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.

Consult the Drug and vaccine authorizations for COVID-19: List of applications received to access submissions under review that are related to the COVID-19 pandemic.

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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 2020-03 Pfizer Canada ULC Biosimilar
Amisulfide Psycholeptics 2020-03 KYE Pharmaceuticals Inc New active substance

Being reviewed under the Submissions Relying on Third-Party Data Guidance
Avanafil Urologicals 2019-06 Acerus Pharmaceuticals Corporation New active substance
Azacitidine Antineoplastic agents 2020-07 Celgene Inc Being reviewed under the Priority Review Policy
Bacillus Calmette-Guerin BCG Immunostimulants 2018-12 Verity Pharmaceuticals Inc Not applicable
Bevacizumab Antineoplastic agents 2018-08 Not available Not available
Bevacizumab Antineoplastic agents 2020-07 BGP Pharma ULC Biosimilar
Bevacizumab Antineoplastic agents 2020-10 Centus Biotherapeutics Limited Biosimilar
Binimetinib Antineoplastic agents 2020-05 Pfizer Canada ULC New active substance

Part of 'aligned review' with a health technology assessment organization
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
Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 2020-09 AstraZeneca 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
Cevimeline hydrochloride Other nervous system drugs 2020-09 KYE Pharmaceuticals Inc New active substance
Chlormethine Antineoplastic agents 2020-08 Recordati Rare Diseases Canada Inc Not applicable
Cyclosporine Ophthalmologicals 2020-04 Sun Pharma Global FZE Not applicable
Dequalinium chloride Gynecological antiinfectives and antiseptics 2019-07 Duchesnay Inc Not applicable
Diroximel fumarate Immunosuppressants 2020-07 Biogen Canada Inc New active substance
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
Encorafenib Antineoplastic agents 2020-06 Pfizer Canada ULC 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 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
Etanercept Immunosuppressants 2020-02 Lupin Pharma Canada Limited Biosimilar
Ferric pyrophosphate citrate Antianemic preparations 2020-06 Rockwell Medical Inc Not applicable
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
Fostamatinib disodium Antihemorrhagics 2020-01 Rigel Pharmaceuticals Inc. New active substance
Ganciclovir Ophthalmologicals 2019-02 Laboratoires Thea Not applicable
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
Goserelin acetate Endocrine therapy 2020-07 JAMP Pharma Corporation 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
Idecabtagene vicleucel Antineoplastic agents 2020-10 Celgene Inc New active substance

Being reviewed under the Priority Review Policy
Inclisiran sodium Lipid modifying agents 2020-09 Novartis Pharmaceuticals Canada Inc New active substance
Lasmiditan Analgesics 2020-04 Eli Lilly Canada Inc New active substance
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 2020-04 Celgene Inc Not applicable
Mecasermin Pituitary, hypothalamic hormones and analogues 2020-02 Ipsen Biopharmaceuticals Canada Inc New active substance
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2016-09 Not available Not available
Methylene blue Diagnostic agents 2018-10 Pendopharm Division of Pharmascience Inc Not applicable
Mometasone furoate monohydrate, olopatadine hydrochloride Nasal preparations 2020-07 Glenmark Specialty SA Not applicable
Ofatumumab Antineoplastic agents 2020-05 Novartis Pharmaceuticals Canada Inc Part of 'aligned review' with a health technology assessment organization
Onasemnogene abeparvovec Other drugs for disorders of the musculo-skeletal system 2020-06 Novartis Pharmaceuticals Canada Inc New active substance

Being reviewed under the Priority Review Policy

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
Pegfilgrastim Immunostimulants 2019-11 Purdue Pharma Biosimilar
Pemigatinib Antineoplastic agents 2020-10 Incyte Corporation New active substance
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
Ponesimod Immunosuppressants 2020-07 Janssen Inc New active substance
Progesterone Sex hormones and modulators of the genital system 2020-07 IBSA Institut Biochimique SA Not applicable
Ranolazine Cardiac therapy 2020-07 KYE Pharmaceuticals Inc New active substance

Being reviewed under the Priority Review Policy
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
Risdiplam Other drugs for disorders of the musculo-skeletal system 2020-10 Hoffmann La Roche Limited 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
Selpercatinib Antineoplastic agents 2020-10 Loxo Oncology Inc New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Part of 'aligned review' with a health technology assessment organization
Sodium pertechnetate Tc-99m Diagnostic radiopharmaceuticals 2020-01 BC Cancer, Part of the Provincial Health Services Authority Not applicable
Solriamfetol hydrochloride Psychoanaleptics 2020-07 Jazz Pharmaceuticals Ireland Limited New active substance
Tafamidis Other nervous system drugs 2020-09 Pfizer Canada ULC Not applicable
Tazarotene Antipsoriatics 2020-09 Bausch Health, Canada Inc. Not applicable
Tepotinib Antineoplastic agents 2020-10 EMD Serono a Division of EMD Inc Canada New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance
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 Antineoplastic agents 2020-04 Samsung Bioepis Co., Ltd Biosimilar
Trastuzumab
(2 submissions under review)
Antineoplastic agents 2017-11 Not available Not available
Trastuzumab deruxtecan Antineoplastic agents 2020-08 AstraZeneca Canada Inc

New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Part of 'aligned review' with a health technology assessment organization
Treosulfan Antineoplastic agents 2020-01 Marcan Pharmaceuticals Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Trientine hydrochloride All other therapeutic products 2020-06 Waymade PLC New active substance

Being reviewed under the Submissions Relying on Third-Party Data Guidance
Triheptanoin Other alimentary tract and metabolism 2020-08 Ultragenyx Pharmaceutical 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
Zanubrutinib Antineoplastic agents 2020-09 Beigene Switzerland GMBH New active substance

Being reviewed under the Priority Review Policy
Zanubrutinib Antineoplastic agents 2020-09 Beigene Switzerland GMBH Not applicable
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)
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
Adalimumab Immunosuppressants 2020-06 AbbVie Corporation Not applicable
Alemtuzumab Immunosuppressants 2020-07 Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc Not applicable
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
Atezolizumab Antineoplastic agents 2020-05 Hoffmann La Roche Limited Not applicable
Avelumab Antineoplastic agents 2020-06 EMD Serono a Division of EMD Inc Canada Being reviewed under the Priority Review Policy
Belimumab Immunosuppressants 2020-10 GlaxoSmithKline Inc Not applicable
Bevacizumab Antineoplastic agents 2019-11 Amgen Canada Inc Biosimilar
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 2020-07 Gilead Sciences Canada Inc Not applicable
Bilastine Antihistamines for systemic use 2020-10 Aralez Pharmaceuticals Canada Inc Not applicable
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
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
Crisaborole Other dermatological preparations 2020-07 Pfizer Canada ULC Not applicable
Daratumumab Antineoplastic agents 2020-01 Janssen Inc Not applicable
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 2020-09 ALK - Abello A/S Not applicable
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, inactivated poliovirus type I, inactivated poliovirus type II, inactivated poliovirus type III, pertactin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed Vaccines 2020-10 GlaxoSmithKline Inc Not applicable
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed Vaccines 2020-10 GlaxoSmithKline Inc Not applicable
Dolutegravir Antivirals for systemic use 2020-04 ViiV Healthcare ULC 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
Emtricitabine, tenofovir alafenamide Antivirals for systemic use 2020-02 Gilead Sciences Canada Inc Not applicable
Etanercept Immunosuppressants 2019-05 Sandoz Canada Incorporated Biosimilar
Fibrinogen (human) Antihemorrhagics 2019-06 CSL Behring Canada Inc Not applicable
Flibanserin Other gynecologicals 2019-07 Sprout Pharmaceuticals Canada, Ltd Not applicable
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 2020-07 GlaxoSmithKline Inc Not applicable
Formoterol fumarate dihydrate, mometasone furoate Drugs for obstructive airway diseases 2020-06 Merck Canada Inc 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
Immunoglobulin (human) Immune sera and immunoglobulins 2020-07 Octapharma Pharmazeutika Produktionsges M B H 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
Isatuximab Antineoplastic agents 2020-10 Sanofi-Aventis Canada Inc Not applicable
Ixekizumab Immunosuppressants 2020-06 Eli Lilly Canada Inc Not applicable
Liraglutide Drugs used in diabetes 2020-05 Novo Nordisk Canada Inc Not applicable
Neratinib maleate Antineoplastic agents 2020-09 Knight Therapeutics Inc Not applicable
Nintedanib Antineoplastic agents 2020-08 Boehringer Ingelheim (Canada) Ltd Ltee Not applicable
Nivolumab Antineoplastic agents 2020-01 Bristol-Myers Squibb Canada Not applicable
Nivolumab Antineoplastic agents 2020-06 Bristol-Myers Squibb Canada Being reviewed under the Notice of Compliance with Conditions Guidance
Nivolumab Antineoplastic agents 2020-09 Bristol-Myers Squibb Canada Not applicable
Omalizumab Drugs for obstructive airway diseases 2020-08 Novartis Pharmaceuticals Canada Inc Not applicable
OnabotulinumtoxinA Muscle relaxants 2020-05 Allergan Inc Not applicable
Osimertinib mesylate Antineoplastic agents 2020-09 AstraZeneca Canada Inc Being reviewed under the Priority Review Policy
Pembrolizumab Antineoplastic agents 2020-04 Merck Canada Inc Being reviewed under the Notice of Compliance with Conditions Guidance
Pembrolizumab Antineoplastic agents 2020-07 Merck Canada Inc Not applicable
Ranibizumab Opthalmologicals 2019-11 Novartis Pharmaceuticals Canada Inc Not applicable
Rituximab Antineoplastic agents 2020-09 Sandoz Canada Incorporated Biosimilar
Rivaroxaban Antithrombotic agents 2020-02 Bayer Inc Not applicable
Rivaroxaban Antithrombotic agents 2020-03 Bayer Inc Not applicable
Romiplostim Antihemorrhagics 2020-10 Amgen Canada Inc Not applicable
Secukinumab Immunosuppressants 2020-03 Novartis Pharmaceuticals Canada Inc Not applicable
Secukinumab Immunosuppressants 2020-07 Novartis Pharmaceuticals Canada Inc Not applicable
Sofosbuvir, velpatasvir Antivirals for systemic use 2020-01 Gilead Sciences Canada Inc Not applicable
Somatropin Pituitary and hypothalamic hormones and analogues 2020-08 Novo Nordisk Canada Inc 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
Trastuzumab Antineoplastic agents 2020-05 Celltrion Healthcare Co Ltd Biosimilar
Trastuzumab Antineoplastic agents 2020-06 Amgen Canada Inc Biosimilar

Part of an 'aligned review' with a health technology assessment organization
Trastuzumab Antineoplastic agents 2020-09 Pfizer Canada ULC Biosimilar
Tretinoin Anti-acne preparations 2020-03 Bausch Health, Canada Inc. Not applicable
Upadacitinib Immunosuppressants 2020-08 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
5-Aminolevulinic acid Antineoplastic agents 234673 2020-03 2020-09 Issued Notice of Compliance
Abemaciclib Antineoplastic agents 215268 2018-06 2019-04 Issued Notice of Compliance
Acalabrutinib Antineoplastic agents 214504 2018-04 2019-08 Issued Notice of Compliance
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
Adalimumab Immunosuppressants 230637 2019-10 2020-10 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
Amifampridine Other nervous system drugs 234655 2020-02 2020-08 Issued Notice of Compliance
Amifampridine phosphate Other nervous system drugs 232685 2020-02 2020-07 Issued Notice of Compliance
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-domaintruncated), pegylated Antihemorrhagics 218531 2018-09 2019-07 Issued Notice of Compliance
Apalutamide Endocrine therapy 211942 2018-01 2018-07 Issued Notice of Compliance
Apomorphine hydrochloride Anti-parkinson drugs 217320 2018-08 2020-06 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 alafenamidehemifumarate 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
Bisoprolol fumarate Beta blocking agents 231842 2020-05 2020-09 Cancelled by sponsor
Bivalirudin Antithrombotic agents 232423 2019-11 2020-09 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-infectiveagents 227232 2019-05 2019-11 Issued Notice of Compliance
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infectiveagents 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 2020-03 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
Cedazuridine, decitabine Antineoplastic agents 234610 2020-01 2020-07 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 2018-11 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, tenofoviralafenamide 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, dermatophagoides pteronyssinus Allergens 208152 2017-09 2020-07 Cancelled by sponsor
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, sodiumphosphate 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
Enoxaparin sodium Antithrombotic agents 233058 2019-12 2020-10 Issued Notice of Compliance
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
Estradiol hemihydrate, progesterone Sex hormones and modulators of the genital system 224010 2019-11 2020-09 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
Etomidate Anesthetics 231245 2019-12 2020-07 Issued Notice of Compliance
Etonogestrel Sex hormones and modulators of the genital system 226314 2019-05 2020-05 Issued Notice of Compliance
Fedratinib dihydrochloride monohydrate Antineoplastic agents 229866 2019-10 2020-07 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, vilanteroltrifenatate 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
Foscarnet sodium Antivirals for systemic use 233046 2019-12 2020-10 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
Gallium (68Ga) chloride, germanium (68Ge) chloride Diagnostic radiopharmaceuticals 227804 2019-10 2020-08 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
Givosiran Bile and liver therapy 237194 2020-04 2020-10 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
Glycopyrronium bromide, indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 228353 2019-09 2020-07 Issued Notice of Compliance
Guselkumab Immunosuppressants 200590 2017-01 2017-11 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strainA(H3N2), haemagglutinin-strain B Vaccines 200726 2017-05 2019-03 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strainA(H3N2), haemagglutinin-strain B(Victoria),haemagglutinin-strain B(Yamagata) Vaccines 203436 2017-04 2018-02 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strainA(H3N2), haemagglutinin-strain B(Victoria),haemagglutinin-strain B(Yamagata) Vaccines 222669 2019-01 2019-11 Issued Notice of Compliance
Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations 212718 2018-05 2020-06 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 aspart Drugs used in diabetes 226573 2019-12 2020-10 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
Lefamulin acetate Antibacterials for systemic use 233292 2020-01 2020-07 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
Luspatercept Antianemic preparations 236441 2020-03 2020-09 Issued Notice of Compliance
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
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 233632 2020-01 2020-10 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-infectiveagents 204605 2017-05 2018-03 Issued Notice of Compliance
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 198475 2017-02 2020-08 Cancelled by sponsor
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 lipidatedprotein 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 2016-07 2016-12 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 193770 2016-05 2016-11 Issued Notice of Compliance
Nusinersen Other drugs for disorders of the musculo-skeletalsystemOther 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
Obiltoxaximab Immune sera and immunoglobulins 230825 2019-10 2020-07 Issued Notice of Compliance
Ocrelizumab Immunosuppressants 198094 2016-10 2017-08 Issued Notice of Compliance
Ocrelizumab Immunosuppressants 197969 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 2016-11 2018-07 Cancelled by sponsor
Ozanimod hydrochloride Immunosuppressants 232761 2019-12 2020-10 Issued Notice of Compliance
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
Pegfilgrastim Immunostimulants 233373 2020-01 2020-10 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
Polatuzumab vedotin Antineoplastic agents 232303 2019-11 2020-07 Issued Notice of Compliance under the NOC/c Guidance
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 withrecombinant albumin (RIX-FP) Antihemorrhagics 180793 2015-04 2016-01 Issued Notice of Compliance
Remdesivir Antivirals for systemic use 240551 2020-07 2020-07 Issued Notice of Compliance under the NOC/c Guidance
Reslizumab Immunosuppressants 185873 2015-09 2016-07 Issued Notice of Compliance
Ribociclib Antineoplastic agents 203884 2017-05 2018-03 Issued Notice of Compliance
Ripretinib Antineoplastic agents 234688 2020-03 2020-06 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
Satralizumab Immunosuppressants 233642 2019-12 2020-06 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
Sonidegib Antineoplastic agents 229407 2019-08 2020-06 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-infectiveagents 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
Trientine hydrochloride Other alimentary tract and metabolism products 228708 2019-11 2020-09 Issued Notice of Compliance
Trifarotene Anti-acne preparations 221945 2019-01 2019-11 Issued Notice of Compliance
Tucatinib Antineoplastic agents 235295 2020-02 2020-06 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
Voretigene neparvovec Ophthalmologicals 233097 2019-12 2020-10 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

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
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
Apremilast Immunosuppressants 233030 2019-12 2020-08 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
Atezolizumab Antineoplastic agents 235450 2020-02 2020-08 Issued Notice of Compliance
Avelumab Antineoplastic agents 225974 2019-04 2019-11 Issued Notice of Compliance under the NOC/c Guidance
Avelumab Antineoplastic agents 226954 2019-06 2020-06 Cancelled by sponsor
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
Burosumab Drugs for the treatment of bone diseases 229313 2019-08 2020-06 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
Canagliflozin, metformin hydrochloride Drugs used in diabetes 232307 2019-11 2020-08 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 2016-07 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 propanediol Drugs used in diabetes 234304 2020-01 2020-06 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
Diphtheria toxoid, filamentous haemagglutinin, 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 220233 2018-11 2020-09 Issued Notice of Compliance
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid Vaccines 220103 2018-11 2020-09 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
Dulaglutide Drugs used in diabetes 232128 2019-11 2020-09 Issued Notice of Compliance
Dupilumab Other dermatological preparations 221043 2018-11 2019-09 Issued Notice of Compliance
Dupilumab Other dermatological preparations 231268 2019-10 2020-08 Issued Notice of Compliance
Durvalumab Antineoplastic agents 233107 2019-11 2020-09 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 2018-06 2019-06 Cancelled by sponsor
Eltrombopag olamine Antihemorrhagics 217802 2018-07 2019-05 Issued Notice of Compliance
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
Enzalutamide Endocrine therapy 233563 2019-12 2020-06 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
Etanercept Immunosuppressants 231313 2019-10 2020-08 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
Fibrinogen (human) Antihemorrhagics 230407 2019-09 2020-07 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
Galcanezumab Analgesics 232324 2019-11 2020-09 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
Guselkumab Immunosuppressants 232124 2019-11 2020-09 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
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 229325 2019-08 2020-06 Issued Notice of Compliance
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
Insulin glargine, lixisenatide Drugs used in diabetes 232504 2019-11 2020-09 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
Ixekizumab Immunosuppressants 233071 2019-12 2020-10 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 2016-11 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
Linagliptin, metformin hydrochloride Drugs used in diabetes 229225 2019-08 2020-06 Issued Notice of Compliance
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
Macitentan Antihypertensives 221389 2019-01 2020-07 Issued Notice of Compliance
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
Niraparib Antineoplastic agents 237670 2020-04 2020-10 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 212067 2018-01 2018-07 Issued Notice of Compliance
Nivolumab Antineoplastic agents 211838 2018-01 2018-11 Issued Notice of Compliance
Nivolumab Antineoplastic agents 215535 2018-06 2019-11 Cancelled by sponsor
Nivolumab Antineoplastic agents 236255 2020-03 2020-08 Issued Notice of Compliance
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
Olaparib Antineoplastic agents 235698 2020-02 2020-08 Issued Notice of Compliance
Olodaterol hydrochloride, tiotropium bromide monohydrate Drugs for obstructive airway diseases 223910 2019-03 2020-08 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
Onabotulinumtoxin 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 2016-07 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 212388 2018-01 2018-09 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 215699 2018-05 2019-03 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 209011 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
Pembrolizumab Antineoplastic agents 232775 2019-12 2020-10 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
Pertuzumab, trastuzumab Antineoplastic agents 222022 2018-12 2020-07 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
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein Vaccines 223244 2019-02 2020-08 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
Ribociclib succinate Antineoplastic agents 233623 2019-12 2020-10 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
Semaglutide Drugs used in diabetes 231580 2019-10 2020-08 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
Somatropin R-DNA origin Pituitary and hypothalamic hormones and analogues 229726 2019-08 2020-06 Issued Notice of Compliance
Sulfur hexafluoride Contrast media 231944 2019-11 2020-08 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
Teriflunomide Immunosuppressants 231739 2019-11 2020-09 Issued Notice of Compliance
Thioguanine Antineoplastic agents 199259 2016-11 2017-09 Issued Notice of Compliance
Ticagrelor Antithrombotic agents 231818 2019-10 2020-08 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
Umeclidinium bromide Drugs for obstructive airway diseases 222505 2019-01 2020-09 Issued Notice of Compliance
Ustekinumab Immunosuppressants 224739 2019-03 2020-01 Issued Notice of Compliance
Ustekinumab Immunosuppressants 230279 2019-08 2020-06 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
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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