Drug and Health Product Submissions Under Review (SUR)

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

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About the Submissions Under Review (SUR) Lists

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

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

The lists have been implemented in phases. 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.

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 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)
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

Alpelisib Antineoplastic agents 2019-05 Novartis Pharmaceuticals Canada Inc New active substance
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
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
Betula Verrucosa Extract Nasal preparations 2019-06 ALK - Abello A/S Not applicable
Bevacizumab Antineoplastic agents 2018-08 Not available Not available
Bivalirudin Antithrombotic agents 2019-11 Avir Pharma Inc Not applicable
Brolucizumab Ophthalmologicals 2019-05 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 2019-06 Bausch Health, Canada Inc. Not applicable
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
Cabotegravir, rilpivirine Antivirals for systemic use 2019-05 ViiV Healthcare ULC

New active substance

Part of 'aligned review' with a health technology assessment organization

Caffeine citrate Psychoanaleptics 2019-05 Chiesi Farmaceutici S.p.A. Being reviewed under the Submissions Relying on Third-Party Data Guidance
Cedazuridine, decitabine Antineoplastic agents 2020-01 Otsuka Pharmaceutical Co Ltd 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 2019-06 Fresenius Kabi Canada Ltd Being reviewed under the Submissions Relying on Third-Party Data Guidance
Dequalinium chloride Gynecological antiinfectives and antiseptics 2019-07 Duchesnay Inc Not applicable
Dermatophagoides farinae, dermatophagoides pteronyssinus Allergens 2017-09 Not available Not available
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
Entrectinib Antineoplastic agents 2019-07 Hoffmann La Roche Limited Not applicable
Esketamine hydrochloride Psychoanaleptics 2019-01 Janssen Inc

Being reviewed under the Priority Review Policy

Part of 'aligned review' with a health technology assessment organization

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

Etonogestrel Sex hormones and modulators of the genital system 2019-05 Merck Canada Inc Not applicable
Fedratinib dihydrochloride monohydrate Antineoplastic agents 2019-10 Celgene Inc

New active substance

Part of 'aligned review' with a health technology assessment organization

Filgrastim (r-metHuG-CSF) Immunostimulants 2018-04 Not available Not available
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
Fremanezumab Analgesics 2019-06 Teva Canada Limited 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
Glasdegib Antineoplastic agents 2019-07 Pfizer Canada ULC New active substance
Glycopyrronium bromide, indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 2019-09 Novartis Pharmaceuticals Canada Inc Not applicable
Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations 2018-05 Not available Not available
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 2020-01 Seqirus UK Limited Not applicable
Indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 2019-07 Novartis Pharmaceuticals Canada Inc Not applicable
Infliximab Immunosuppressants 2019-05 Amgen Canada Inc

Biosimilar

Part of 'aligned review' with a health technology assessment organization

Insulin aspart Drugs used in diabetes 2019-12 Sanofi-Aventis Canada Inc Biosimilar
Isatuximab Antineoplastic agents 2019-07 Sanofi-Aventis 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

Being reviewed under the Priority Review Policy

Levothyroxine sodium Thyroid therapy 2020-01 IBSA Institut Biochimique SA Being reviewed under the Submissions Relying on Third-Party Data Guidance
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
Nicardipine hydrochloride Calcium channel blockers 2018-07 Not available Not available
Obiltoxaximab Immune sera and immunoglobulins 2018-10 Elusys Therapeutics Inc

Extraordinary use submission

New active substance

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 2019-05 Sandoz Canada Incorporated Biosimilar
Pegfilgrastim Immunostimulants 2019-11 Purdue Pharma Biosimilar
Pegfilgrastim Immunostimulants 2020-01 Pfizer Canada ULC Biosimilar
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
Risperidone Psycholeptics 2020-01 HLS Therapeutics Inc Not applicable
Rituximab Antineoplastic agents 2018-04 Not available Not available
Rituximab Antineoplastic agents 2019-03 Pfizer Canada ULC Biosimilar
Satralizumab Immunosuppressants 2019-12 Hoffmann La Roche Limited

New active substance

Being reviewed under the Priority Review Policy

Semaglutide Drugs used in diabetes 2019-06 Novo Nordisk Canada Inc Not applicable
Sodium chloride, sodium citrate Blood substitutes and perfusion solutions 2019-05 Baxter Corporation Being reviewed under the Submissions Relying on Third-Party Data Guidance
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

Tenapanor Drugs for constipation 2019-06 Knight Therapeutics Inc. New active substance
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
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
Submissions currently 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)
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
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 2019-06 Hoffmann La Roche Limited Not applicable
Atezolizumab Antineoplastic agents 2020-02 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
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 2019-05 Gilead Sciences Canada Inc Not applicable
Brivaracetam Antiepileptics 2019-05 UCB Canada Inc Not applicable
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2018-09 Not available Not available
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
Carglumic acid Other alimentary tract and metabolism products 2019-06 Recordati Rare Diseases Being reviewed under the Priority Review Policy
Dapagliflozin, metformin hydrochloride Drugs used in diabetes 2019-07 AstraZeneca Canada Inc Not applicable
Dapagliflozin propanediol Drugs used in diabetes 2019-06 AstraZeneca Canada Inc Not applicable
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), pertactin, pertussis toxoid, tetanus toxoid Vaccines 2018-11 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 2018-11 Sanofi Pasteur Limited 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
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
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 Drugs used in diabetes 2019-07 Sanofi-Aventis 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
Macitentan Antihypertensives 2019-01 Janssen Inc Not applicable
Mepolizumab Drugs for obstructive airway diseases 2019-05 GlaxoSmithKline Inc Not applicable
Nintedanib Antineoplastic agents 2019-11 Boehringer Ingelheim (Canada) Ltd Ltee Being reviewed under the Priority Review Policy
Nivolumab Antineoplastic agents 2020-01 Bristol-Myers Squibb Canada Not applicable
Olaparib Antineoplastic agents 2020-02 AstraZeneca Canada Inc Being reviewed under the Priority Review Policy
Pembrolizumab Antineoplastic agents 2018-09 Not available Not available
Pembrolizumab Antineoplastic agents 2019-12 Merck Canada Inc Not applicable
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
Rituximab Antineoplastic agents 2019-07 Celltrion Healthcare Co Ltd Biosimilar
Rivaroxaban Antithrombotic agents 2020-02 Bayer Inc Not applicable
Semaglutide Drugs used in diabetes 2019-06 Novo Nordisk 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
Umeclidinium bromide Drugs for obstructive airway diseases 2019-01 GlaxoSmithKline Inc Not applicable
Ustekinumab Immunosuppressants 2019-08 Janssen Inc Not applicable
Venetoclax Antineoplastic agents 2019-07 AbbVie Corporation Not applicable
Submissions formerly under review: New drug submissions
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
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
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
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 227232 2019-05 2019-11 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
Cabozantinib Antineoplastic agents 206230 2017-07 2018-09 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
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
Cyclosporin Ophthalmologicals 194580 2016-08 2018-04 Issued Notice of Non-compliance- Withdrawal
Cyclosporin 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, lamivudine Antivirals for systemic use 220275 2018-10 2019-08 Issued Notice of Compliance
Dolutegravir sodium, rilpivirine hydrochloride Antivirals for systemic use 206402 2017-07 2018-05 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
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
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
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
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
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
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
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
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
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
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
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
Siponimod Immunosuppressants 223225 2019-02 2020-02 Issued Notice of Compliance
Sirukumab Immunosuppressants 205568 2017-06 2017-10 Cancelled by sponsor
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
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
Footnote 1

For more information about Notices of Compliance issued under the NOC/c Guidance, including whether conditions have been met, please visit "Notice of Compliance with conditions (NOC/c)".

Return to footnote a referrer

https://canada-preview.adobecqms.net/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/notice.html
Submissions formerly under review: Supplemental new drug submissions for new uses
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
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
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
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
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 January 20202 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
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 age 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
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
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
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
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
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
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
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
Vilazodone hydrochloride Psychoanaleptics 210066 2017-11 2018-10 Cancelled by sponsor
Vortioxetine hydrobromide Psychoanaleptics 212548 2018-02 2018-12 Issued Notice of Compliance
Footnote 1

For more information about Notices of Compliance issued under the NOC/c Guidance, including whether conditions have been met, please visit "Notice of Compliance with conditions (NOC/c)".

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