Drug and Health Product Submissions Under Review (SUR): New drug submissions completed

Submissions formerly under review: New drug submissions
Medicinal Ingredient(s) Therapeutic Area Submission Control Number Year, Month Submission was Accepted into Review Year, Month Submission Concluded Outcome of SubmissionFootnote a
5‑Aminolevulinic acid Antineoplastic agents 234673 2020-03 2020-09 Issued Notice of Compliance
Abemaciclib Antineoplastic agents 215268 2018-06 2019-04 Issued Notice of Compliance
Acalabrutinib Antineoplastic agents 214504 2018-04 2019-08 Issued Notice of Compliance
Acetaminophen Analgesics 209478 2018-02 2018-11 Issued Notice of Compliance
Acetylsalicylic acid, atorvastatin calcium, ramipril Cardiac therapy 234460 2020-02 2021-03 Cancelled by sponsor
Adalimumab Immunosuppressants 203250 2017-04 2018-05 Issued Notice of Compliance
Adalimumab Immunosuppressants 203292 2017-04 2018-05 Issued Notice of Compliance
Adalimumab Immunosuppressants 230637 2019-10 2020-10 Issued Notice of Compliance
Adalimumab Immunosuppressants 217314 2018-11 2020-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 229124 2019-09 2020-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 235685 2020-03 2021-01 Issued Notice of Compliance
Alectinib Antineoplastic agents 189442 2016-02 2016-09 Issued Notice of Compliance under the NOC/c Guidance
Alirocumab Lipid modifying agents 183116 2015-06 2016-04 Issued Notice of Compliance
Alpelisib Antineoplastic agents 226941 2019-05 2020-03 Issued Notice of Compliance
Alvimopan Drugs for constipation 189825 2016-03 2017-03 Cancelled by sponsor
Amifampridine Other nervous system drugs 234655 2020-02 2021-06 Issued Notice of Compliance
Amifampridine phosphate Other nervous system drugs 232685 2020-02 2020-07 Issued Notice of Compliance
Amisulpride Psycholeptics 235705 2020-03 2021-02 Cancelled by sponsor
Amlodipine besylate Calcium channel blockers 211854 2018-07 2019-01 Issued Notice of Compliance
Amoxicillin sodium, clavulanic acid Antibacterials for systemic use 221964 2019-04 2020-01 Issued Notice of Compliance
Anthrax antigen filtrate Vaccines 212387 2018-02 2018-12 Issued Notice of Compliance
Anthrax immunoglobulin (human) Immune sera and immunoglobulins 200446 2017-01 2017-11 Issued Notice of Compliance
Antihemophilic factor (human), Von Willebrand factor (human) Antihemorrhagics 194071 2017-06 2018-05 Issued Notice of Compliance
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 189709 2016-01 2016-11 Issued Notice of Compliance
Antihemophilic factor (recombinant, B-domain deleted, pegylated) Antihemorrhagics 210935 2017-12 2018-10 Issued Notice of Compliance
Antihemophilic factor VIII (Recombinant, B-domain truncated), pegylated Antihemorrhagics 218531 2018-09 2019-07 Issued Notice of Compliance
Apalutamide Endocrine therapy 211942 2018-01 2018-07 Issued Notice of Compliance
Apomorphine hydrochloride Anti-parkinson drugs 217320 2018-08 2020-06 Issued Notice of Compliance
Ataluren Other drugs for disorders of the musculo-skeletal system 186992 2015-09 2016-03 Cancelled by sponsor
Ataluren Other drugs for disorders of the musculo-skeletal system 217349 2018-09 2019-10 Cancelled by sponsor
Atezolizumab Antineoplastic agents 196843 2016-08 2017-04 Issued Notice of Compliance under the NOC/c Guidance
Avelumab Antineoplastic agents 204052 2017-04 2017-12 Issued Notice of Compliance under the NOC/c Guidance
Avelumab Antineoplastic agents 208742 2017-09 2018-05 Issued Notice of Compliance under the NOC/c Guidance
Axicabtagene ciloleucel Antineoplastic agents 218389 2018-08 2019-02 Issued Notice of Compliance
Azacitidine Antineoplastic agents 240668 2020-07 2021-01 Issued Notice of Compliance
Bacillus Calmette-Guerin BCG – Strain Russian BCG-I Immunostimulants 221579 2018-12 2020-12 Issued Notice of Compliance under the NOC/c Guidance
Baloxavir marboxil Antivirals for systemic use 227361 2019-05 2020-02 Issued Notice of Compliance
Baricitinib Antiinflammatory and antirheumatic products 193687 2016-05 2018-08 Issued Notice of Compliance
Belinostat Antineoplastic agents 208886 2017-12 2019-11 Cancelled by sponsor
Benralizumab Immunosuppressants 204008 2017-04 2018-02 Issued Notice of Compliance
Bepotastine besilate Ophthalmologicals 179294 2015-10 2016-07 Issued Notice of Compliance
Betamethasone valerate, fusidic acid Corticosteroids, dermatological preparations 203765 2017-06 2018-04 Issued Notice of Compliance
Betula verrucosa extract Nasal preparations 227270 2019-06 2020-04 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 201427 2017-02 2018-04 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 218183 2018-08 2019-06 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 217524 2018-08 2021-01 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 244450 2020-11 2021-06 Cancelled by sponsor
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 203718 2017-09 2018-07 Issued Notice of Compliance
Bilastine Antihistamines for systemic use 184231 2015-06 2016-04 Issued Notice of Compliance
Binimetinib Antineoplastic agents 237410 2020-05 2021-03 Issued Notice of Compliance
Bisoprolol fumarate Beta blocking agents 203050 2017-07 2019-11 Issued Notice of Compliance
Bisoprolol fumarate Beta blocking agents 231842 2020-05 2020-09 Cancelled by sponsor
Bivalirudin Antithrombotic agents 232423 2019-11 2020-09 Issued Notice of Compliance
Blinatumomab Antineoplastic agents 181723 2015-04 2015-12 Issued Notice of Compliance under the NOC/c Guidance
Botulinum antitoxin, serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins 190645 2016-02 2016-12 Issued Notice of Compliance
Brexpiprazole Psycholeptics 192684 2016-04 2017-02 Issued Notice of Compliance
Brexucabtagene autoleucel Antineoplastic agents 246355 2020-12 2021-06 Issued Notice of Compliance
Brigatinib Antineoplastic agents 210369 2017-11 2018-07 Issued Notice of Compliance under the NOC/c Guidance
Brilliant blue G Ophthalmologicals 232449 2020-03 2021-01 Issued Notice of Compliance
Brivaracetam Antiepileptics 183355 2015-05 2016-03 Issued Notice of Compliance
Brodalumab Immunosuppressants 195317 2016-07 2018-03 Issued Notice of Compliance
Brolucizumab Ophthalmologicals 226224 2019-05 2020-03 Issued Notice of Compliance
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 227232 2019-05 2019-11 Issued Notice of Compliance
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 220876 2019-06 2020-04 Issued Notice of Compliance
Buprenorphine Other nervous system drugs 215660 2018-05 2018-11 Issued Notice of Compliance
Buprenorphine hydrochloride Other nervous system drugs 196428 2016-08 2017-06 Issued Notice of Compliance
Buprenorphine hydrochloride Other nervous system drugs 204746 2017-06 2018-04 Issued Notice of Compliance
Bupropion hydrochloride, naltrexone hydrochloride Antiobesity preparations, excluding diet products 202774 2017-04 2018-02 Issued Notice of Compliance
Burosumab Drugs for treatment of bone diseases 216239 2018-06 2018-12 Issued Notice of Compliance
C1 esterase inhibitor (human) Other hematological agents 198308 2016-11 2017-09 Issued Notice of Compliance
Cabotegravir, rilpivirine Antivirals for systemic use 227315 2019-05 2020-03 Issued Notice of Compliance
Cabozantinib Antineoplastic agents 206230 2017-07 2018-09 Issued Notice of Compliance
Caffeine citrate Psychoanaleptics 225810 2019-05 2020-03 Issued Notice of Compliance
Calcifediol Vitamins 205392 2017-09 2018-07 Issued Notice of Compliance
Canakinumab Immunosuppressants 213303 2018-06 2018-12 Cancelled by sponsor
Caplacizumab Antithrombotic agents 230001 2019-08 2020-02 Issued Notice of Compliance
Carfilzomib Antineoplastic agents 184479 2015-07 2016-01 Issued Notice of Compliance
Cedazuridine, decitabine Antineoplastic agents 234610 2020-01 2020-07 Issued Notice of Compliance
Cefixime Antibacterials for systemic use 189720 2016-05 2017-10 Issued Notice of Compliance
Cemiplimab Antineoplastic agents 218718 2018-08 2019-04 Issued Notice of Compliance under the NOC/c Guidance
Cenegermin Ophthalmologicals 218145 2018-08 2019-02 Issued Notice of Compliance
Cerliponase alfa Other alimentary tract and metabolism products 216539 2018-06 2018-12 Issued Notice of Compliance
Chlormethine Antineoplastic agents 238994 2020-08 2021-06 Issued Notice of Compliance
Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride Blood substitutes and perfusion solutions 223801 2019-06 2020-04 Issued Notice of Compliance
Cidofovir Antivirals for systemic use 200865 2017-04 2018-03 Issued Notice of Compliance
Cinnarizine, dimenhydrinate Other nervous system drugs 195151 2016-09 2018-11 Issued Notice of Non-compliance - Withdrawal
Cladribine Immunosuppressants 200943 2017-02 2017-11 Issued Notice of Compliance
Clozapine Psycholeptics 193638 2016-05 2016-11 Issued Notice of Compliance
Coagulation factor IX (recombinant), pegylated Antihemorrhagics 201114 2017-02 2017-11 Issued Notice of Compliance
Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 199705 2017-05 2018-03 Issued Notice of Compliance
Cobimetinib fumarate Antineoplastic agents 182788 2015-04 2016-02 Issued Notice of Compliance
Crisaborole Other dermatological preparations 206906 2017-08 2018-06 Issued Notice of Compliance
Cyclosporine Ophthalmologicals 194580 2016-08 2018-04 Issued Notice of Non-compliance - Withdrawal
Cyclosporine Ophthalmologicals 215813 2018-07 2018-12 Issued Notice of Compliance
Cyclosporine Ophthalmologicals 234677 2020-04 2021-02 Issued Notice of Compliance
Cysteamine hydrochloride Ophthalmologicals 211635 2018-02 2019-02 Issued Notice of Compliance
Cytarabine, daunorubicin hydrochloride Antineoplastic agents 242743 2020-11 2021-04 Issued Notice of Compliance
Daclizumab Immunosuppressants 190458 2016-02 2016-12 Issued Notice of Compliance
Dacomitinib Antineoplastic agents 214572 2018-05 2019-02 Issued Notice of Compliance
Dalbavancin Antibacterials for systemic use 212390 2018-03 2018-09 Issued Notice of Compliance
Daratumumab Antineoplastic agents 187648 2015-11 2016-06 Issued Notice of Compliance under the NOC/c Guidance
Darolutamide Endocrine therapy 226146 2019-04 2020-02 Issued Notice of Compliance
Darvadstrocel Unassigned 217347 2018-08 2019-06 Cancelled by sponsor
Decitabine Antineoplastic agents 207372 2018-03 2019-01 Issued Notice of Compliance
Decitabine Antineoplastic agents 217663 2018-09 2019-07 Issued Notice of Compliance
Defibrotide Antithrombotic agents 200808 2017-01 2017-07 Issued Notice of Compliance
Dermatophagoides farinae, dermatophagoides pteronyssinus Allergens 208152 2017-09 2020-07 Cancelled by sponsor
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 195186 2016-07 2017-05 Issued Notice of Compliance
Desvenlafaxine Psychoanaleptics 199626 2017-02 2017-08 Issued Notice of Compliance
Dexamethasone sodium phosphate, netilmicin sulfate Ophthalmologicals 212391 2018-02 2019-10 Issued Notice of Compliance
Dinutuximab Antineoplastic agents 212066 2018-02 2018-11 Issued Notice of Compliance
Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic All other non-therapeutic products 220402 2018-11 2019-09 Issued Notice of Compliance
Dolutegravir, lamivudine Antivirals for systemic use 220275 2018-10 2019-08 Issued Notice of Compliance
Dolutegravir sodium, rilpivirine hydrochloride Antivirals for systemic use 206402 2017-07 2018-05 Issued Notice of Compliance
Doravirine Antivirals for systemic use 211293 2017-12 2018-10 Issued Notice of Compliance
Doravirine, lamivudine, tenofovir disoproxil fumarate Antivirals for systemic use 211708 2018-01 2018-11 Issued Notice of Compliance
Dotatate Diagnostic radiopharmaceuticals 218346 2018-09 2019-07 Issued Notice of Compliance
Drospirenone, estetrol monohydrate Sex hormones and modulators of the genital system 236197 2020-05 2021-03 Issued Notice of Compliance
Dupilumab Immunosuppressants 201285 2017-02 2017-11 Issued Notice of Compliance
Durvalumab Antineoplastic agents 202953 2017-03 2017-11 Issued Notice of Compliance under the NOC/c Guidance
Durvalumab Antineoplastic agents 208834 2017-09 2018-05 Issued Notice of Compliance under the NOC/c Guidance
Edaravone Other nervous system drugs 214391 2018-04 2018-10 Issued Notice of Compliance
Edoxaban Antithrombotic agents 187363 2015-12 2016-11 Issued Notice of Compliance
Elagolix Sex hormones and modulators of the genital system 209513 2017-12 2018-10 Issued Notice of Compliance
Elbasvir, grazoprevir Antivirals for systemic use 185866 2015-07 2016-01 Issued Notice of Compliance
Elexacaftor, ivacaftor, tezacaftor Other respiratory system products 246955 2020-12 2021-06 Issued Notice of Compliance
Eliglustat tartrate Other alimentary tract and metabolism products 183050 2015-05 2017-04 Issued Notice of Compliance
Elotuzumab Antineoplastic agents 188144 2015-12 2016-06 Issued Notice of Compliance
Eluxadoline Drugs for functional gastrointestinal disorders 190162 2016-04 2017-01 Issued Notice of Compliance
Emapalumab Immunosuppressants 237121 2020-05 2021-02 Cancelled by sponsor
Emicizumab Antihemorrhagics 212635 2018-02 2018-08 Issued Notice of Compliance
Enasidenib mesylate Antineoplastic agents 217033 2018-07 2019-02 Issued Notice of Compliance under the NOC/c Guidance
Encorafenib Antineoplastic agents 237413 2020-05 2021-03 Issued Notice of Compliance
Encorafenib Antineoplastic agents 238571 2020-06 2021-03 Issued Notice of Compliance
Enoxaparin sodium Antithrombotic agents 233058 2019-12 2020-10 Issued Notice of Compliance
Enoxaparin sodium Antithrombotic agents 233987 2020-01 2020-11 Issued Notice of Compliance
Enoxaparin sodium Antithrombotic agents 231767 2019-11 2020-12 Issued Notice of Compliance
Entrectinib Antineoplastic agents 227517 2019-06 2020-02 Issued Notice of Compliance under the NOC/c Guidance
Entrectinib Antineoplastic agents 228159 2019-07 2020-05 Issued Notice of Compliance
Eptinezumab Analgesics 233288 2020-03 2021-01 Issued Notice of Compliance
Erdafitinib Antineoplastic agents 224529 2019-03 2019-10 Issued Notice of Compliance under the NOC/c Guidance
Erenumab Analgesics 208607 2017-10 2018-08 Issued Notice of Compliance
Ertugliflozin pidolate Drugs used in diabetes 204724 2017-07 2018-05 Issued Notice of Compliance
Ertugliflozin pidolate, metformin hydrochloride Drugs used in diabetes 201005 2017-08 2018-05 Issued Notice of Compliance
Ertugliflozin pidolate, sitagliptin phosphate monohydrate Drugs used in diabetes 201006 2017-07 2018-05 Issued Notice of Compliance
Esketamine hydrochloride Psychoanaleptics 222855 2019-01 2020-05 Issued Notice of Compliance
Estradiol hemihydrate Sex hormones and modulators of the genital system 223938 2019-10 2020-08 Issued Notice of Compliance
Estradiol hemihydrate, progesterone Sex hormones and modulators of the genital system 224010 2019-11 2020-09 Issued Notice of Compliance
Estriol, lactobacillus acidophilus Sex hormones and modulators of the genital system 203472 2017-06 2019-01 Issued a Notice of Deficiency - Withdrawal
Etanercept Immunosuppressants 193864 2016-06 2017-04 Issued Notice of Compliance
Etomidate Anesthetics 231245 2019-12 2020-07 Issued Notice of Compliance
Etonogestrel Sex hormones and modulators of the genital system 226314 2019-05 2020-05 Issued Notice of Compliance
Fedratinib dihydrochloride monohydrate Antineoplastic agents 229866 2019-10 2020-07 Issued Notice of Compliance
Ferric pyrophosphate citrate Antianemic preparations 239850 2020-06 2021-04 Issued Notice of Compliance
Fibrinogen (human) Antihemorrhagics 195870 2016-08 2017-06 Issued Notice of Compliance
Fibrinogen (human), thrombin (human) Antihemorrhagics 239016 2020-05 2021-03 Issued Notice of Compliance
Filgotinib Immunosuppressants 235219 2020-04 2021-01 Cancelled by sponsor
Filgrastim (r-metHuG-CSF) Immunostimulants 212016 2018-02 2019-08 Cancelled by sponsor
Filgrastim (r-metHuG-CSF) Immunostimulants 214080 2018-04 2020-04 Issued Notice of Compliance
Flibanserin Other gynecologicals 189352 2016-04 2018-02 Issued Notice of Compliance
Florbetaben (18F) Diagnostic radiopharmaceuticals 193105 2016-04 2017-02 Issued Notice of Compliance
Fluocinolone acetonide Ophthalmologicals 201510 2017-02 2018-11 Issued Notice of Compliance
Fluorouracil Antineoplastic agents 211768 2018-04 2019-02 Issued Notice of Compliance
Fluoxetine hydrochloride Psychoanaleptics 198520 2016-12 2017-06 Issued Notice of Compliance
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 204880 2017-06 2018-04 Issued Notice of Compliance
Fluticasone propionate Drugs for obstructive airway diseases 197873 2016-10 2017-08 Issued Notice of Compliance
Fluticasone proprionate, salmeterol xinafoate Drugs for obstructive airway diseases 197974 2016-11 2018-04 Issued Notice of Compliance
Follitropin delta Sex hormones and modulators of the genital system 188743 2016-01 2018-03 Issued Notice of Compliance
Formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 201306 2017-02 2018-03 Issued Notice of Compliance
Foscarnet sodium Antivirals for systemic use 233046 2019-12 2020-10 Issued Notice of Compliance
Fosfomycin sodium Antibacterials for systemic use 219662 2018-11 2019-05 Issued Notice of Compliance
Fostamatinib disodium Antihemorrhagics 232078 2020-01 2020-11 Issued Notice of Compliance
Fremanezumab Analgesics 226828 2019-06 2020-04 Issued Notice of Compliance
Gadoteric acid Contrast media 186333 2015-12 2016-11 Issued Notice of Compliance
Galcanezumab Analgesics 219521 2018-10 2019-07 Issued Notice of Compliance
Gallium (68Ga) chloride Diagnostic radiopharmaceuticals 221824 2019-04 2019-11 Issued Notice of Compliance
Gallium (68Ga) chloride, germanium (68Ge) chloride Diagnostic radiopharmaceuticals 227804 2019-10 2020-08 Issued Notice of Compliance
Gemtuzumab ozogamicin Antineoplastic agents 223091 2019-02 2019-11 Issued Notice of Compliance
Gilteritinib fumarate Antineoplastic agents 227918 2019-06 2019-12 Issued Notice of Compliance
Givosiran Bile and liver therapy 237194 2020-04 2020-10 Issued Notice of Compliance
Glasdegib Antineoplastic agents 225793 2019-07 2020-04 Issued Notice of Compliance
Glecaprevir, pibrentasvir Antivirals for systemic use 202233 2017-02 2017-08 Issued Notice of Compliance
Glucagon Pancreatic hormones 220839 2018-11 2019-09 Issued Notice of Compliance
Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine Blood substitutes and perfusion solutions 231585 2020-03 2020-12 Issued Notice of Compliance
Glycopyrrolate Drugs for functional gastrointestinal disorders 197038 2017-01 2017-10 Issued Notice of Compliance
Glycopyrronium bromide, indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 228353 2019-09 2020-07 Issued Notice of Compliance
Guselkumab Immunosuppressants 200590 2017-01 2017-11 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines 200726 2017-05 2019-03 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 203436 2017-04 2018-02 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 222669 2019-01 2019-11 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 234113 2020-01 2020-11 Cancelled by sponsor
Haemagglutinin, neuraminidase antigen Vaccines 235556 2020-03 2021-01 Issued Notice of Compliance
Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations 212718 2018-05 2020-06 Issued Notice of Compliance
Hemin Other alimentary tract and metabolism 212276 2018-01 2018-07 Issued Notice of Compliance
Human heterologous liver cells Other alimentary tract and metabolism products 205160 2017-06 2018-07 Cancelled by sponsor
Hydrochlorothiazide, zofenopril calcium Agents acting on the renin-angiotensin system 212396 2018-06 2019-06 Cancelled by sponsor
Hydrogen peroxide Other dermatological preparations 216854 2018-12 2019-08 Cancelled by sponsor
Icosapent ethyl Lipid modifying agents 227235 2019-07 2019-12 Issued Notice of Compliance
Idarucizumab All other therapeutic products 182503 2015-05 2016-04 Issued Notice of Compliance under the NOC/c Guidance
Idecabtagene vicleucel Antineoplastic agents 244266 2020-10 2021-05 Issued Notice of Compliance under the NOC/c Guidance
Immunoglobulin (human) Immune sera and immunoglobulins 194291 2016-10 2017-08 Issued Notice of Compliance
Immunoglobulin (human) Immune sera and immunoglobulins 226576 2019-06 2019-12 Issued Notice of Compliance
Immunoglobulin G (human) Immune sera and immunoglobulins 202924 2017-04 2018-02 Issued Notice of Compliance
Indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 227987 2019-07 2020-05 Issued Notice of Compliance
Infliximab Immunosuppressants 226189 2019-05 2020-03 Issued Notice of Compliance
Inotersen sodium Other nervous system drugs 214274 2018-04 2018-10 Issued Notice of Compliance
Inotuzumab ozogamicin Antineoplastic agents 204077 2017-05 2018-03 Issued Notice of Compliance
Insulin aspart Drugs used in diabetes 226573 2019-12 2020-10 Issued Notice of Compliance
Insulin degludec Drugs used in diabetes 198124 2016-10 2017-08 Issued Notice of Compliance
Insulin degludec, liraglutide Drugs used in diabetes 194513 2017-06 2018-04 Issued Notice of Compliance
Insulin glargine Drugs used in diabetes 202772 2017-04 2019-02 Cancelled by sponsor
Insulin glargine, lixisenatide Drugs used in diabetes 207006 2017-09 2018-07 Issued Notice of Compliance
Insulin injection human biosynthetic Drugs used in diabetes 189076 2016-09 2017-07 Issued Notice of Compliance
Insulin lispro Drugs used in diabetes 200792 2017-01 2017-11 Issued Notice of Compliance
Iodine Contrast media 196107 2016-09 2017-07 Issued Notice of Compliance
Ioflupane (123I) Diagnostic radiopharmaceuticals 201481 2017-02 2017-12 Issued Notice of Compliance
Iron dextran Antianemic preparations 189897 2016-05 2017-06 Cancelled by sponsor
Iron isomaltoside 1000 Antianemic preparations 193890 2016-07 2018-06 Issued Notice of Compliance
Isatuximab Antineoplastic agents 229245 2019-07 2020-04 Issued Notice of Compliance
Isavuconazonium sulfate Antimycotics for systemic use 208919 2018-02 2018-12 Issued Notice of Compliance
Ivacaftor, tezacaftor Other respiratory system products 211292 2017-12 2018-06 Issued Notice of Compliance
Ivermectin Anthelmintics 211000 2017-12 2018-09 Issued Notice of Compliance
Ixazomib citrate Antineoplastic agents 190498 2016-02 2016-08 Issued Notice of Compliance
Ixekizumab Immunosuppressants 184993 2015-07 2016-05 Issued Notice of Compliance
Lanadelumab Other hematological agents 213920 2018-03 2018-09 Issued Notice of Compliance
Larotrectinib Antineoplastic agents 219998 2018-11 2019-07 Issued Notice of Compliance under the NOC/c Guidance
Lasmiditan Analgesics 236369 2020-04 2021-01 Cancelled by sponsor
Latanoprostene bunod Ophthalmologicals 211732 2018-03 2018-12 Issued Notice of Compliance
Lefamulin acetate Antibacterials for systemic use 233292 2020-01 2020-07 Issued Notice of Compliance
Lemborexant Psycholeptics 231286 2020-01 2020-11 Issued Notice of Compliance
Letermovir Antivirals for systemic use 204165 2017-05 2017-11 Issued Notice of Compliance
Levetiracetam Antiepileptics 213656 2018-09 2019-07 Issued Notice of Compliance
Levothyroxine sodium Thyroid therapy 232047 2020-01 2020-11 Issued Notice of Compliance
Lifitegrast Ophthalmologicals 199810 2016-12 2017-12 Issued Notice of Compliance
Lixisenatide Drugs used in diabetes 193862 2016-06 2017-05 Issued Notice of Compliance
Lonoctocog alfa Antihemorrhagics 190891 2016-02 2016-12 Issued Notice of Compliance
Lorcaserin hydrochloride Antiobesity preparations, excluding diet products 198689 2016-11 2018-02 Cancelled by sponsor
Lorlatinib Antineoplastic agents 215733 2018-06 2019-02 Issued Notice of Compliance under the NOC/c Guidance
Luspatercept Antianemic preparations 236441 2020-03 2020-09 Issued Notice of Compliance
Luspatercept Antianemic preparations 236625 2020-04 2021-02 Issued Notice of Compliance
Lutetium (177Lu) oxodotretotide Therapeutic radiopharmaceuticals 217184 2018-07 2019-01 Issued Notice of Compliance
Mannitol Diagnostic agents 217446 2018-08 2019-06 Issued Notice of Compliance
Mecasermin Pituitary, hypothalamic hormones and analogues 235023 2020-02 2020-12 Issued Notice of Compliance
Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate Vaccines 233632 2020-01 2020-10 Issued Notice of Compliance
Mercaptamine bitartrate Other alimentary tract and metabolism products 191347 2016-03 2017-06 Issued Notice of Compliance
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 204605 2017-05 2018-03 Issued Notice of Compliance
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 198475 2017-02 2020-08 Cancelled by sponsor
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 194646 2016-09 2021-05 Issued Notice of Compliance
Methoxyflurane Analgesics 204879 2017-06 2018-04 Issued Notice of Compliance
Methylene blue Diagnostic agents 219788 2018-10 2021-05 Issued Notice of Non-compliance - Withdrawal
Midostaurin Antineoplastic agents 201101 2017-01 2017-07 Issued Notice of Compliance
Migalastat hydrochloride Other alimentary tract and metabolism products 196956 2016-11 2017-09 Issued Notice of Compliance
Mometasone furoate Corticosteroids, dermatological preparations 199704 2017-09 2019-10 Cancelled by sponsor
Naloxone hydrochloride All other therapeutic products 193199 2016-04 2016-10 Issued Notice of Compliance
Naloxone hydrochloride dihydrate All other therapeutic products 211970 2018-01 2019-06 Cancelled by sponsor
Naproxen sodium, sumatriptan succinate Analgesics 225848 2019-05 2020-02 Issued Notice of Compliance
Necitumumab Antineoplastic agents 193689 2016-05 2017-03 Issued Notice of Compliance
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines 195550 2016-07 2017-10 Issued Notice of Compliance
Neratinib maleate Antineoplastic agents 218224 2018-09 2019-07 Issued Notice of Compliance
Netupitant, palonosetron hydrochloride Antiemetics and antinauseants 196495 2016-12 2017-09 Issued Notice of Compliance
Nicardipine hydrochloride Calcium channel blockers 216257 2018-07 2020-04 Issued Notice of Non-compliance - Withdrawal
Niraparib Antineoplastic agents 216792 2018-09 2019-06 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 190564 2016-03 2016-09 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 193226 2016-07 2016-12 Issued Notice of Compliance
Nitisinone Other alimentary tract and metabolism products 193770 2016-05 2016-11 Issued Notice of Compliance
Nusinersen Other drugs for disorders of the musculo-skeletal systemOther 200070 2016-12 2017-06 Issued Notice of Compliance
Obeticholic acid Bile and liver therapy 198418 2016-10 2017-05 Issued Notice of Compliance under the NOC/c Guidance
Obiltoxaximab Immune sera and immunoglobulins 230825 2019-10 2020-07 Issued Notice of Compliance
Ocrelizumab Immunosuppressants 198094 2016-10 2017-08 Issued Notice of Compliance
Ocrelizumab Immunosuppressants 197969 2016-10 2018-02 Issued Notice of Compliance under the NOC/c Guidance
Ofatumumab Antineoplastic agents 237346 2020-05 2021-01 Issued Notice of Compliance
Olaparib Antineoplastic agents 182823 2015-06 2016-04 Issued Notice of Compliance under the NOC/c Guidance
Olaratumab Antineoplastic agents 203478 2017-04 2017-11 Issued Notice of Compliance under the NOC/c Guidance
Onasemnogene abeparvovec Other drugs for disorders of the musculo-skeletal system 239719 2020-06 2020-12 Issued Notice of Compliance
Osimertinib Antineoplastic agents 188171 2015-11 2016-07 Issued Notice of Compliance under the NOC/c Guidance
Oxycodone Analgesics 198865 2016-11 2018-07 Cancelled by sponsor
Ozanimod hydrochloride Immunosuppressants 232761 2019-12 2020-10 Issued Notice of Compliance
Ozenoxacin Antibiotics and chemotherapy for dermatological use 192925 2016-07 2017-05 Issued Notice of Compliance
Panobinostat Antineoplastic agents 187504 2015-11 2016-06 Cancelled by sponsor
Patiromer sorbitex calcium All other therapeutic products 210368 2017-12 2018-10 Issued Notice of Compliance
Patisiran Other nervous system drugs 221896 2018-12 2019-06 Issued Notice of Compliance
Pegaspargase Antineoplastic agents 189795 2016-05 2017-02 Issued Notice of Compliance
Pegfilgrastim Immunostimulants 204841 2017-06 2018-04 Issued Notice of Compliance
Pegfilgrastim Immunostimulants 200807 2017-01 2018-12 Issued Notice of Compliance
Pegfilgrastim Immunostimulants 220445 2019-05 2020-04 Issued Notice of Compliance
Pegfilgrastim Immunostimulants 233373 2020-01 2020-10 Issued Notice of Compliance
Peramivir Antivirals for systemic use 191280 2016-03 2017-01 Issued Notice of Compliance
Perindopril arginine Agents acting on the renin-angiotensin system 201189 2017-08 2018-03 Issued Notice of Compliance
Pertuzumab, trastuzumab Antineoplastic agents 237402 2020-05 2021-03 Issued Notice of Compliance
Pitolisant Other nervous system drugs 238175 2020-05 2021-05 Issued Notice of Compliance
Plecanatide Drugs for constipation 215288 2018-12 2019-10 Issued Notice of Compliance
Polatuzumab vedotin Antineoplastic agents 232303 2019-11 2020-07 Issued Notice of Compliance under the NOC/c Guidance
Ponesimod Immunosuppressants 239537 2020-07 2021-04 Issued Notice of Compliance
PrabotulinumtoxinA Muscle relaxants 208364 2017-10 2018-08 Issued Notice of Compliance
Pralatrexate Antineoplastic agents 207545 2017-11 2018-10 Issued Notice of Compliance under the NOC/c Guidance
Pralsetinib Antineoplastic agents 243731 2020-11 2021-06 Issued Notice of Compliance under the NOC/c Guidance
Prasterone Anabolic agents for systemic use 198822 2016-12 2019-11 Issued Notice of Compliance
Progesterone Sex hormones and modulators of the genital system 211548 2018-02 2018-08 Issued Notice of Compliance
Progesterone Sex hormones and modulators of the genital system 239820 2020-07 2021-04 Issued Notice of Compliance
Propiverine hydrochloride Urologicals 188323 2016-03 2017-01 Issued Notice of Compliance
Rabies immunoglobulin, human Immune sera and immunoglobulins 211541 2018-01 2018-11 Issued Notice of Compliance
Ranolazine Cardiac therapy 239943 2020-07 2020-12 Issued Notice of Compliance
Ravulizumab Immunosuppressants 217955 2018-11 2019-08 Issued Notice of Compliance
Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) Antihemorrhagics 180793 2015-04 2016-01 Issued Notice of Compliance
Recombinant influenza strain A H1N1 HA protein, recombinant influenza strain A H3N2 HA protein, recombinant influenza strain B (Victoria lineage) HA protein, recombinant influenza strain B (Yamagata lineage) HA protein Vaccines 235672 2020-03 2021-01 Issued Notice of Compliance
Remdesivir Antivirals for systemic use 240551 2020-07 2020-07 Issued Notice of Compliance under the NOC/c Guidance
Reslizumab Immunosuppressants 185873 2015-09 2016-07 Issued Notice of Compliance
Ribociclib Antineoplastic agents 203884 2017-05 2018-03 Issued Notice of Compliance
Ripretinib Antineoplastic agents 234688 2020-03 2020-06 Issued Notice of Compliance
Risankizumab Immunosuppressants 215753 2018-06 2019-04 Issued Notice of Compliance
Risdiplam Other drugs for disorders of the musculo-skeletal system 242373 2020-10 2021-04 Issued Notice of Compliance
Risperidone Psycholeptics 233331 2020-01 2020-11 Issued Notice of Compliance
Rituximab Antineoplastic agents 207702 2017-09 2019-03 Cancelled by sponsor
Rituximab Antineoplastic agents 208107 2017-09 2019-03 Cancelled by sponsor
Rituximab Antineoplastic agents 208204 2017-09 2019-04 Issued Notice of Compliance
Rituximab Antineoplastic agents 224672 2019-03 2019-04 Cancelled by sponsor
Rituximab Antineoplastic agents 214058 2018-04 2020-04 Issued Notice of Compliance
Rituximab Antineoplastic agents 224164 2019-03 2020-05 Issued Notice of Compliance
Rituximab Antineoplastic agents 237814 2020-05 2021-03 Issued Notice of Compliance
Romosozumab Drugs for treatment of bone diseases 197713 2016-10 2019-06 Issued Notice of Compliance
Rupatadine fumarate Antihistamines for systemic use 186488 2015-09 2016-07 Issued Notice of Compliance
Safinamide Anti-parkinson drugs 207115 2018-03 2019-01 Issued Notice of Compliance
Salbutamol sulfate Drugs for obstructive airway diseases 189577 2016-11 2017-11 Issued Notice of Compliance
Sarilumab Immunosuppressants 191745 2016-03 2017-01 Issued Notice of Compliance
Satralizumab Immunosuppressants 233642 2019-12 2020-06 Issued Notice of Compliance
Sebelipase alfa Other alimentary tract and metabolism products 204085 2017-04 2017-12 Issued Notice of Compliance under the NOC/c Guidance
Selpercatinib Antineoplastic agents 243748 2020-10 2021-06 Issued Notice of Compliance under the NOC/c Guidance
Semaglutide Drugs used in diabetes 202059 2017-03 2018-01 Issued Notice of Compliance
Semaglutide Drugs used in diabetes 226906 2019-06 2020-03 Issued Notice of Compliance
Siponimod Immunosuppressants 223225 2019-02 2020-02 Issued Notice of Compliance
Sirukumab Immunosuppressants 205568 2017-06 2017-10 Cancelled by sponsor
Sodium chloride, sodium citrate Blood substitutes and perfusion solutions 225953 2019-05 2020-03 Issued Notice of Compliance
Sodium pertechnetate Tc-99m Diagnostic radiopharmaceuticals 231915 2020-01 2020-11 Issued Notice of Compliance
Sodium zirconium cyclosilicate All other therapeutic products 218799 2018-09 2019-07 Issued Notice of Compliance
Sofosbuvir, velpatasvir Antivirals for systemic use 190521 2016-01 2016-07 Issued Notice of Compliance
Sofosbuvir, velpatasvir, voxilaprevir Antivirals for systemic use 202324 2017-02 2017-08 Issued Notice of Compliance
Solriamfetol hydrochloride Psychoanaleptics 237511 2020-07 2021-05 Issued Notice of Compliance
Sonidegib Antineoplastic agents 229407 2019-08 2020-06 Issued Notice of Compliance
Sotagliflozin Drugs used in diabetes 217853 2018-08 2019-06 Cancelled by sponsor
Sucroferric oxyhydroxide All other therapeutic products 201492 2017-02 2018-01 Issued Notice of Compliance
Sugammadex All other therapeutic products 180385 2015-04 2016-02 Issued Notice of Compliance
Suvorexant Psycholeptics 196367 2016-08 2018-11 Issued Notice of Compliance
Tacrolimus Immunosuppressants 209210 2018-04 2019-02 Issued Notice of Compliance
Tafamidis meglumine Other nervous system drugs 228368 2019-07 2020-01 Issued Notice of Compliance
Talazoparib Antineoplastic agents 220584 2018-11 2019-09 Issued Notice of Compliance
Telotristat etiprate Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 208730 2017-12 2018-10 Issued Notice of Compliance
Tenapanor Drugs for constipation 224850 2019-06 2020-04 Issued Notice of Compliance
Tenofovir alafenamide hemifumarate Antivirals for systemic use 193066 2016-07 2017-05 Issued Notice of Compliance
Tepotinib Antineoplastic agents 242300 2020-10 2021-05 Issued Notice of Compliance under the NOC/c Guidance
Teriparatide Calcium homeostasis 215409 2018-06 2020-01 Issued Notice of Compliance
Tibolone Sex hormones and modulators of the genital system 206099 2017-10 2019-05 Issued Notice of Compliance
Tildrakizumab Immunosuppressants 224036 2019-02 2021-05 Issued Notice of Compliance
Tipiracil hydrochloride, trifluridine Antineoplastic agents 205852 2017-07 2018-01 Issued Notice of Compliance
Tisagenlecleucel-T Antineoplastic agents 213547 2018-03 2018-09 Issued Notice of Compliance
Tisagenlecleucel-T Antineoplastic agents 213698 2018-03 2018-09 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 204579 2017-06 2019-05 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 212140 2018-02 2019-08 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 210238 2017-11 2019-09 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 208836 2017-10 2020-02 Issued Notice of Compliance
Trastuzumab deruxtecan Antineoplastic agents 242104 2020-08 2021-04 Issued Notice of Compliance under the NOC/c Guidance
Treosulfan Antineoplastic agents 244137 2020-12 2021-06 Issued Notice of Compliance
Triamcinolone hexacetonide Corticosteroids for systemic use 201546 2017-02 2017-12 Issued Notice of Compliance
Trientine hydrochloride Other alimentary tract and metabolism products 228708 2019-11 2020-09 Issued Notice of Compliance
Trientine hydrochloride All other therapeutic products 237287 2020-06 2021-04 Issued Notice of Compliance
Trifarotene Anti-acne preparations 221945 2019-01 2019-11 Issued Notice of Compliance
Triheptanoin Other alimentary tract and metabolism 242196 2020-08 2021-02 Issued Notice of Compliance
Tucatinib Antineoplastic agents 235295 2020-02 2020-06 Issued Notice of Compliance
Upadacitinib Immunosuppressants 223734 2019-03 2019-12 Issued Notice of Compliance
Varicella-zoster virus glycoprotein E (GE) Vaccines 200244 2016-12 2017-10 Issued Notice of Compliance
Venetoclax Antineoplastic agents 190761 2016-02 2016-09 Issued Notice of Compliance under the NOC/c Guidance
Vernakalant hydrochloride Cardiac therapy 190817 2016-05 2017-03 Issued Notice of Compliance
Vitamin D3 Vitamins 219321 2019-01 2021-02 Issued Notice of Compliance
Volanesorsen Lipid modifying agents 209280 2017-11 2018-11 Issued Notice of Non-compliance - Withdrawal
Vonicog alfa Antihemorrhagics 213188 2018-03 2019-01 Issued Notice of Compliance
Voretigene neparvovec Ophthalmologicals 233097 2019-12 2020-10 Issued Notice of Compliance
Zanubrutinib Antineoplastic agents 242748 2020-09 2021-03 Issued Notice of Compliance
Zofenopril calcium Agents acting on the renin-angiotensin system 212392 2018-06 2019-06 Cancelled by sponsor
Footnote 1

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

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