Drug and health product submissions under review (SUR)
How to access lists of drug submissions currently under review, and lists of certain drug submissions formerly under review.
On this page
About the Submissions Under Review (SUR) Lists
The Submissions Under Review (SUR) Lists help to make our review processes more transparent. The lists will help Canadians:
- make better decisions about their health
- identify substances accepted for review in Canada
The lists have been implemented in phases. You can find more information about the phased approach in the Notices published in April 2016 (Phase I and II) and August 2018 (Phase III).
The Submissions Under Review (SUR) Lists include new drug submissions containing new active substances (pharmaceuticals and biologics with an active ingredient not approved in Canada). This applies to submissions accepted for review on or after April 1, 2015.
The lists also include submissions accepted for review on or after May 1, 2016, specifically:
- new drug submissions
- supplemental new drug submissions for new uses
A separate list is published for generic submissions (abbreviated new drug submissions) accepted into review on or after October 1, 2018. Click here to see the Generic Submissions Under Review (GSUR) List.
Finding information on the lists
There are four Submissions Under Review (SUR) Lists, which contain:
- new drug submissions currently under review
- supplemental new drug submissions currently under review
- new drug submissions formerly under review
- supplemental new drug submissions formerly under review
All four lists are updated monthly. A substance is moved from the list of submissions currently under review to the list of submissions formerly under review when it reaches a conclusion (it is cancelled, or a final decision is made).
Lists of submissions currently under review
The entry for each submission on the lists of submissions currently under review includes the:
- medicinal ingredient(s)
- month and year the submission was accepted into review
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
For submissions accepted into review on or after October 1, 2018, the following information will be added to the lists of submissions currently under review:
- company name
- ‘class’ of the submission
The submission ‘class’ includes whether the submission is for a new active substance or a biosimilar, if it is being reviewed as per a formal expedited process, if review is taking place as part of an aligned process with a health technology assessment organization, and more. More information can be found here.
Lists of submissions formerly under review
Each entry for each submission on the lists of submissions formerly under review includes the:
- medicinal ingredient(s)
- month and year the submission was accepted into review
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
- month and year the submission concluded
- hyperlink to the regulatory decision summary or summary of cancellation
Decisions
A substance is removed from the submissions currently under review list and added to the submissions formerly under review list when:
- the submission is cancelled or
- a final decision is made and the submission is no longer under review
You can see if a submission has been approved in the Notice of Compliance Database.
Information about decisions (positive or negative) and cancellations can be found in the Regulatory Decision Summary. If applicable, a more detailed explanation is available in a Summary Basis of Decision document.
External Consultations
Several external consultations have been held as the SUR List initiative has evolved. In 2017, an external consultation was held on five transparency proposals for prescription drugs. This report provides a summary of the consultation results.
The purpose of this report is to provide a summary of the results of the on-line questionnaire posted in 2016. The subject of the questionnaire was health product transparency initiatives.
View the lists
You can view the drug and health product submission lists any time. The four lists are:
| Medicinal Ingredient(s) | Therapeutic Area | Month, Year Submission was Accepted into Review | Company Name* | Submission ‘Class’* |
|---|---|---|---|---|
| Abemaciclib | Antineoplastic agents | June 2018 | ||
| Acalabrutinib | Antineoplastic agents | April 2018 | ||
| Adalimumab | Immunosuppressants | November 2018 | Sandoz Canada Incorporated | Biosimilar |
| Apomorphine hydrochloride | Anti-parkinson drugs | August 2018 | ||
| Ataluren | Other drugs for disorders of the musculo-skeletal system | September 2018 | ||
| Bacillus Calmette-Guerin BCG | Immunostimulants | December 2018 | Verity Pharmaceuticals Inc | |
| Belinostat | Antineoplastic agents | December 2017 | ||
| Bevacizumab | Antineoplastic agents | August 2018 | ||
| Bevacizumab | Antineoplastic agents | August 2018 | ||
| Bisoprolol fumarate | Beta blocking agents | July 2017 | ||
| Cemiplimab | Antineoplastic agents | August 2018 | ||
| Darvadstrocel | Unassigned | August 2018 | ||
| Decitabine | Antineoplastic agents | September 2018 | ||
| Dermatophagoides farinae, dermatophagoides pteronyssinus | Allergens | September 2017 | ||
| Dexamethasone sodium phosphate, netilmicin sulfate | Ophthalmologicals | February 2018 | ||
| Dolutegravir, lamivudine |
Antivirals for systemic use | October 2018 | ViiV Healthcare ULC |
Part of ‘aligned review’ with a health technology assessment organization |
| Dotatate | Diagnostic radiopharmaceuticals | September 2018 | ||
| Esketamine hydrochloride | Anesthetics | January 2019 | Janssen Inc | Being reviewed under the Priority Review Policy |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | February 2018 | ||
| Filgrastim (r-metHuG-CSF) | Immunostimulants | April 2018 | ||
| Fosfomycin sodium | Antibacterials for systemic use | November 2018 | Verity Pharmaceuticals Inc | Being reviewed under the Priority Review Policy |
| Galcanezumab | Analgesics | October 2018 | Eli Lilly Canada Inc | New active substance |
| Ganciclovir | Ophthalmologicals | February 2019 | Laboratoires Thea | |
| Gemtuzumab ozogamicin | Antineoplastic agents | February 2019 | Pfizer Canada ULC | New active substance |
| Glucagon | Pancreatic hormones | November 2018 | Eli Lilly Canada Inc | |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | May 2017 | ||
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | January 2019 | Seqirus UK Limited | |
| Halobetasol propionate, tazarotene | Corticosteroids, dermatological preparations | May 2018 | ||
| Hydrochlorothiazide, zofenopril calcium | Agents acting on the renin-angiotensin system | June 2018 | ||
| Hydrogen peroxide | Other dermatological preparations | December 2018 | Cipher Pharmaceuticals Inc | |
| Larotrectinib | Antineoplastic agents | November 2018 | Bayer Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment (HTA) organization |
| Levetiracetam | Antiepileptics | September 2018 | ||
| Magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, sodium citrate dihydrate, sodium phosphate dibasic, sodium phosphate monobasic, water | All other non-therapeutic products | November 2018 | Maco Pharma | |
| Mannitol | Diagnostic agents | August 2018 | ||
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | September 2016 | ||
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | February 2017 | ||
| Methylene blue | Diagnostic agents | October 2018 | Pendopharm Division of Pharmascience Inc | |
| Mometasone furoate | Corticosteroids, dermatological preparations | September 2017 | ||
| Naloxone hydrochloride dihydrate | All other therapeutic products | January 2018 | ||
| Neratinib maleate | Antineoplastic agents | September 2018 | ||
| Nicardipine hydrochloride | Calcium channel blockers | July 2018 | ||
| Niraparib | Antineoplastic agents | September 2018 | ||
| Patisiran | Other nervous system drugs | December 2018 | Alnylam Netherlands B.V. | New active substance Being reviewed under the Priority Review Policy |
| Plecanatide | Drugs for constipation | December 2018 | Cipher Pharmaceuticals Inc | New active substance |
| Prasterone | Anabolic agents for systemic use | December 2016 | ||
| Ravulizumab | Immunosuppressants | November 2018 | Alexion Pharma GmbH | New active substance |
| Risankizumab | Immunosuppressants | June 2018 | ||
| Rituximab | Antineoplastic agents | September 2017 | ||
| Rituximab | Antineoplastic agents | September 2017 | ||
| Rituximab | Antineoplastic agents | September 2017 | ||
| Rituximab | Antineoplastic agents | April 2018 | ||
| Romosozumab | Drugs for treatment of bone diseases | October 2016 | ||
| Siponimod fumarate | Immunosuppressants | February 2019 | Novartis Pharmaceuticals Canada Inc | New active substance |
| Sodium zirconium cyclosilicate | All other therapeutic products | September 2018 | ||
| Sotagliflozin | Drugs used in diabetes | August 2018 | ||
| Talazoparib | Antineoplastic agents | November 2018 | Pfizer Canada Inc | New active substance |
| Teriparatide | Calcium homeostasis | June 2018 | ||
| Tibolone | Sex hormones and modulators of the genital system | October 2017 | ||
| Tildrakizumab | Immunosuppressants | February 2019 | Sun Pharma Global FZE | New active substance |
| Trastuzumab | Antineoplastic agents | June 2017 | ||
| Trastuzumab | Antineoplastic agents | October 2017 | ||
| Trastuzumab | Antineoplastic agents | November 2017 | ||
| Trastuzumab | Antineoplastic agents | November 2017 | ||
| Trastuzumab | Antineoplastic agents | November 2017 | ||
| Trastuzumab | Antineoplastic agents | February 2018 | ||
| Trastuzumab | Antineoplastic agents | February 2018 | ||
| Trifarotene | Anti-acne preparations | January 2019 | Galderma Canada Inc | New active substance |
| Turoctocog alfa pegol | Antihemorrhagics | September 2018 | ||
| Vitamin D3 | Vitamins | January 2019 | Galephar Pharmaceutical Research Inc | |
| Zofenopril calcium | Agents acting on the renin-angiotensin system | June 2018 |
*For submissions accepted into review on or after October 1, 2018 only.
| Medicinal Ingredient(s) | Therapeutic Area | Month, Year Submission was Accepted into Review | Company Name* | |
|---|---|---|---|---|
| Adalimumab | Immunosuppressants | October 2018 | Amgen Canada Inc | Biosimilar |
| Alirocumab | Lipid modifying agents | October 2018 | Sanofi-Aventis Canada Inc | |
| Atezolizumab | Antineoplastic agents | July 2018 | ||
| Atezolizumab | Antineoplastic agents | February 2019 | Hoffmann La Roche Limited | Being reviewed under the Priority Review Policy |
| Atezolizumab | Antineoplastic agents | February 2019 | Hoffmann La Roche Limited | Being reviewed under the Priority Review Policy |
| Azelastine hydrochloride, fluticasone propionate | Nasal preparations | December 2018 | BGP Pharma ULC | |
| Bevacizumab | Antineoplastic agents | September 2018 | ||
| Blinatumomab | Antineoplastic agents | December 2017 | ||
| Brentuximab vedotin | Antineoplastic agents | July 2018 | ||
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | September 2018 | ||
| Budesonide, formoterol fumarate dihydrate | Drugs for obstructive airway diseases | November 2018 | AstraZeneca Canada Inc | |
| Cabozantinib | Antineoplastic agents | December 2018 | Ipsen Biopharmaceuticals Canada Inc | |
| Cabozantinib | Antineoplastic agents | January 2019 | Ipsen Biopharmaceuticals Canada Inc | |
| Certolizumab pegol | Immunosuppressants | January 2019 | UCB Canada Inc | |
| Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use | October 2018 | Gilead Sciences Canada Inc | |
| Corynebacterium diphtheriae crm-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F | Vaccines | June 2018 | ||
| Dapagliflozin | Drugs used in diabetes | June 2018 | ||
| Dexlansoprazole | Drugs for acid related disorders | June 2018 | ||
| Dupilumab | Other dermatological preparations | November 2018 | Sanofi-Aventis Canada Inc | |
| Eltrombopag olamine | Antihemorrhagics | June 2018 | ||
| Eltrombopag olamine | Antihemorrhagics | July 2018 | ||
| Emicizumab | Antihemorrhagics | December 2018 | Hoffmann La Roche Limited | Being reviewed under the Priority Review Policy |
| Empagliflozin | Drugs used in diabetes | January 2019 | Boehringer Ingelheim (Canada) Ltd Ltee | |
| Glecaprevir, pibrentasvir | Antivirals for systemic use | December 2018 | Abbvie Corporation | Being reviewed under the Priority Review Policy |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) | Vaccines | August 2018 | ||
| Hydromorphone hydrochloride | Analgesics | January 2019 | Sandoz Canada Incorporated | Being reviewed under the Priority Review Policy Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Ibrutinib | Antineoplastic agents | January 2019 | Janssen Inc | |
| Icatibant acetate | Other hematological agents | September 2018 | ||
| Immunoglobulin (human) | Immune sera and immunoglobulins | February 2019 | Octapharma Pharmazeutika Produktionsges M B H | |
| IncobotulinumtoxinA | Muscle relaxants | October 2017 | ||
| Infliximab | Immunosuppressants | November 2018 | Celltrion Healthcare Co Ltd | Biosimilar |
| Levomilnacipran | Psychoanaleptics | January 2019 | Allergan Inc | |
| Linagliptin | Drugs used in diabetes | January 2019 | Boehringer Ingelheim (Canada) Ltd Ltee | |
| Macitentan | Antihypertensives | November 2018 | Janssen Inc | |
| Macitentan | Antihypertensives | January 2019 | Janssen Inc | |
| Methylphenidate hydrochloride | Psychoanaleptics | May 2018 | ||
| Naloxegol oxalate | Drugs for constipation | November 2018 | Knight Therapeutics Inc | |
| Nivolumab | Antineoplastic agents | June 2018 | ||
| Olaparib | Antineoplastic agents | November 2018 | AstraZeneca Canada Inc | Reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment (HTA) organization |
| Palbociclib | Antineoplastic agents | October 2018 | Pfizer Canada Inc | |
| Palonosetron hydrochloride | Antiemetics and antinauseants | June 2018 | ||
| Pembrolizumab | Antineoplastic agents | September 2017 | ||
| Pembrolizumab | Antineoplastic agents | May 2018 | ||
| Pembrolizumab | Antineoplastic agents | June 2018 | ||
| Pembrolizumab | Antineoplastic agents | August 2018 | ||
| Pembrolizumab | Antineoplastic agents | September 2018 | ||
| Pembrolizumab | Antineoplastic agents | October 2018 | Merck Canada Inc | Part of an 'aligned review' with a health technology assessment (HTA) organization |
| Pembrolizumab | Antineoplastic agents | February 2019 | Merck Canada Inc | |
| Pimecrolimus | Other dermatological preparations | November 2018 | Valeant Canada LP Valeant Canada S.E.C. | |
| Pomalidomide | Immunosuppressants | September 2018 | ||
| Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | February 2019 | Merck Canada Inc | |
| Sarilumab | Immunosuppressants | January 2018 | ||
| Secukinumab | Immunostimulants | September 2018 | ||
| Sunitinib malate | Antineoplastic agents | October 2017 | ||
| Teduglutide | Other alimentary tract and metabolism products | February 2019 | Shire Pharmaceuticals Ireland Limited | Reviewed under the Priority Review Policy |
| Teriflunomide | Immunosuppressants | December 2018 | Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc | |
| Tocilizumab | Immunosuppressants | October 2018 | Hoffmann La Roche Limited | |
| Umeclidinium bromide | Drugs for obstructive airway diseases | Janvier 2019 | GlaxoSmithKline Inc |
*For submissions accepted into review on or after October 1, 2018 only.
| Medicinal Ingredient(s) | Therapeutic Area | Month, Year Submission was Accepted into Review | Month, Year Submission Concluded | Outcome of Submission |
|---|---|---|---|---|
| Acetaminophen | Analgesics | February 2018 | November 2018 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | April 2017 | May 2018 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | April 2017 | May 2018 | Issued Notice of Compliance |
| Alectinib | Antineoplastic agents | February 2016 | September 2016 | Issued Notice of Compliance under the NOC/c Guidance |
| Alirocumab | Lipid modifying agents | June 2015 | April 2016 | Issued Notice of Compliance |
| Alvimopan | Drugs for constipation | March 2016 | March 2017 | Cancelled by sponsor |
| Amlodipine besylate | Calcium channel blockers | July 2018 | January 2019 | Issued Notice of Compliance |
| Anthrax antigen filtrate | Vaccines | February 2018 | December 2018 | Issued Notice of Compliance |
| Anthrax immunoglobulin (human) | Immune sera and immunoglobulins | January 2017 | November 2017 | Issued Notice of Compliance |
| Antihemophilic factor (human), Von Willebrand factor (human) | Antihemorrhagics | June 2017 | May 2018 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | January 2016 | November 2016 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant, B-domain deleted, pegylated) | Antihemorrhagics | December 2017 | October 2018 | Issued Notice of Compliance |
| Apalutamide | Endocrine therapy | January 2018 | July 2018 | Issued Notice of Compliance |
| Ataluren | Other drugs for disorders of the musculo-skeletal system | September 2015 | March 2016 | Cancelled by sponsor |
| Atezolizumab | Antineoplastic agents | August 2016 | April 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Avelumab | Antineoplastic agents | April 2017 | December 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Avelumab | Antineoplastic agents | September 2017 | May 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Axicabtagene ciloleucel | Antineoplastic agents | August 2018 | February 2019 | Issued Notice of Compliance |
| Baricitinib | Antiinflammatory and antirheumatic products | May 2016 | August 2018 | Issued Notice of Compliance |
| Benralizumab | Immunosuppressants | April 2017 | February 2018 | Issued Notice of Compliance |
| Bepotastine besilate | Ophthalmologicals | October 2015 | July 2016 | Issued Notice of Compliance |
| Betamethasone valerate, fusidic acid | Corticosteroids, dermatological preparations | June 2017 | April 2018 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | February 2017 | April 2018 | Issued Notice of Compliance |
| Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | September 2017 | July 2018 | Issued Notice of Compliance |
| Bilastine | Antihistamines for systemic use | June 2015 | April 2016 | Issued Notice of Compliance |
| Blinatumomab | Antineoplastic agents | April 2015 | December 2015 | Issued Notice of Compliance under the NOC/c Guidance |
| Botulinum antitoxin, serotypes A, B, C, D, E, F, G | Immune sera and immunoglobulins | February 2016 | December 2016 | Issued Notice of Compliance |
| Brexpiprazole | Psycholeptics | April 2016 | February 2017 | Issued Notice of Compliance |
| Brigatinib | Antineoplastic agents | November 2017 | July 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Brivaracetam | Antiepileptics | May 2015 | March 2016 | Issued Notice of Compliance |
| Brodalumab | Immunosuppressants | July 2016 | March 2018 | Issued Notice of Compliance |
| Buprenorphine | Other nervous system drugs | May 2018 | November 2018 | |
| Buprenorphine hydrochloride | Other nervous system drugs | August 2016 | June 2017 | Issued Notice of Compliance |
| Buprenorphine hydrochloride | Other nervous system drugs | June 2017 | April 2018 | Issued Notice of Compliance |
| Bupropion hydrochloride, naltrexone hydrochloride | Antiobesity preparations, excluding diet products | April 2017 | February 2018 | Issued Notice of Compliance |
Burosumab |
Drugs for treatment of bone diseases |
June 2018 |
December 2018 |
|
| C1 esterase inhibitor (human) | Other hematological agents | November 2016 | September 2017 | Issued Notice of Compliance |
| Cabozantinib | Antineoplastic agents | July 2017 | September 2018 | Issued Notice of Compliance |
| Calcifediol | Vitamins | September 2017 | July 2018 | Issued Notice of Compliance |
Canakinumab |
Immunosuppressants |
June 2018 |
December 2018 |
Cancelled by sponsor |
| Carfilzomib | Antineoplastic agents | July 2015 | January 2016 | Issued Notice of Compliance |
| Cefixime | Antibacterials for systemic use | May 2016 | October 2017 | Issued Notice of Compliance |
Cenegermin |
Ophthalmologicals |
August 2018 |
February 2019 |
|
| Cerliponase alfa | Other alimentary tract and metabolism products |
June 2018 |
December 2018 |
|
| Cidofovir | Antivirals for systemic use | April 2017 | March 2018 | Issued Notice of Compliance |
| Cinnarizine, dimenhydrinate | Other nervous system drugs | September 2016 | February 2019 | Issued Notice of Non-compliance- Withdrawal |
| Cladribine | Immunosuppressants | February 2017 | November 2017 | Issued Notice of Compliance |
| Clozapine | Psycholeptics | May 2016 | November 2016 | Issued Notice of Compliance |
| Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | February 2017 | November 2017 | Issued Notice of Compliance |
| Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | May 2017 | March 2018 | Issued Notice of Compliance |
| Cobimetinib fumarate | Antineoplastic agents | April 2015 | February 2016 | Issued Notice of Compliance |
| Crisaborole | Other dermatological preparations | August 2017 | June 2018 | Issued Notice of Compliance |
| Cyclosporin | Ophthalmologicals | August 2016 | April 2018 | Issued Notice of Non-compliance-Withdrawal |
| Cyclosporin | Ophthalmologicals | July 2018 | December 2018 | Issued Notice of Compliance |
| Cysteamine hydrochloride | Ophthalmologicals | February 2018 | February 2019 | Issued Notice of Compliance |
| Daclizumab | Immunosuppressants | February 2016 | December 2016 | Issued Notice of Compliance |
| Dacomitinib | Antineoplastic agents | May 2018 | February 2019 | Issued Notice of Compliance |
| Dalbavancin | Antibacterials for systemic use | March 2018 | September 2018 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | November 2015 | June 2016 | Issued Notice of Compliance under the NOC/c Guidance |
| Decitabine | Antineoplastic agents | March 2018 | January 2019 | Issued Notice of Compliance |
| Defibrotide | Antithrombotic agents | January 2017 | July 2017 | Issued Notice of Compliance |
| Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | July 2016 | May 2017 | Issued Notice of Compliance |
| Desvenlafaxine | Psychoanaleptics | February 2017 | August 2017 | Issued Notice of Compliance |
| Dinutuximab | Antineoplastic agents | February 2018 | November 2018 | Issued Notice of Compliance |
| Dolutegravir sodium, rilpivirine hydrochloride | Antivirals for systemic use | July 2017 | May 2018 | Issued Notice of Compliance |
| Doravirine | Antivirals for systemic use | December 2017 | December 2017 | Issued Notice of Compliance |
| Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | January 2018 | November 2018 | Issued Notice of Compliance |
| Dupilumab | Immunosuppressants | February 2017 | November 2017 | Issued Notice of Compliance |
| Durvalumab | Antineoplastic agents | March 2017 | November 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Durvalumab | Antineoplastic agents | September 2017 | May 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Edaravone | Other nervous system drugs | April 2018 | October 2018 | Issued Notice of Compliance |
| Edoxaban | Antithrombotic agents | December 2015 | November 2016 | Issued Notice of Compliance |
| Elagolix | Sex hormones and modulators of the genital system | December 2017 | October 2018 | Issued Notice of Compliance |
| Elbasvir, grazoprevir | Antivirals for systemic use | July 2015 | January 2016 | Issued Notice of Compliance |
| Eliglustat tartrate | Other alimentary tract and metabolism products | May 2015 | April 2017 | Issued Notice of Compliance |
| Elotuzumab | Antineoplastic agents | December 2015 | June 2016 | Issued Notice of Compliance |
| Eluxadoline | Drugs for functional gastrointestinal disorders | April 2016 | January 2017 | Issued Notice of Compliance |
| Emicizumab | Antihemorrhagics | February 2018 | August 2018 | Issued Notice of Compliance |
| Enasidenib mesylate | Antineoplastic agents | July 2018 | February 2019 | Issued Notice of Compliance under the NOC/c Guidance |
| Erenumab | Analgesics | October 2017 | August 2018 | Issued Notice of Compliance |
| Ertugliflozin pidolate | Drugs used in diabetes | July 2017 | May 2018 | Issued Notice of Compliance |
| Ertugliflozin pidolate, metformin hydrochloride | Drugs used in diabetes | August 2017 | May 2018 | Issued Notice of Compliance |
| Ertugliflozin pidolate, sitagliptin phosphate monohydrate | Drugs used in diabetes | July 2017 | May 2018 | Issued Notice of Compliance |
| Estriol, lactobacillus acidophilus | Sex hormones and modulators of the genital system | June 2017 | January 2019 | Issued a Notice of Deficiency-Withdrawal |
| Etanercept | Immunosuppressants | June 2016 | April 2017 | Issued Notice of Compliance |
| Fibrinogen (human) | Antihemorrhagics | August 2016 | June 2017 | Issued Notice of Compliance |
| Flibanserin | Other gynecologicals | April 2016 | February 2018 | Issued Notice of Compliance |
| Florbetaben (18F) | Diagnostic radiopharmaceuticals | April 2016 | February 2017 | Issued Notice of Compliance |
| Fluocinolone acetonide | Ophthalmologicals | February 2017 | November 2018 | Issued Notice of Compliance |
| Fluorouracil | Antineoplastic agents | April 2018 | February 2019 | Issued Notice of Compliance |
| Fluoxetine hydrochloride | Psychoanaleptics | December 2016 | June 2017 | Issued Notice of Compliance |
| Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | June 2017 | April 2018 | Issued Notice of Compliance |
| Fluticasone propionate | Drugs for obstructive airway diseases | October 2016 | August 2017 | Issued Notice of Compliance |
| Fluticasone proprionate, salmeterol xinafoate | Drugs for obstructive airway diseases | November 2016 | April 2018 | Issued Notice of Compliance |
| Follitropin delta | Sex hormones and modulators of the genital system | January 2016 | March 2018 | Issued Notice of Compliance |
| Formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | February 2017 | March 2018 | Issued Notice of Compliance |
| Gadoteric acid | Contrast media | December 2015 | November 2016 | Issued Notice of Compliance |
| Glecaprevir, pibrentasvir | Antivirals for systemic use | February 2017 | August 2017 | Issued Notice of Compliance |
| Glycopyrrolate | Drugs for functional gastrointestinal disorders | January 2017 | October 2017 | Issued Notice of Compliance |
| Guselkumab | Immunosuppressants | January 2017 | November 2017 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | April 2017 | February 2018 | Issued Notice of Compliance |
| Hemin | Other alimentary tract and metabolism | January 2018 | July 2018 | Issued Notice of Compliance |
| Human heterologous liver cells | Other alimentary tract and metabolism products | June 2017 | July 2018 | Cancelled by sponsor |
| Idarucizumab | All other therapeutic products | May 2015 | April 2016 | Issued Notice of Compliance under the NOC/c Guidance |
| Immunoglobulin (human) | Immune sera and immunoglobulins | October 2016 | August 2017 | Issued Notice of Compliance |
| Immunoglobulin G (human) | Immune sera and immunoglobulins | April 2017 | February 2018 | Issued Notice of Compliance |
| Inotersen sodium | Other nervous system drugs | April 2018 | October 2018 | Issued Notice of Compliance |
| Inotuzumab ozogamicin | Antineoplastic agents | May 2017 | March 2018 | Issued Notice of Compliance |
| Insulin degludec | Drugs used in diabetes | October 2016 | August 2017 | Issued Notice of Compliance |
| Insulin degludec, liraglutide | Drugs used in diabetes | June 2017 | April 2018 | Issued Notice of Compliance |
| Insulin glargine | Drugs used in diabetes | April 2017 | February 2019 | Cancelled by sponsor |
| Insulin glargine, lixisenatide | Drugs used in diabetes | September 2017 | July 2018 | Issued Notice of Compliance |
| Insulin injection human biosynthetic | Drugs used in diabetes | September 2016 | July 2017 | Issued Notice of Compliance |
| Insulin lispro | Drugs used in diabetes | January 2017 | November 2017 | Issued Notice of Compliance |
| Iodine | Contrast media | September 2016 | July 2017 | Issued Notice of Compliance |
| Ioflupane (123I) | Diagnostic radiopharmaceuticals | February 2017 | December 2017 | Issued Notice of Compliance |
| Iron dextran | Antianemic preparations | May 2016 | June 2017 | Cancelled by sponsor |
| Iron isomaltoside 1000 | Antianemic preparations | July 2016 | June 2018 | Issued Notice of Compliance |
Isavuconazonium sulfate |
Antimycotics for systemic use |
February 2018 |
December 2018 |
Issued Notice of Compliance |
| Ivacaftor, tezacaftor | Other respiratory system products | December 2017 | June 2018 | Issued Notice of Compliance |
| Ivermectin | Anthelmintics | December 2017 | September 2018 | Issued Notice of Compliance |
| Ixazomib citrate | Antineoplastic agents | February 2016 | August 2016 | Issued Notice of Compliance |
| Ixekizumab | Immunosuppressants | July 2015 | May 2016 | Issued Notice of Compliance |
| Lanadelumab | Other hematological agents | March 2018 | September 2018 | Issued Notice of Compliance |
Latanoprostene bunod |
Ophthalmologicals |
March 2018 |
December 2018 |
Issued Notice of Compliance |
| Letermovir | Antivirals for systemic use | May 2017 | November 2017 | Issued Notice of Compliance |
| Lifitegrast | Ophthalmologicals | December 2016 | December 2017 | Issued Notice of Compliance |
| Lixisenatide | Drugs used in diabetes | June 2016 | May 2017 | Issued Notice of Compliance |
| Lonoctocog alfa | Antihemorrhagics | February 2016 | December 2016 | Issued Notice of Compliance |
| Lorcaserin hydrochloride | Antiobesity preparations, excluding diet products | November 2016 | February 2018 | Cancelled by sponsor |
| Lorlatinib | Antineoplastic agents | June 2018 | February 2019 | Issued Notice of Compliance under the NOC/c Guidance |
| Lutetium (177Lu) oxodotretotide | Therapeutic radiopharmaceuticals | July 2018 | January 2019 | Issued Notice of Compliance |
| Mercaptamine bitartrate | Other alimentary tract and metabolism products | March 2016 | June 2017 | Issued Notice of Compliance |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | May 2017 | March 2018 | Issued Notice of Compliance |
| Methoxyflurane | Analgesics | June 2017 | April 2018 | Issued Notice of Compliance |
| Midostaurin | Antineoplastic agents | January 2017 | July 2017 | Issued Notice of Compliance |
| Migalastat hydrochloride | Other alimentary tract and metabolism products | November 2016 | September 2017 | Issued Notice of Compliance |
| Naloxone hydrochloride | All other therapeutic products | April 2016 | October 2016 | Issued Notice of Compliance |
| Necitumumab | Antineoplastic agents | May 2016 | March 2017 | Issued Notice of Compliance |
| Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B | Vaccines | July 2016 | October 2017 | Issued Notice of Compliance |
| Netupitant, palonosetron hydrochloride | Antiemetics and antinauseants | December 2016 | September 2017 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | March 2016 | September 2016 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | May 2016 | November 2016 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | July 2016 | December 2016 | Issued Notice of Compliance |
| Nusinersen | Other drugs for disorders of the musculo-skeletal systemOther | December 2016 | June 2017 | Issued Notice of Compliance |
| Obeticholic acid | Bile and liver therapy | October 2016 | May 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Ocrelizumab | Immunosuppressants | October 2016 | August 2017 | Issued Notice of Compliance |
| Ocrelizumab | Immunosuppressants | October 2016 | February 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Olaparib | Antineoplastic agents | June 2015 | April 2016 | Issued Notice of Compliance under the NOC/c Guidance |
| Olaratumab | Antineoplastic agents | April 2017 | November 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Osimertinib | Antineoplastic agents | November 2015 | July 2016 | Issued Notice of Compliance under the NOC/c Guidance |
Oxycodone |
Analgesics |
November 2015 |
July 2018 |
|
| Ozenoxacin | Antibiotics and chemotherapy for dermatological use | July 2016 | May 2017 | Issued Notice of Compliance |
| Panobinostat | Antineoplastic agents | November 2015 | June 2016 | Cancelled by sponsor |
| Patiromer sorbitex calcium | All other therapeutic products | December 2017 | October 2018 | Issued Notice of Compliance |
| Pegaspargase | Antineoplastic agents | May 2016 | February 2017 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | June 2017 | April 2018 | Issued Notice of Compliance |
Pegfilgrastim |
Immunostimulants |
January 2017 |
December 2018 |
Issued Notice of Compliance |
| Peramivir | Antivirals for systemic use | March 2016 | January 2017 | Issued Notice of Compliance |
| Perindopril arginine | Agents acting on the renin-angiotensin system | August 2017 | March 2018 | Issued Notice of Compliance |
| PrabotulinumtoxinA | Muscle relaxants | October 2017 | August 2018 | Issued Notice of Compliance |
| Pralatrexate | Antineoplastic agents | November 2017 | October 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Progesterone | Sex hormones and modulators of the genital system | February 2018 | August 2018 | Issued Notice of Compliance |
| Propiverine hydrochloride | Urologicals | March 2016 | January 2017 | Issued Notice of Compliance |
| Rabies immune globulin human | Immune sera and immunoglobulins | January 2018 | November 2018 | Issued Notice of Compliance |
| Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) | Antihemorrhagics | April 2015 | January 2016 | Issued Notice of Compliance |
| Reslizumab | Immunosuppressants | September 2015 | July 2016 | Issued Notice of Compliance |
| Ribociclib | Antineoplastic agents | May 2017 | March 2018 | Issued Notice of Compliance |
| Rupatadine fumarate | Antihistamines for systemic use | September 2015 | July 2016 | Issued Notice of Compliance |
| Safinamide | Anti-parkinson drugs | March 2018 | January 2019 | Issued Notice of Compliance |
| Salbutamol sulfate | Drugs for obstructive airway diseases | November 2016 | November 2017 | Issued Notice of Compliance |
| Sarilumab | Immunosuppressants | March 2016 | January 2017 | Issued Notice of Compliance |
| Sebelipase alfa | Other alimentary tract and metabolism products | April 2017 | December 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Semaglutide | Drugs used in diabetes | March 2017 | January 2018 | Issued Notice of Compliance |
| Sirukumab | Immunosuppressants | June 2017 | October 2017 | Cancelled by sponsor |
| Sofosbuvir, velpatasvir | Antivirals for systemic use | January 2016 | July 2016 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir, voxilaprevir | Antivirals for systemic use | February 2017 | August 2017 | Issued Notice of Compliance |
| Sucroferric oxyhydroxide | All other therapeutic products | February 2017 | January 2018 | Issued Notice of Compliance |
| Sugammadex | All other therapeutic products | April 2015 | February 2016 | Issued Notice of Compliance |
| Suvorexant | Psycholeptics | August 2016 | November 2018 | Issued Notice of Compliance |
| Tacrolimus | Immunosuppressants | April 2018 | February 2019 | Issued Notice of Compliance |
| Telotristat etiprate | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | December 2017 | October 2018 | Issued Notice of Compliance |
| Tenofovir alafenamide hemifumarate | Antivirals for systemic use | July 2016 | May 2017 | Issued Notice of Compliance |
| Tipiracil hydrochloride, trifluridine | Antineoplastic agents | July 2017 | January 2018 | Issued Notice of Compliance |
| Tisagenlecleucel-T | Antineoplastic agents | March 2018 | September 2018 | Issued Notice of Compliance |
| Tisagenlecleucel-T | Antineoplastic agents | March 2018 | September 2018 | Issued Notice of Compliance |
| Triamcinolone hexacetonide | Corticosteroids for systemic use | February 2017 | December 2017 | Issued Notice of Compliance |
| Varicella-zoster virus glycoprotein E (GE) | Vaccines | December 2016 | October 2017 | Issued Notice of Compliance |
| Venetoclax | Antineoplastic agents | February 2016 | September 2016 | Issued Notice of Compliance under the NOC/c Guidance |
| Vernakalant hydrochloride | Cardiac therapy | May 2016 | March 2017 | Issued Notice of Compliance |
| Volanesorsen | Lipid modifying agents | November 2017 | November 2018 | Issued Notice of Non-compliance – Withdrawal |
| Vonicog alfa | Antihemorrhagics | March 2018 | January 2019 | Issued Notice of Compliance |
| Medicinal Ingredient(s) | Therapeutic Area | Month, Year Submission was Accepted into Review | Month, Year Submission Concluded | Outcome of Submission |
|---|---|---|---|---|
| Abacavir sulfate, dolutegravir sodium, lamivudine | Antivirals for systemic use | August 2017 | October 2017 | Issued Notice of Compliance |
| Abatacept | Immunosuppressants | May 2017 | March 2018 | Issued Notice of Compliance |
| Abiraterone acetate | Endocrine therapy | August 2017 | February 2018 | Issued Notice of Compliance |
| AbobotulinumtoxinA | Muscle relaxants | March 2017 | December 2017 | Issued Notice of Compliance |
| AbobotulinumtoxinA | Muscle relaxants | May 2017 | March 2018 | Issued Notice of Compliance |
| AbobotulinumtoxinA | Muscle relaxants | August 2017 | April 2018 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | September 2016 | July 2017 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | February 2017 | December 2017 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | February 2018 | November 2018 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | March 2018 | January 2019 | Issued Notice of Compliance |
| Afatinib dimaleate | Antineoplastic agents | December 2017 | September 2018 | Issued Notice of Compliance |
| Alectinib | Antineoplastic agents | December 2017 | June 2018 | Issued Notice of Compliance |
| Anakinra | Immunosuppressants | July 2016 | May 2017 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | January 2018 | November 2018 | Issued Notice of Compliance |
| Apixaban | Antithrombotic agents | November 2016 | October 2018 | Issued Notice of Compliance |
| Aripiprazole | Psycholeptics | January 2017 | November 2017 | Issued Notice of Compliance |
| Atezolizumab | Antineoplastic agents | June 2017 | April 2018 | Issued Notice of Compliance |
| Bazedoxifene acetate, conjugated estrogens | Sex hormones and modulators of the genital system | November 2017 | September 2018 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | August 2017 | June 2018 | Issued Notice of Compliance |
| Blinatumomab | Antineoplastic agents | September 2016 | April 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Blinatumomab | Antineoplastic agents | May 2017 | March 2018 | Issued Notice of Compliance |
Bosutinib |
Antineoplastic agents |
February 2018 |
December 2018 |
Issued Notice of Compliance |
| Brentuximab vedotin | Antineoplastic agents | April 2018 | December 2018 | Issued Notice of Compliance |
| Brexpiprazole | Psycholeptics | July 2017 | February 2019 | Issued Notice of Compliance |
| C1 esterase inhibitor (human) | Other hematological agents | September 2016 | March 2017 | Issued Notice of Compliance |
| Canagliflozin | Drugs used in diabetes | June 2016 | April 2017 | Issued Notice of Compliance |
| Canagliflozin | Drugs used in diabetes | December 2017 | October 2018 | Issued Notice of Compliance |
| Canagliflozin, metformin hydrochloride | Drugs used in diabetes | December 2017 | October 2018 | Issued Notice of Compliance |
| Canakinumab | Immunosuppressants | July 2016 | January 2017 | Issued Notice of Compliance |
| Certolizumab pegol | Immunosuppressants | October 2017 | August 2018 | Issued Notice of Compliance |
| Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | August 2016 | May 2017 | Issued Notice of Compliance |
| Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | August 2017 | June 2018 | Issued Notice of Compliance |
| Collagenase clostridium histolyticum | Other drugs for disorders of the musculo-skeletal system | March 2017 | January 2018 | Issued Notice of Compliance |
| Crizotinib | Antineoplastic agents | November 2016 | August 2017 | Issued Notice of Compliance |
| Dabrafenib | Antineoplastic agents | November 2016 | May 2017 | Issued Notice of Compliance |
| Dabrafenib | Antineoplastic agents | November 2017 | May 2018 | Issued Notice of Compliance |
| Dabrafenib | Antineoplastic agents | March 2018 | September 2018 | Issued Notice of Compliance |
| Daptomycin | Antibacterials for systemic use | May 2018 | February 2019 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | October 2016 | April 2017 | Issued Notice of Compliance |
| Daratumumab | Antineoplastic agents | January 2018 | November 2018 | Issued Notice of Compliance |
| Denosumab | Drugs for treatment of bone diseases | April 2017 | February 2018 | Issued Notice of Compliance |
| Denosumab | Drugs for treatment of bone diseases | June 2017 | April 2018 | Issued Notice of Compliance |
| Dimethyl fumarate | Other nervous system drugs | April 2018 | February 2019 | Issued Notice of Compliance |
| Dolutegravir | Antivirals for systemic use | August 2017 | May 2018 | Issued Notice of Compliance |
| Dulaglutide | Drugs used in diabetes | March 2017 | December 2017 | Issued Notice of Compliance |
| Eculizumab | Immunosuppressants | February 2018 | August 2018 | Issued Notice of Compliance |
| Eltrombopag olamine | Antihemorrhagics | July 2016 | May 2017 | Issued Notice of Compliance |
| Empagliflozin | Drugs used in diabetes | May 2016 | April 2018 | Issued Notice of Compliance |
| Empagliflozin, linagliptin | Drugs used in diabetes | June 2017 | April 2018 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | November 2017 | September 2018 | Issued Notice of Compliance |
Enzalutamide |
Endocrine therapy |
June 2018 |
December 2018 |
Issued Notice of Compliance |
| Eptacog alfa | Antihemorrhagics | January 2017 | November 2017 | Issued Notice of Compliance |
| Eribulin mesylate | Antineoplastic agents | October 2016 | August 2017 | Issued Notice of Compliance |
| Erlotinib hydrochloride | Antineoplastic agents | June 2016 | March 2017 | Issued Notice of Compliance |
| Eslicarbazepine acetate | Antiepileptics | September 2017 | June 2018 | Issued Notice of Compliance |
| Eslicarbazepine acetate | Antiepileptics | November 2017 | September 2018 | Issued Notice of Compliance |
| Etanercept | Immunosuppressants | May 2016 | March 2017 | Issued Notice of Compliance |
| Etanercept | Immunosuppressants | March 2018 | January 2019 | Issued Notice of Compliance |
| Everolimus | Antineoplastic agents | January 2017 | November 2017 | Issued Notice of Compliance |
| Evolocumab | Lipid modifying agents | August 2017 | June 2018 | Issued Notice of Compliance |
| Evolocumab | Lipid modifying agents | October 2017 | August 2018 | Issued Notice of Compliance |
| Exenatide | Drugs used in diabetes | September 2017 | July 2018 | Issued Notice of Compliance |
| Fingolimod hydrochloride | Immunosuppressants | May 2018 | November 2018 | Issued Notice of Compliance |
| Fluticasone furoate | Drugs for obstructive airway diseases | October 2017 | October 2018 | Cancelled by sponsor |
| Fulvestrant | Endocrine therapy | January 2017 | November 2017 | Issued Notice of Compliance |
| Gadoterate meglumine | Contrast media | June 2017 | April 2018 | Issued Notice of Compliance |
| Glycopyrronium bromide, indacaterol maleate | Drugs for obstructive airway diseases | November 2016 | August 2017 | Issued Notice of Compliance |
| Golimumab | Immunosuppressants | September 2016 | June 2017 | Issued Notice of Compliance |
| Golimumab | Immunosuppressants | June 2017 | April 2018 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | November 2016 | May 2017 | Issued Notice of Compliance |
| Human immunoglobulin | Immune sera and immunoglobulins | September 2017 | July 2018 | Issued Notice of Compliance |
| Ibrutinib | Immunosuppressants | May 2017 | October 2017 | Issued Notice of Compliance |
| Ibrutinib | Antineoplastic agents | February 2018 | July 2018 | Issued Notice of Compliance |
| Ibrutinib | Antineoplastic agents | August 2018 | February 2019 | Issued Notice of Compliance |
| Idelalisib | Antineoplastic agents | April 2017 | December 2017 | Cancelled by sponsor |
| Immune globulin (human) | Immune sera and immunoglobulins | January 2017 | October 2017 | Issued Notice of Compliance |
| Insulin degludec | Drugs used in diabetes | October 2017 | July 2018 | Issued Notice of Compliance |
| Ipilimumab | Antineoplastic agents | February 2017 | April 2017 | Issued Notice of Compliance |
| Ivacaftor | Other respiratory system products | August 2018 | January 2019 | Issued Notice of Compliance |
| Ivacaftor, lumacaftor | Other respiratory system products | October 2016 | April 2017 | Issued Notice of Compliance |
Ivacaftor, lumacaftor |
Other respiratory system products |
June 2018 |
December 2018 |
Issued Notice of Compliance |
| Ixekizumab | Immunosuppressants | June 2017 | March 2018 | Issued Notice of Compliance |
| Japanese encephalitis virus vaccine inactivated | Vaccines | May 2017 | March 2018 | Issued Notice of Compliance |
| Lacosamide | Antiepileptics | May 2016 | February 2017 | Issued Notice of Compliance |
| Lanreotide acetate | Pituitary and hypothalamic hormones and analogues | April 2017 | February 2018 | Issued Notice of Compliance |
| Ledipasvir, sofosbuvir | Antivirals for systemic use | December 2016 | May 2017 | Issued Notice of Compliance |
| Lenvatinib mesylate | Antineoplastic agents | November 2016 | September 2017 | Issued Notice of Compliance |
Lenvatinib mesylate |
Antineoplastic agents |
February 2018 |
December 2018 |
Issued Notice of Compliance |
| Leuprolide acetate | Endocrine therapy | May 2016 | February 2017 | Issued Notice of Compliance |
| Levonorgestrel | Sex hormones and modulators of the genital system | May 2017 | March 2018 | Issued Notice of Compliance |
| Linagliptin | Drugs used in diabetes | June 2016 | October 2018 | Issued Notice of Compliance |
| Linagliptin, metformin hydrochloride | Drugs used in diabetes | June 2016 | May 2017 | Cancelled by sponsor |
| Liraglutide | Drugs used in diabetes | August 2016 | June 2017 | Issued Notice of Compliance |
| Liraglutide | Drugs used in diabetes | January 2017 | November 2017 | Issued Notice of Compliance |
| Lurasidone hydrochloride | Psycholeptics | September 2016 | July 2017 | Issued Notice of Compliance |
| Lurasidone hydrochloride | Psycholeptics | June 2017 | April 2018 | Issued Notice of Compliance |
| Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid | Vaccines | April 2017 | February 2018 | Issued Notice of Compliance |
| Mepolizumab | Drugs for obstructive airway diseases | September 2017 | July 2018 | Issued Notice of Compliance |
Mepolizumab |
Drugs for obstructive airway diseases |
February 2018 |
October 2018 |
|
| Midostaurin | Antineoplastic agents | December 2017 | October 2018 | Issued Notice of Compliance |
| Mifepristone, misoprostol | Sex hormones and modulators of the genital system | January 2017 | November 2017 | Issued Notice of Compliance |
| Nadroparin calcium | Antithrombotic agents | August 2016 | July 2017 | Issued Notice of Compliance |
| Nilotinib | Antineoplastic agents | December 2017 | October 2018 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | November 2016 | May 2017 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | March 2017 | November 2017 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | April 2017 | January 2018 | Cancelled by sponsor |
| Nivolumab | Antineoplastic agents | July 2017 | March 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Nivolumab | Antineoplastic agents | January 2018 | July 2018 | Issued Notice of Compliance |
| Nivolumab | Antineoplastic agents | January 2018 | November 2018 | Issued Notice of Compliance |
| Norfloxacin | Antibacterials for systemic use | October 2017 | December 2017 | Issued Notice of Compliance |
| Obinutuzumab | Antineoplastic agents | September 2017 | July 2018 | Issued Notice of Compliance |
| Olaparib | Antineoplastic agents | November 2017 | May 2018 | Issued Notice of Compliance |
| Omalizumab | Drugs for obstructive airway diseases | June 2016 | April 2017 | Issued Notice of Compliance |
| Ombitasvir, paritaprevir, ritonavir | Antivirals for systemic use | July 2016 | May 2017 | Issued Notice of Compliance |
| OnabotulinumtoxinA | Muscle relaxants | December 2017 | October 2018 | Issued Notice of Compliance |
| Osimertinib mesylate | Antineoplastic agents | January 2018 | July 2018 | Issued Notice of Compliance |
| Outer membrane vesicles (Neisseria meningitidis group B NZ98/254 strain), recombinant Neisseria meningitidis group B NHBA fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B fHBP fusion protein | Vaccines | November 2017 | August 2018 | Issued Notice of Compliance |
| Palbociclib | Antineoplastic agents | August 2016 | May 2017 | Issued Notice of Compliance |
| Panitumumab | Antineoplastic agents | June 2016 | April 2017 | Issued Notice of Compliance |
| Pasireotide | Pituitary and hypothalamic hormones and analogues | November 2017 | August 2018 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | January 2017 | September 2017 | Issued Notice of Compliance under the NOC/c Guidance |
| Pembrolizumab | Antineoplastic agents | March 2017 | September 2017 | Issued Notice of Compliance |
| Pembrolizumab | Antineoplastic agents | January 2018 | September 2018 | Issued Notice of Compliance under the NOC/c Guidance |
| Perampanel | Antiepileptics | May 2017 | March 2018 | Issued Notice of Compliance |
| Pertuzumab | Antineoplastic agents | November 2017 | August 2018 | Issued Notice of Compliance |
| Plerixafor | Immunostimulants | March 2018 | January 2019 | Issued Notice of Compliance |
| Ranibizumab | Ophthalmologicals | January 2017 | November 2017 | Issued Notice of Compliance |
| Regorafenib | Antineoplastic agents | April 2017 | September 2017 | Issued Notice of Compliance |
| Regorafenib | Antineoplastic agents | April 2018 | February 2019 | Issued Notice of Compliance |
Rifaximin |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
February 2018 |
December 2018 |
Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | May 2017 | March 2018 | Issued Notice of Compliance |
| Rivaroxaban | Antithrombotic agents | January 2018 | September 2018 | Issued Notice of Compliance |
| Rufinamide | Antiepileptics | June 2016 | April 2017 | Issued Notice of Compliance |
| Sevelamer carbonate | All other therapeutic products | April 2018 | February 2019 | Issued Notice of Compliance |
| Simeprevir | Antivirals for systemic use | September 2016 | July 2017 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir | Antivirals for systemic use | December 2016 | September 2017 | Issued Notice of Compliance |
| Somatropin | Pituitary and hypothalamic hormones and analogues | June 2017 | April 2018 | Issued Notice of Compliance |
| Thioguanine | Antineoplastic agents | November 2016 | September 2017 | Issued Notice of Compliance |
| Tinzaparin sodium | Antithrombotic agents | December 2016 | November 2018 | Cancelled by sponsor |
| Tocilizumab | Immunosuppressants | May 2017 | October 2017 | Issued Notice of Compliance |
| Tofacitinib | Immunosuppressants | November 2017 | September 2018 | Issued Notice of Compliance |
| Tofacitinib | Immunosuppressants | December 2017 | October 2018 | Issued Notice of Compliance |
| Tofacitinib | Immunosuppressants | April 2018 | January 2019 | Issued Notice of Compliance |
| Tolvaptan | Diuretics | March 2018 | January 2019 | Issued Notice of Compliance |
| Trametinib | Antineoplastic agents | November 2016 | May 2017 | Issued Notice of Compliance |
| Trametinib | Antineoplastic agents | November 2017 | May 2018 | Issued Notice of Compliance |
| Trametinib | Antineoplastic agents | March 2018 | September 2018 | Issued Notice of Compliance |
| Venetoclax | Antineoplastic agents | March 2018 | September 2018 | Issued Notice of Compliance |
Vilazodone hydrochloride |
Psychoanaleptics |
November 2017 |
October 2018 |
|
Vortioxetine hydrobromide |
Psychoanaleptics |
February 2018 |
December 2018 |
Issued Notice of Compliance |
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