Drug and health product submissions under review (SUR)

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

On this page

About the Submissions Under Review (SUR) Lists

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

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

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

The Submissions Under Review (SUR) Lists include new drug submissions containing new active substances (pharmaceuticals and biologics with an active ingredient not approved in Canada). This applies to submissions accepted for review on or after April 1, 2015.

The lists also include submissions accepted for review on or after May 1, 2016, specifically:

  • new drug submissions
  • supplemental new drug submissions for new uses

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

Finding information on the lists

There are four Submissions Under Review (SUR) Lists, which contain:

  • new drug submissions currently under review
  • supplemental new drug submissions currently under review
  • new drug submissions formerly under review
  • supplemental new drug submissions formerly under review

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

Lists of submissions currently under review

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

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

  • company name
  • ‘class’ of the submission

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

Lists of submissions formerly under review

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

Decisions

A substance is removed from the submissions currently under review list and added to the submissions formerly under review list when:

  • the submission is cancelled or
  • a final decision is made and the submission is no longer under review

You can see if a submission has been approved in the Notice of Compliance Database.

Information about decisions (positive or negative) and cancellations can be found in the Regulatory Decision Summary. If applicable, a more detailed explanation is available in a Summary Basis of Decision document.

External Consultations

Several external consultations have been held as the SUR List initiative has evolved. In 2017, an external consultation was held on five transparency proposals for prescription drugs. This report provides a summary of the consultation results.

The purpose of this report is to provide a summary of the results of the on-line questionnaire posted in 2016. The subject of the questionnaire was health product transparency initiatives.

View the lists

You can view the drug and health product submission lists any time. The four lists are:

Submissions currently under review: New drug submissions
Medicinal Ingredient(s) Therapeutic Area Month, Year Submission was Accepted into Review Company Name* Submission ‘Class’*
Acalabrutinib Antineoplastic agents April 2018    
Adalimumab Immunosuppressants November 2018 Sandoz Canada Incorporated Biosimilar
Amoxicillin sodium, clavulanic acid Antibacterials for systemic use April 2019 Sandoz Canada Incorporated
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    
Darolutamide Endocrine therapy April 2019 Bayer Inc New active substance
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    
Erdafitinib Antineoplastic agents March 2019 Janssen Inc New active substance

Being reviewed under the Notice of Compliance with Conditions Guidance

Part of an 'aligned review' with a health technology assessment (HTA) organization
Esketamine hydrochloride 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    
Filgrastim (r-metHuG-CSF) Immunostimulants March 2019 Tanvex Biopharm USA, Inc Biosimilar
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
Gallium (68Ga) chloride Diagnostic radiopharmaceuticals April 2019 Ire Elit S.A. New active substance
Ganciclovir Ophthalmologicals February 2019 Laboratoires Thea  
Gemtuzumab ozogamicin Antineoplastic agents February 2019 Pfizer Canada ULC New active substance

Part of an 'aligned review' with a health technology assessment (HTA) organization
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 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    
Ospemifene Sex hormones and modulators of the genital system March 2019 Duchesnay Inc New active substance
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
Rituximab Antineoplastic agents April 2018    
Rituximab Antineoplastic agents March 2019 Pfizer Canada ULC Biosimilar
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    
Upadacitinib Immunosuppressants March 2019 Abbvie Corporation New active substance
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.

Submissions currently under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Month, Year Submission was Accepted into Review Company Name*

Submission ‘Class’*

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
Avelumab Antineoplastic agents April 2019 EMD Serono a Division of EMD Inc Canada Being reviewed under the Notice of Compliance with Conditions Guidance
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  
Ceftolozane, tazobactam sodium Antibacterials for systemic use March 2019 Merck Canada Inc Being reviewed under the Priority Review Policy
Certolizumab pegol Immunosuppressants January 2019 UCB Canada Inc  
Cobicistat,
elvitegravir,
emtricitabine,
tenofovir alafenamide hemifumarate
Antivirals for systemic use October 2018 Gilead Sciences Canada Inc  
Dupilumab Other dermatological preparations November 2018 Sanofi-Aventis Canada Inc  
Eculizumab Immunosuppressants April 2019 Alexion Pharma GmbH Being reviewed under the Priority Review Policy
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
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    
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines April 2019 BGP Pharma ULC  
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
Hydroxyethyl starch Blood substitutes and perfusion solutions April 2019 Fresenius Kabi Canada Ltd  
Hydroxyethyl starch Blood substitutes and perfusion solutions April 2019 Fresenius Kabi Canada Ltd  
Hydroxyurea Antineoplastic agents April 2019 Bristol-Myers Squibb Canada  
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
Ixekizumab Immunosuppressants April 2019 Eli Lilly Canada Inc  
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 March 2019 Purdue Pharma  
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
Olodaterol hydrochloride, tiotropium bromide monohydrate Drugs for obstructive airway diseases March 2019 Boehringer Ingelheim (Canada) Ltd Ltee  
Palbociclib Antineoplastic agents October 2018 Pfizer Canada Inc  
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  
Ribociclib succinate Antineoplastic agents April 2019 Novartis Pharmaceuticals Canada Inc  
Sarilumab Immunosuppressants January 2018    
Secukinumab Immunostimulants September 2018    
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 January 2019 GlaxoSmithKline Inc  
Ustekinumab Immunosuppressants March 2019 Janssen Inc  

*For submissions accepted into review on or after October 1, 2018 only.

Submissions formerly under review: New drug submissions
Medicinal Ingredient(s) Therapeutic Area Month, Year Submission was Accepted into Review Month, Year Submission Concluded Outcome of Submission
Abemaciclib Antineoplastic agents June 2018 April 2019 Issued Notice of Compliance
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

Issued Notice of Compliance

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

Issued Notice of Compliance

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
Cemiplimab Antineoplastic agents August 2018 April 2019 Issued Notice of Compliance under the NOC/c
Guidance

Cenegermin

Ophthalmologicals

August 2018

February 2019

Issued Notice of Compliance

Cerliponase alfa

Other alimentary tract and metabolism products

June 2018

December 2018

Issued Notice of Compliance

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
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines May 2017 March 2019 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

Cancelled by sponsor

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
Risankizumab Immunosuppressants June 2018 April 2019 Issued Notice of Compliance
Rituximab Antineoplastic agents September 2017 March 2019 Cancelled by sponsor
Rituximab Antineoplastic agents September 2017 March 2019 Cancelled by sponsor
Rituximab Antineoplastic agents September 2017 April 2019 Issued Notice of Compliance
Rituximab Antineoplastic agents March 2019 April 2019 Cancelled by sponsor
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
Submissions formerly under review: Supplemental new drug submissions for new uses
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
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 April 2019 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
Dapagliflozin Drugs used in diabetes June 2018 April 2019 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
Dexlansoprazole Drugs for acid related disorders June 2018 April 2019 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 Drugs used in diabetes January 2019 April 2019 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
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases May 2018 March 2019 Issued Notice of Compliance
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

Cancelled by sponsor

Methylphenidate hydrochloride Psychoanaleptics May 2018 March 2019 Issued Notice of Compliance
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
Palonosetron hydrochloride Antiemetics and antinauseants June 2018 April 2019 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
Pembrolizumab Antineoplastic agents May 2018 March 2019 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents September 2017 April 2019 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents June 2018 April 2019 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents August 2018 April 2019 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
Sunitinib malate Antineoplastic agents October 2017 April 2019 Issued Notice of Non-compliance- Withdrawal
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

Cancelled by sponsor

Vortioxetine hydrobromide

Psychoanaleptics

February 2018

December 2018

Issued Notice of Compliance

Questions can be sent to us by email.

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

Thank you for your help!

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

Date modified: