | 200866 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Eribulin mesylate | Antineoplastic agents | 197739 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Erlotinib hydrochloride | Antineoplastic agents | 194018 | 2016-06 | 2017-03 | Issued Notice of Compliance |
| Eslicarbazepine acetate | Antiepileptics | 208086 | 2017-09 | 2018-06 | Issued Notice of Compliance |
| Eslicarbazepine acetate | Antiepileptics | 209753 | 2017-11 | 2018-09 | Issued Notice of Compliance |
| Etanercept | Immunosuppressants | 193787 | 2016-05 | 2017-03 | Issued Notice of Compliance |
| Etanercept | Immunosuppressants | 213347 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Everolimus | Antineoplastic agents | 200814 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Evolocumab | Lipid modifying agents | 207038 | 2017-08 | 2018-06 | Issued Notice of Compliance |
| Evolocumab | Lipid modifying agents | 208904 | 2017-10 | 2018-08 | Issued Notice of Compliance |
| Exenatide | Drugs used in diabetes | 208034 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Fingolimod hydrochloride | Immunosuppressants | 215423 | 2018-05 | 2018-11 | Issued Notice of Compliance |
| Fluticasone furoate | Drugs for obstructive airway diseases | 208727 | 2017-10 | 2018-10 | Cancelled by sponsor |
| Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 215148 | 2018-05 | 2019-03 | Issued Notice of Compliance |
| Fulvestrant | Endocrine therapy | 201150 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Gadoterate meglumine | Contrast media | 205610 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Glecaprevir, pibrentasvir | Antivirals for systemic use | 222816 | 2018-12 | 2019-06 | Issued Notice of Compliance |
| Glycopyrronium bromide, indacaterol maleate | Drugs for obstructive airway diseases | 198552 | 2016-11 | 2017-08 | Issued Notice of Compliance |
| Golimumab | Immunosuppressants | 197362 | 2016-09 | 2017-06 | Issued Notice of Compliance |
| Golimumab | Immunosuppressants | 205724 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 199807 | 2016-11 | 2017-05 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 225528 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) | Vaccines | 218188 | 2018-08 | 2019-06 | Cancelled by sponsor |
| Hydromorphone hydrochloride | Analgesics | 223245 | 2019-01 | 2019-05 | Issued Notice of Compliance |
| Hydroxyethyl starch | Blood substitutes and perfusion solutions | 222938 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Hydroxyethyl starch | Blood substitutes and perfusion solutions | 223031 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Hydroxyurea | Antineoplastic agents | 226144 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Human immunoglobulin | Immune sera and immunoglobulins | 208033 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Ibrutinib | Immunosuppressants | 204436 | 2017-05 | 2017-10 | Issued Notice of Compliance |
| Ibrutinib | Antineoplastic agents | 212632 | 2018-02 | 2018-07 | Issued Notice of Compliance |
| Ibrutinib | Antineoplastic agents | 218457 | 2018-08 | 2019-02 | Issued Notice of Compliance |
| Ibrutinib | Antineoplastic agents | 222804 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Icatibant acetate | Other hematological agents | 217805 | 2018-09 | 2019-06 | Issued Notice of Compliance |
| Idelalisib | Antineoplastic agents | 203513 | 2017-04 | 2017-12 | Cancelled by sponsor |
| Immunoglobulin (human) | Immune sera and immunoglobulins | 201326 | 2017-01 | 2017-10 | Issued Notice of Compliance |
| Immunoglobulin (human) | Immune sera and immunoglobulins | 223557 | 2019-02 | 2019-11 | Cancelled by sponsor |
| IncobotulinumtoxinA | Muscle relaxants | 208713 | 2017-10 | 2019-06 | Issued Notice of Compliance |
| Infliximab | Immunosuppressants | 220321 | 2018-11 | 2019-08 | Issued Notice of Compliance |
| Insulin aspart | Drugs used in diabetes | 226586 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Insulin degludec | Drugs used in diabetes | 208917 | 2017-10 | 2018-07 | Issued Notice of Compliance |
| Insulin glargine | Drugs used in diabetes | 228382 | 2019-07 | 2020-05 | Issued Notice of Compliance |
| Ipilimumab | Antineoplastic agents | 202533 | 2017-02 | 2017-04 | Issued Notice of Compliance |
| Ivacaftor | Other respiratory system products | 218044 | 2018-08 | 2019-01 | Issued Notice of Compliance |
| Ivacaftor, lumacaftor | Other respiratory system products | 198036 | 2016-10 | 2017-04 | Issued Notice of Compliance |
| Ivacaftor, lumacaftor | Other respiratory system products | 215032 | 2018-06 | 2018-12 | Issued Notice of Compliance |
| Ixekizumab | Immunosuppressants | 204690 | 2017-06 | 2018-03 | Issued Notice of Compliance |
| Ixekizumab | Immunosuppressants | 225178 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Japanese encephalitis virus vaccine inactivated | Vaccines | 203520 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Lacosamide | Antiepileptics | 193732 | 2016-05 | 2017-02 | Issued Notice of Compliance |
| Lanreotide acetate | Pituitary and hypothalamic hormones and analogues | 203094 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Ledipasvir, sofosbuvir | Antivirals for systemic use | 199607 | 2016-12 | 2017-05 | Issued Notice of Compliance |
| Lenvatinib mesylate | Antineoplastic agents | 197794 | 2016-11 | 2017-09 | Issued Notice of Compliance |
| Lenvatinib mesylate | Antineoplastic agents | 212989 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Lenvatinib mesylate | Antineoplastic agents | 228723 | 2019-07 | 2019-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Leuprolide acetate | Endocrine therapy | 193372 | 2016-05 | 2017-02 | Issued Notice of Compliance |
| Levomilnacipran | Psychoanaleptics | 222857 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Levonorgestrel | Sex hormones and modulators of the genital system | 204355 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Linagliptin | Drugs used in diabetes | 194075 | 2016-06 | 2018-10 | Issued Notice of Compliance |
| Linagliptin | Drugs used in diabetes | 222572 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Linagliptin, metformin hydrochloride | Drugs used in diabetes | 194067 | 2016-06 | 2017-05 | Cancelled by sponsor |
| Liraglutide | Drugs used in diabetes | 196457 | 2016-08 | 2017-06 | Issued Notice of Compliance |
| Liraglutide | Drugs used in diabetes | 200821 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Liraglutide | Drugs used in diabetes | 225809 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Lurasidone hydrochloride | Psycholeptics | 197342 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Lurasidone hydrochloride | Psycholeptics | 205325 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Macitentan | Antihypertensives | 219599 | 2018-11 | 2019-11 | Cancelled by sponsor |
| Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid | Vaccines | 203844 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Mepolizumab | Drugs for obstructive airway diseases | 208467 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Mepolizumab | Drugs for obstructive airway diseases | 212242 | 2018-02 | 2018-10 | Cancelled by sponsor |
| Mepolizumab | Drugs for obstructive airway diseases | 221528 | 2018-12 | 2019-10 | Issued Notice of Compliance |
| Mepolizumab | Drugs for obstructive airway diseases | 226197 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Methylphenidate hydrochloride | Psychoanaleptics | 214860 | 2018-05 | 2019-03 | Issued Notice of Compliance |
| Methylphenidate hydrochloride | Psychoanaleptics | 224342 | 2019-03 | 2020-01 | Issued Notice of Compliance |
| Midostaurin | Antineoplastic agents | 210496 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Mifepristone, misoprostol | Sex hormones and modulators of the genital system | 200856 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Nadroparin calcium | Antithrombotic agents | 195973 | 2016-08 | 2017-07 | Issued Notice of Compliance |
| Naloxegol oxalate | Drugs for constipation | 221031 | 2018-11 | 2019-09 | Cancelled by sponsor |
| Nilotinib | Antineoplastic agents | 211052 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Nintedanib | Antineoplastic agents | 227166 | 2019-05 | 2019-11 | Issued Notice of Compliance |
| Nintedanib | Antineoplastic agents | 232923 | 2019-11 | 2020-05 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | 199379 | 2016-11 | 2017-05 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | 203286 | 2017-03 | 2017-11 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | 203593 | 2017-04 | 2018-01 | Cancelled by sponsor |
| Nivolumab | Antineoplastic agents | 206974 | 2017-07 | 2018-03 | Issued Notice of Compliance under the NOC/c Guidance |
| Nivolumab | Antineoplastic agents | 211838 | 2018-01 | 2018-07 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | 212067 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | 215535 | 2018-06 | 2019-11 | Cancelled by sponsor |
| Norfloxacin | Antibacterials for systemic use | 208906 | 2017-10 | 2017-12 | Issued Notice of Compliance |
| Obinutuzumab | Antineoplastic agents | 208089 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Olaparib | Antineoplastic agents | 210204 | 2017-11 | 2018-05 | Issued Notice of Compliance |
| Olaparib | Antineoplastic agents | 219799 | 2018-11 | 2019-05 | Issued Notice of Compliance |
| Olaparib | Antineoplastic agents | 230309 | 2019-08 | 2020-02 | Issued Notice of Compliance |
| Olodaterol hydrochloride, tiotropium bromide monohydrate | Drugs for obstructive airway diseases | 223910 | 2019-03 | 2019-12 | Issued Notice of Compliance |
| Omalizumab | Drugs for obstructive airway diseases | 194542 | 2016-06 | 2017-04 | Issued Notice of Compliance |
| Ombitasvir, paritaprevir, ritonavir | Antivirals for systemic use | 195504 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| OnabotulinumtoxinA | Muscle relaxants | 211053 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Osimertinib mesylate | Antineoplastic agents | 211762 | 2018-01 | 2018-07 | 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 | 2017-11 | 2018-08 | Issued Notice of Compliance |
| Palbociclib | Antineoplastic agents | 195948 | 2016-08 | 2017-05 | Issued Notice of Compliance |
| Palbociclib | Antineoplastic agents | 219500 | 2018-10 | 2019-08 | Issued Notice of Compliance |
| Palonosetron hydrochloride | Antiemetics and antinauseants | 215829 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Panitumumab | Antineoplastic agents | 193962 | 2016-06 | 2017-04 | Issued Notice of Compliance |
| Pasireotide | Pituitary and hypothalamic hormones and analogues | 209345 | 2017-11 | 2018-08 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 201200 | 2017-01 | 2017-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Pembrolizumab | Antineoplastic agents | 203157 | 2017-03 | 2017-09 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 209011 | 2018-01 | 2018-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Pembrolizumab | Antineoplastic agents | 212388 | 2018-05 | 2019-03 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 215699 | 2017-09 | 2019-04 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 216451 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 218779 | 2018-08 | 2019-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Pembrolizumab | Antineoplastic agents | 219700 | 2018-10 | 2019-07 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 228721 | 2019-07 | 2019-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Pembrolizumab | Antineoplastic agents | 223819 | 2019-02 | 2019-12 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | 219213 | 2018-09 | 2020-03 | Issued Notice of Compliance |
| Perampanel | Antiepileptics | 204327 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Perampanel | Antiepileptics | 225719 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Pertuzumab | Antineoplastic agents | 209467 | 2017-11 | 2018-08 | Issued Notice of Compliance |
| Pimecrolimus | Other dermatological preparations | 220947 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Plerixafor | Immunostimulants | 213345 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Pomalidomide | Immunosuppressants | 218459 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Ranibizumab | Ophthalmologicals | 201272 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Regorafenib | Antineoplastic agents | 203322 | 2017-04 | 2017-09 | Issued Notice of Compliance |
| Regorafenib | Antineoplastic agents | 214314 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Ribociclib succinate | Antineoplastic agents | 225074 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Rifaximin | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 209230 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 204718 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 228130 | 2019-07 | 2020-05 | Issued Notice of Compliance |
| Rivaroxaban | Antithrombotic agents | 211611 | 2018-01 | 2018-09 | Issued Notice of Compliance |
| Rufinamide | Antiepileptics | 194343 | 2016-06 | 2017-04 | Issued Notice of Compliance |
| Sarilumab | Immunosuppressants | 211993 | 2018-01 | 2019-08 | Issued Notice of Compliance |
| Secukinumab | Immunostimulants | 219231 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Semaglutide | Drugs used in diabetes | 227387 | 2019-06 | 2020-03 | Cancelled by sponsor |
| Sevelamer carbonate | All other therapeutic products | 211598 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Simeprevir | Antivirals for systemic use | 197253 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir | Antivirals for systemic use | 199753 | 2016-12 | 2017-09 | Issued Notice of Compliance |
| Somatropin | Pituitary and hypothalamic hormones and analogues | 205985 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Sunitinib malate | Antineoplastic agents | 208710 | 2017-10 | 2019-04 | Issued Notice of Non-compliance- Withdrawal |
| Teduglutide | Other alimentary tract and metabolism products | 223862 | 2019-02 | 2019-08 | Issued Notice of Compliance |
| Teriflunomide | Immunosuppressants | 221225 | 2018-12 | 2019-09 | Issued Notice of Compliance |
| Thioguanine | Antineoplastic agents | 199259 | 2016-11 | 2017-09 | Issued Notice of Compliance |
| Tinzaparin sodium | Antithrombotic agents | 199839 | 2016-12 | 2018-11 | Cancelled by sponsor |
| Tipiracil hydrochloride, trifluridine | Antineoplastic agents | 227070 | 2019-05 | 2019-11 | Issued Notice of Compliance |
| Tocilizumab | Immunosuppressants | 204251 | 2017-05 | 2017-10 | Issued Notice of Compliance |
| Tocilizumab | Immunosuppressants | 220039 | 2018-10 | 2019-08 | Issued Notice of Compliance |
| Tocilizumab | Immunosuppressants | 219690 | 2018-10 | 2019-07 | Issued Notice of Compliance |
| Tofacitinib | Immunosuppressants | 209522 | 2017-11 | 2018-09 | Issued Notice of Compliance |
| Tofacitinib | Immunosuppressants | 209643 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Tofacitinib | Immunosuppressants | 213578 | 2018-04 | 2019-01 | Issued Notice of Compliance |
| Tolvaptan | Diuretics | 213262 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Trametinib | Antineoplastic agents | 199382 | 2016-11 | 2017-05 | Issued Notice of Compliance |
| Trametinib | Antineoplastic agents | 210760 | 2017-11 | 2018-05 | Issued Notice of Compliance |
| Trametinib | Antineoplastic agents | 213580 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Trastuzumab emtansine | Antineoplastic agents | 227372 | 2019-05 | 2019-11 | Issued Notice of Compliance |
| Ustekinumab | Immunosuppressants | 224739 | 2019-03 | 2020-01 | Issued Notice of Compliance |
| Venetoclax | Antineoplastic agents | 214078 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Venetoclax | Antineoplastic agents | 228475 | 2019-07 | 2020-04 | Issued Notice of Compliance |
| Vilazodone hydrochloride | Psychoanaleptics | 210066 | 2017-11 | 2018-10 | Cancelled by sponsor |
| Vortioxetine hydrobromide | Psychoanaleptics | 212548 | 2018-02 | 2018-12 | Issued Notice of Compliance |
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