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

Submissions formerly under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Submission Control Number Year, Month Submission was Accepted into Review Year, Month Submission Concluded Outcome of SubmissionFootnote a
Abacavir sulfate, dolutegravir sodium, lamivudine Antivirals for systemic use 208070 2017-08 2017-10 Issued Notice of Compliance
Abatacept Immunosuppressants 204313 2017-05 2018-03 Issued Notice of Compliance
Abiraterone acetate Endocrine therapy 207915 2017-08 2018-02 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 202245 2017-03 2017-12 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 204299 2017-05 2018-03 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 206921 2017-08 2018-04 Issued Notice of Compliance
AbobotulinumtoxinA Muscle relaxants 236999 2020-04 2021-02 Issued Notice of Compliance
Acalabrutinib Antineoplastic agents 231228 2019-10 2019-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 197529 2016-09 2017-07 Issued Notice of Compliance
Adalimumab Immunosuppressants 201423 2017-02 2017-12 Issued Notice of Compliance
Adalimumab Immunosuppressants 212133 2018-02 2018-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 213550 2018-03 2019-01 Issued Notice of Compliance
Adalimumab Immunosuppressants 219453 2018-10 2020-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 234183 2019-12 2020-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 234258 2020-01 2020-11 Issued Notice of Compliance
Adalimumab Immunosuppressants 239280 2020-06 2021-04 Issued Notice of Compliance
Adalimumab Immunosuppressants 244618 2020-11 2021-09 Issued Notice of Compliance
Afatinib dimaleate Antineoplastic agents 209785 2017-12 2018-09 Issued Notice of Compliance
Alectinib Antineoplastic agents 210816 2017-12 2018-06 Issued Notice of Compliance
Alemtuzumab Immunosuppressants 239220 2020-07 2021-04 Issued Notice of Compliance
Alirocumab Lipid modifying agents 219669 2018-10 2019-07 Issued Notice of Compliance
Alpha 1-proteinase inhibitor (human) Antihemorrhagics 205855 2017-06 2017-06 Issued Notice of Compliance
Anakinra Immunosuppressants 195649 2016-07 2017-05 Issued Notice of Compliance
Anthrax antigen filtrate Vaccines 234257 2020-01 2020-11 Issued Notice of Compliance
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 211971 2018-01 2018-11 Issued Notice of Compliance
Apalutamide Endocrine therapy 228077 2019-06 2019-12 Issued Notice of Compliance
Apixaban Antithrombotic agents 198842 2016-11 2018-10 Issued Notice of Compliance
Apremilast Immunosuppressants 233030 2019-12 2020-08 Issued Notice of Compliance
Aripiprazole Psycholeptics 200292 2017-01 2017-11 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 205038 2017-06 2018-04 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 217324 2018-07 2019-05 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 223753 2019-02 2019-08 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 223911 2019-02 2019-09 Issued Notice of Compliance under the NOC/c Guidance
Atezolizumab Antineoplastic agents 226905 2019-06 2020-04 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 235450 2020-02 2020-08 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 237371 2020-05 2021-03 Issued Notice of Compliance
Avelumab Antineoplastic agents 225974 2019-04 2019-11 Issued Notice of Compliance under the NOC/c Guidance
Avelumab Antineoplastic agents 226954 2019-06 2020-06 Cancelled by sponsor
Avelumab Antineoplastic agents 240024 2020-06 2020-12 Issued Notice of Compliance
Azelastine hydrochloride, fluticasone propionate Nasal preparations 221498 2018-12 2019-10 Issued Notice of Compliance
Bazedoxifene acetate, conjugated estrogens Sex hormones and modulators of the genital system 210469 2017-11 2018-09 Issued Notice of Compliance
Belimumab Immunosuppressants 243390 2020-10 2021-07 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 207259 2017-08 2018-06 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 218844 2018-09 2019-06 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 230254 2019-09 2020-02 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 232977 2019-11 2021-01 Issued Notice of Compliance
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 226658 2019-05 2020-03 Issued Notice of Compliance
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 240953 2020-07 2021-05 Issued Notice of Compliance
Bilastine Antihistamines for systemic use 241318 2020-10 2021-08 Issued Notice of Compliance
Blinatumomab Antineoplastic agents 197615 2016-09 2017-04 Issued Notice of Compliance under the NOC/c Guidance
Blinatumomab Antineoplastic agents 204154 2017-05 2018-03 Issued Notice of Compliance
Blinatumomab Antineoplastic agents 210780 2017-12 2019-12 Issued Notice of Compliance under the NOC/c Guidance
Bosutinib Antineoplastic agents 211317 2018-02 2018-12 Issued Notice of Compliance
Brentuximab vedotin Antineoplastic agents 213996 2018-04 2018-12 Issued Notice of Compliance
Brentuximab vedotin Antineoplastic agents 216513 2018-07 2019-05 Issued Notice of Compliance
Brentuximab vedotin Antineoplastic agents 227030 2019-05 2019-11 Issued Notice of Compliance
Brexpiprazole Psycholeptics 205854 2017-07 2019-02 Issued Notice of Compliance
Brigatinib Antineoplastic agents 237680 2020-05 2021-03 Issued Notice of Compliance
Brivaracetam Antiepileptics 226734 2019-05 2020-03 Issued Notice of Compliance
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 218994 2018-09 2020-03 Cancelled by sponsor
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 238101 2020-05 2021-03 Issued Notice of Compliance
Budesonide, formoterol fumarate dihydrate Drugs for obstructive airway diseases 220998 2018-11 2019-09 Issued Notice of Compliance
Burosumab Drugs for the treatment of bone diseases 229313 2019-08 2020-06 Issued Notice of Compliance
Burosumab Drugs for treatment of bone diseases 249112 2021-03 2021-08 Issued Notice of Compliance
C1 esterase inhibitor (human) Other hematological agents 197440 2016-09 2017-03 Issued Notice of Compliance
Cabozantinib Antineoplastic agents 221859 2018-12 2019-10 Issued Notice of Compliance
Cabozantinib Antineoplastic agents 222733 2019-01 2019-11 Issued Notice of Compliance
Canagliflozin Drugs used in diabetes 194762 2016-06 2017-04 Issued Notice of Compliance
Canagliflozin Drugs used in diabetes 210676 2017-12 2018-10 Issued Notice of Compliance
Canagliflozin Drugs used in diabetes 229188 2019-08 2020-01 Issued Notice of Compliance
Canagliflozin, metformin hydrochloride Drugs used in diabetes 210969 2017-12 2018-10 Issued Notice of Compliance
Canagliflozin, metformin hydrochloride Drugs used in diabetes 232307 2019-11 2020-08 Issued Notice of Compliance
Canakinumab Immunosuppressants 195617 2016-07 2017-01 Issued Notice of Compliance
Canakinumab Immunosuppressants 237113 2020-04 2021-02 Issued Notice of Compliance
Carbetocin Pituitary and hypothalamic hormones and analogues 225949 2019-05 2020-02 Issued Notice of Compliance
Carfilzomib Antineoplastic agents 237196 2020-04 2021-01 Issued Notice of Compliance
Carglumic acid Other alimentary tract and metabolism products 227936 2019-06 2020-11 Issued Notice of Compliance
Ceftolozane, tazobactam sodium Antibacterials for systemic use 224729 2019-03 2019-08 Issued Notice of Compliance
Certolizumab pegol Immunosuppressants 209082 2017-10 2018-08 Issued Notice of Compliance
Certolizumab pegol Immunosuppressants 222049 2019-01 2019-11 Issued Notice of Compliance
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 195789 2016-07 2017-05 Issued Notice of Compliance
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 207251 2017-08 2018-06 Issued Notice of Compliance
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 219784 2018-10 2019-07 Issued Notice of Compliance
Collagenase clostridium histolyticum Other drugs for disorders of the musculo-skeletal system 202488 2017-03 2018-01 Issued Notice of Compliance
Corynebacterium diphtheriae crm-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F Vaccines 216208 2018-06 2019-04 Issued Notice of Compliance
Crisaborole Other dermatological preparations 240171 2020-07 2021-05 Issued Notice of Compliance
Crizotinib Antineoplastic agents 198322 2016-11 2017-08 Issued Notice of Compliance
Dabrafenib Antineoplastic agents 199381 2016-11 2017-05 Issued Notice of Compliance
Dabrafenib Antineoplastic agents 210753 2017-11 2018-05 Issued Notice of Compliance
Dabrafenib Antineoplastic agents 213581 2018-03 2018-09 Issued Notice of Compliance
Dapagliflozin Drugs used in diabetes 217312 2018-06 2019-04 Issued Notice of Compliance
Dapagliflozin propanediol Drugs used in diabetes 227213 2019-06 2020-04 Issued Notice of Compliance
Dapagliflozin propanediol Drugs used in diabetes 234304 2020-01 2020-06 Issued Notice of Compliance
Dapagliflozin propanediol Drugs used in diabetes 248367 2021-02 2021-08 Issued Notice of Compliance
Dapagliflozin, metformin hydrochloride Drugs used in diabetes 228055 2019-07 2020-04 Issued Notice of Compliance
Daptomycin Antibacterials for systemic use 214792 2018-05 2019-02 Issued Notice of Compliance
Daratumumab Antineoplastic agents 198647 2016-10 2017-04 Issued Notice of Compliance
Daratumumab Antineoplastic agents 212559 2018-01 2018-11 Issued Notice of Compliance
Daratumumab Antineoplastic agents 226512 2019-05 2019-10 Issued Notice of Compliance
Daratumumab Antineoplastic agents 234407 2020-01 2020-11 Issued Notice of Compliance
Daratumumab Antineoplastic agents 244119 2020-11 2021-04 Issued Notice of Compliance
Denosumab Drugs for treatment of bone diseases 203717 2017-04 2018-02 Issued Notice of Compliance
Denosumab Drugs for treatment of bone diseases 205235 2017-06 2018-04 Issued Notice of Compliance
Dexlansoprazole Drugs for acid related disorders 215955 2018-06 2019-04 Issued Notice of Compliance
Dimethyl fumarate Other nervous system drugs 213790 2018-04 2019-02 Issued Notice of Compliance
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), inactivated poliomyelitis vaccine (D.C.O) Type 1 Mahoney, inactivated poliomyelitis vaccine (D.C.O) Type 2 M.E.F.1, inactivated poliomyelitis vaccine (D.C.O) Type 3 Saukett, pertactin, pertussis toxoid, tetanus toxoid Vaccines 220233 2018-11 2020-09 Issued Notice of Compliance
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid Vaccines 220103 2018-11 2020-09 Issued Notice of Compliance
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, inactivated poliovirus type I, inactivated poliovirus type II, inactivated poliovirus type III, pertactin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed Vaccines 243463 2020-10 2021-08 Issued Notice of Compliance
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed Vaccines 243456 2020-10 2021-08 Issued Notice of Compliance
Dolutegravir Antivirals for systemic use 207076 2017-08 2018-05 Issued Notice of Compliance
Dolutegravir Antivirals for systemic use 235583 2020-04 2021-01 Issued Notice of Compliance
Dulaglutide Drugs used in diabetes 201964 2017-03 2017-12 Issued Notice of Compliance
Dulaglutide Drugs used in diabetes 232128 2019-11 2020-09 Issued Notice of Compliance
Dupilumab Other dermatological preparations 221043 2018-11 2019-09 Issued Notice of Compliance
Dupilumab Other dermatological preparations 231268 2019-10 2020-08 Issued Notice of Compliance
Dupilumab Other dermatological preparations 234105 2020-01 2020-11 Issued Notice of Compliance
Dupilumab Other dermatological preparations 237081 2020-04 2021-02 Issued Notice of Compliance
Durvalumab Antineoplastic agents 233107 2019-11 2020-09 Issued Notice of Compliance
Eculizumab Immunosuppressants 212987 2018-02 2018-08 Issued Notice of Compliance
Eculizumab Immunosuppressants 225847 2019-04 2019-09 Issued Notice of Compliance
Eltrombopag olamine Antihemorrhagics 195798 2016-07 2017-05 Issued Notice of Compliance
Eltrombopag olamine Antihemorrhagics 217802 2018-07 2019-05 Issued Notice of Compliance
Eltrombopag olamine Antihemorrhagics 216004 2018-06 2019-06 Cancelled by sponsor
Emicizumab Antihemorrhagics 222209 2018-12 2019-06 Issued Notice of Compliance
Empagliflozin Drugs used in diabetes 193840 2016-05 2018-04 Issued Notice of Compliance
Empagliflozin Drugs used in diabetes 221628 2019-01 2019-04 Issued Notice of Compliance
Empagliflozin, linagliptin Drugs used in diabetes 204589 2017-06 2018-04 Issued Notice of Compliance
Emtricitabine, tenofovir alafenamide Antivirals for systemic use 234525 2020-02 2020-11 Issued Notice of Compliance
Enoxaparin sodium Antithrombotic agents 209807 2017-11 2018-09 Issued Notice of Compliance
Enzalutamide Endocrine therapy 216719 2018-06 2018-12 Issued Notice of Compliance
Enzalutamide Endocrine therapy 233563 2019-12 2020-06 Issued Notice of Compliance
Eptacog alfa Antihemorrhagics 200866 2017-01 2017-11 Issued Notice of Compliance
Eribulin mesylate Antineoplastic agents 197739 2016-10 2017-08 Issued Notice of Compliance
Erlotinib hydrochloride Antineoplastic agents 194018 2016-06 2017-03 Issued Notice of Compliance
Esketamine hydrochloride Psychoanaleptics 244338 2020-11 2021-09 Issued Notice of Compliance
Eslicarbazepine acetate Antiepileptics 208086 2017-09 2018-06 Issued Notice of Compliance
Eslicarbazepine acetate Antiepileptics 209753 2017-11 2018-09 Issued Notice of Compliance
Etanercept Immunosuppressants 193787 2016-05 2017-03 Issued Notice of Compliance
Etanercept Immunosuppressants 213347 2018-03 2019-01 Issued Notice of Compliance
Etanercept Immunosuppressants 231313 2019-10 2020-08 Issued Notice of Compliance
Etanercept Immunosuppressants 226145 2019-05 2020-12 Issued Notice of Compliance
Everolimus Antineoplastic agents 200814 2017-01 2017-11 Issued Notice of Compliance
Evolocumab Lipid modifying agents 207038 2017-08 2018-06 Issued Notice of Compliance
Evolocumab Lipid modifying agents 208904 2017-10 2018-08 Issued Notice of Compliance
Exenatide Drugs used in diabetes 208034 2017-09 2018-07 Issued Notice of Compliance
Fibrinogen (human) Antihemorrhagics 230407 2019-09 2020-07 Issued Notice of Compliance
Fibrinogen (human) Antihemorrhagics 227551 2019-06 2020-11 Cancelled by sponsor
Fingolimod hydrochloride Immunosuppressants 215423 2018-05 2018-11 Issued Notice of Compliance
Flibanserin Other gynecologicals 229727 2019-07 2021-01 Issued Notice of Compliance
Fluticasone furoate Drugs for obstructive airway diseases 208727 2017-10 2018-10 Cancelled by sponsor
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 215148 2018-05 2019-03 Issued Notice of Compliance
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 240101 2020-07 2021-05 Issued Notice of Compliance
Formoterol fumarate dihydrate, mometasone furoate Drugs for obstructive airway diseases 239493 2020-06 2021-04 Issued Notice of Compliance
Fulvestrant Endocrine therapy 201150 2017-01 2017-11 Issued Notice of Compliance
Gadoterate meglumine Contrast media 205610 2017-06 2018-04 Issued Notice of Compliance
Galcanezumab Analgesics 232324 2019-11 2020-09 Issued Notice of Compliance
Glecaprevir, pibrentasvir Antivirals for systemic use 222816 2018-12 2019-06 Issued Notice of Compliance
Glycopyrronium bromide, indacaterol maleate Drugs for obstructive airway diseases 198552 2016-11 2017-08 Issued Notice of Compliance
Golimumab Immunosuppressants 197362 2016-09 2017-06 Issued Notice of Compliance
Golimumab Immunosuppressants 205724 2017-06 2018-04 Issued Notice of Compliance
Guselkumab Immunosuppressants 232124 2019-11 2020-09 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines 199807 2016-11 2017-05 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 225528 2019-04 2020-02 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) Vaccines 218188 2018-08 2019-06 Cancelled by sponsor
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 229325 2019-08 2020-06 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 238479 2020-05 2021-03 Issued Notice of Compliance
Human immunoglobulin Immune sera and immunoglobulins 208033 2017-09 2018-07 Issued Notice of Compliance
Hydromorphone hydrochloride Analgesics 223245 2019-01 2019-05 Issued Notice of Compliance
Hydroxyethyl starch Blood substitutes and perfusion solutions 222938 2019-04 2020-02 Issued Notice of Compliance
Hydroxyethyl starch Blood substitutes and perfusion solutions 223031 2019-04 2020-02 Issued Notice of Compliance
Hydroxyurea Antineoplastic agents 226144 2019-04 2020-02 Issued Notice of Compliance
Ibrutinib Immunosuppressants 204436 2017-05 2017-10 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 212632 2018-02 2018-07 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 218457 2018-08 2019-02 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 222804 2019-01 2019-11 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 235706 2020-02 2020-12 Issued Notice of Compliance
Icatibant acetate Other hematological agents 217805 2018-09 2019-06 Issued Notice of Compliance
Idelalisib Antineoplastic agents 203513 2017-04 2017-12 Cancelled by sponsor
Immunoglobulin (human) Immune sera and immunoglobulins 201326 2017-01 2017-10 Issued Notice of Compliance
Immunoglobulin (human) Immune sera and immunoglobulins 223557 2019-02 2019-11 Cancelled by sponsor
Immunoglobulin (human) Immune sera and immunoglobulins 240691 2020-07 2021-05 Issued Notice of Compliance
IncobotulinumtoxinA Muscle relaxants 208713 2017-10 2019-06 Issued Notice of Compliance
IncobotulinumtoxinA Muscle relaxants 234438 2020-01 2020-11 Issued Notice of Compliance
Infliximab Immunosuppressants 220321 2018-11 2019-08 Issued Notice of Compliance
Insulin aspart Drugs used in diabetes 226586 2019-05 2020-02 Issued Notice of Compliance
Insulin degludec Drugs used in diabetes 208917 2017-10 2018-07 Issued Notice of Compliance
Insulin degludec, liraglutide Drugs used in diabetes 234406 2020-01 2020-11 Issued Notice of Compliance
Insulin glargine Drugs used in diabetes 228382 2019-07 2020-05 Issued Notice of Compliance
Insulin glargine, lixisenatide Drugs used in diabetes 232504 2019-11 2020-09 Issued Notice of Compliance
Ipilimumab Antineoplastic agents 202533 2017-02 2017-04 Issued Notice of Compliance
Isatuximab Antineoplastic agents 244601 2020-10 2021-09 Issued Notice of Compliance
Ivacaftor Other respiratory system products 218044 2018-08 2019-01 Issued Notice of Compliance
Ivacaftor Other respiratory system products 247481 2021-02 2021-08 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products 198036 2016-10 2017-04 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products 215032 2018-06 2018-12 Issued Notice of Compliance
Ixekizumab Immunosuppressants 204690 2017-06 2018-03 Issued Notice of Compliance
Ixekizumab Immunosuppressants 225178 2019-04 2020-02 Issued Notice of Compliance
Ixekizumab Immunosuppressants 233071 2019-12 2020-10 Issued Notice of Compliance
Ixekizumab Immunosuppressants 238580 2020-06 2021-03 Issued Notice of Compliance
Japanese encephalitis virus vaccine inactivated Vaccines 203520 2017-05 2018-03 Issued Notice of Compliance
Lacosamide Antiepileptics 193732 2016-05 2017-02 Issued Notice of Compliance
Lanreotide acetate Pituitary and hypothalamic hormones and analogues 203094 2017-04 2018-02 Issued Notice of Compliance
Ledipasvir, sofosbuvir Antivirals for systemic use 199607 2016-11 2017-05 Issued Notice of Compliance
Lenvatinib mesylate Antineoplastic agents 197794 2016-11 2017-09 Issued Notice of Compliance
Lenvatinib mesylate Antineoplastic agents 212989 2018-02 2018-12 Issued Notice of Compliance
Lenvatinib mesylate Antineoplastic agents 228723 2019-07 2019-09 Issued Notice of Compliance under the NOC/c Guidance
Leuprolide acetate Endocrine therapy 193372 2016-05 2017-02 Issued Notice of Compliance
Levomilnacipran Psychoanaleptics 222857 2019-01 2019-11 Issued Notice of Compliance
Levonorgestrel Sex hormones and modulators of the genital system 204355 2017-05 2018-03 Issued Notice of Compliance
Linagliptin Drugs used in diabetes 194075 2016-06 2018-10 Issued Notice of Compliance
Linagliptin Drugs used in diabetes 222572 2019-01 2019-11 Issued Notice of Compliance
Linagliptin, metformin hydrochloride Drugs used in diabetes 194067 2016-06 2017-05 Cancelled by sponsor
Linagliptin, metformin hydrochloride Drugs used in diabetes 229225 2019-08 2020-06 Issued Notice of Compliance
Liraglutide Drugs used in diabetes 196457 2016-08 2017-06 Issued Notice of Compliance
Liraglutide Drugs used in diabetes 200821 2017-01 2017-11 Issued Notice of Compliance
Liraglutide Drugs used in diabetes 225809 2019-05 2020-02 Issued Notice of Compliance
Liraglutide Drugs used in diabetes 237880 2020-05 2021-02 Issued Notice of Compliance
Lorlatinib Antineoplastic agents 247174 2021-01 2021-06 Issued Notice of Compliance
Lurasidone hydrochloride Psycholeptics 197342 2016-09 2017-07 Issued Notice of Compliance
Lurasidone hydrochloride Psycholeptics 205325 2017-06 2018-04 Issued Notice of Compliance
Macitentan Antihypertensives 219599 2018-11 2019-11 Cancelled by sponsor
Macitentan Antihypertensives 221389 2019-01 2020-07 Issued Notice of Compliance
Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid Vaccines 203844 2017-04 2018-02 Issued Notice of Compliance
Mepolizumab Drugs for obstructive airway diseases 208467 2017-09 2018-07 Issued Notice of Compliance
Mepolizumab Drugs for obstructive airway diseases 212242 2018-02 2018-10 Cancelled by sponsor
Mepolizumab Drugs for obstructive airway diseases 221528 2018-12 2019-10 Issued Notice of Compliance
Mepolizumab Drugs for obstructive airway diseases 226197 2019-05 2020-03 Issued Notice of Compliance
Methylphenidate hydrochloride Psychoanaleptics 214860 2018-05 2019-03 Issued Notice of Compliance
Methylphenidate hydrochloride Psychoanaleptics 224342 2019-03 2020-01 Issued Notice of Compliance
Midostaurin Antineoplastic agents 210496 2017-12 2018-10 Issued Notice of Compliance
Mifepristone, misoprostol Sex hormones and modulators of the genital system 200856 2017-01 2017-11 Issued Notice of Compliance
Nadroparin calcium Antithrombotic agents 195973 2016-08 2017-07 Issued Notice of Compliance
Naloxegol oxalate Drugs for constipation 221031 2018-11 2019-09 Cancelled by sponsor
Neratinib maleate Antineoplastic agents 242449 2020-09 2021-06 Issued Notice of Compliance
Nilotinib Antineoplastic agents 211052 2017-12 2018-10 Issued Notice of Compliance
Nintedanib Antineoplastic agents 227166 2019-05 2019-11 Issued Notice of Compliance
Nintedanib Antineoplastic agents 232923 2019-11 2020-05 Issued Notice of Compliance
Nintedanib Antineoplastic agents 241747 2020-08 2021-06 Issued Notice of Compliance
Niraparib Antineoplastic agents 237670 2020-04 2020-10 Issued Notice of Compliance
Nivolumab Antineoplastic agents 199379 2016-11 2017-05 Issued Notice of Compliance
Nivolumab Antineoplastic agents 203286 2017-03 2017-11 Issued Notice of Compliance
Nivolumab Antineoplastic agents 203593 2017-04 2018-01 Cancelled by sponsor
Nivolumab Antineoplastic agents 206974 2017-07 2018-03 Issued Notice of Compliance under the NOC/c Guidance
Nivolumab Antineoplastic agents 212067 2018-01 2018-07 Issued Notice of Compliance
Nivolumab Antineoplastic agents 211838 2018-01 2018-11 Issued Notice of Compliance
Nivolumab Antineoplastic agents 215535 2018-06 2019-11 Cancelled by sponsor
Nivolumab Antineoplastic agents 236255 2020-03 2020-08 Issued Notice of Compliance
Nivolumab Antineoplastic agents 234228 2020-01 2020-11 Issued Notice of Compliance
Nivolumab Antineoplastic agents 239474 2020-06 2021-02 Issued Notice of Compliance under the NOC/c Guidance
Nivolumab Antineoplastic agents 243600 2020-09 2021-05 Issued Notice of Compliance
Nivolumab Antineoplastic agents 247045 2021-01 2021-07 Issued Notice of Compliance
Norfloxacin Antibacterials for systemic use 208906 2017-10 2017-12 Issued Notice of Compliance
Obinutuzumab Antineoplastic agents 208089 2017-09 2018-07 Issued Notice of Compliance
Olaparib Antineoplastic agents 210204 2017-11 2018-05 Issued Notice of Compliance
Olaparib Antineoplastic agents 219799 2018-11 2019-05 Issued Notice of Compliance
Olaparib Antineoplastic agents 230309 2019-08 2020-02 Issued Notice of Compliance
Olaparib Antineoplastic agents 235698 2020-02 2020-08 Issued Notice of Compliance
Olodaterol hydrochloride, tiotropium bromide monohydrate Drugs for obstructive airway diseases 223910 2019-03 2019-12 Issued Notice of Compliance
Omalizumab Drugs for obstructive airway diseases 194542 2016-06 2017-04 Issued Notice of Compliance
Omalizumab Drugs for obstructive airway diseases 241064 2020-08 2021-07 Issued Notice of Compliance
Ombitasvir, paritaprevir, ritonavir Antivirals for systemic use 195504 2016-07 2017-05 Issued Notice of Compliance
OnabotulinumtoxinA Muscle relaxants 211053 2017-12 2018-10 Issued Notice of Compliance
OnabotulinumtoxinA Muscle relaxants 237685 2020-05 2021-03 Issued Notice of Compliance
Osimertinib mesylate Antineoplastic agents 211762 2018-01 2018-07 Issued Notice of Compliance
Osimertinib mesylate Antineoplastic agents 243288 2020-09 2021-01 Issued Notice of Compliance
Outer membrane vesicles (Neisseria meningitidis group B NZ98/254 strain), recombinant Neisseria meningitidis group B NHBA fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B fHBP fusion protein Vaccines 209413 2017-11 2018-08 Issued Notice of Compliance
Palbociclib Antineoplastic agents 195948 2016-07 2017-05 Issued Notice of Compliance
Palbociclib Antineoplastic agents 219500 2018-10 2019-08 Issued Notice of Compliance
Palonosetron hydrochloride Antiemetics and antinauseants 215829 2018-06 2019-04 Issued Notice of Compliance
Panitumumab Antineoplastic agents 193962 2016-06 2017-04 Issued Notice of Compliance
Pasireotide Pituitary and hypothalamic hormones and analogues 209345 2017-11 2018-08 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 201200 2017-01 2017-09 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 203157 2017-03 2017-09 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 212388 2018-01 2018-09 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 215699 2018-05 2019-03 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 209011 2017-09 2019-04 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 216451 2018-06 2019-04 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 218779 2018-08 2019-04 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 219700 2018-10 2019-07 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 228721 2019-07 2019-09 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 223819 2019-02 2019-12 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 219213 2018-09 2020-03 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 232775 2019-12 2020-10 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 236910 2020-04 2020-12 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 240864 2020-07 2021-03 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 246922 2020-12 2021-06 Issued Notice of Compliance
Perampanel Antiepileptics 204327 2017-05 2018-03 Issued Notice of Compliance
Perampanel Antiepileptics 225719 2019-05 2020-02 Issued Notice of Compliance
Pertuzumab Antineoplastic agents 209467 2017-11 2018-08 Issued Notice of Compliance
Pertuzumab, trastuzumab Antineoplastic agents 222022 2018-12 2020-07 Issued Notice of Compliance
Pertuzumab, trastuzumab Antineoplastic agents 230602 2019-09 2021-02 Issued Notice of Compliance
Pimecrolimus Other dermatological preparations 220947 2018-11 2019-09 Issued Notice of Compliance
Plerixafor Immunostimulants 213345 2018-03 2019-01 Issued Notice of Compliance
Pomalidomide Immunosuppressants 218459 2018-09 2019-07 Issued Notice of Compliance
Ranibizumab Ophthalmologicals 201272 2017-01 2017-11 Issued Notice of Compliance
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein Vaccines 223244 2019-02 2020-08 Issued Notice of Compliance
Regorafenib Antineoplastic agents 203322 2017-04 2017-09 Issued Notice of Compliance
Regorafenib Antineoplastic agents 214314 2018-04 2019-02 Issued Notice of Compliance
Ribociclib succinate Antineoplastic agents 225074 2019-04 2020-02 Issued Notice of Compliance
Ribociclib succinate Antineoplastic agents 233623 2019-12 2020-10 Issued Notice of Compliance
Rifaximin Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 209230 2018-02 2018-12 Issued Notice of Compliance
Rituximab Antineoplastic agents 204718 2017-05 2018-03 Issued Notice of Compliance
Rituximab Antineoplastic agents 228130 2019-07 2020-05 Issued Notice of Compliance
Rituximab Antineoplastic agents 242572 2020-09 2021-06 Issued Notice of Compliance
Rivaroxaban Antithrombotic agents 211611 2018-01 2018-09 Issued Notice of Compliance
Rivaroxaban Antithrombotic agents 233166 2020-02 2020-11 Issued Notice of Compliance
Rivaroxaban Antithrombotic agents 234756 2020-03 2021-01 Issued Notice of Compliance
Romiplostim Antihemorrhagics 243699 2020-10 2021-08 Issued Notice of Compliance
Rufinamide Antiepileptics 194343 2016-06 2017-04 Issued Notice of Compliance
Sarilumab Immunosuppressants 211993 2018-01 2019-08 Issued Notice of Compliance
Secukinumab Immunosuppressants 219231 2018-09 2019-07 Issued Notice of Compliance
Secukinumab Immunosuppressants 235994 2020-03 2021-01 Issued Notice of Compliance
Secukinumab Immunosuppressants 240496 2020-07 2021-05 Issued Notice of Compliance
Semaglutide Drugs used in diabetes 227387 2019-06 2020-03 Cancelled by sponsor
Semaglutide Drugs used in diabetes 231580 2019-10 2020-08 Issued Notice of Compliance
Sevelamer carbonate All other therapeutic products 211598 2018-04 2019-02 Issued Notice of Compliance
Simeprevir Antivirals for systemic use 197253 2016-09 2017-07 Issued Notice of Compliance
Sofosbuvir, velpatasvir Antivirals for systemic use 199753 2016-12 2017-09 Issued Notice of Compliance
Sofosbuvir, velpatasvir Antivirals for systemic use 233923 2020-01 2020-11 Issued Notice of Compliance
Somatropin Pituitary and hypothalamic hormones and analogues 205985 2017-06 2018-04 Issued Notice of Compliance
Somatropin Pituitary and hypothalamic hormones and analogues 241147 2020-08 2021-06 Issued Notice of Compliance
Somatropin R-DNA origin Pituitary and hypothalamic hormones and analogues 229726 2019-08 2020-06 Issued Notice of Compliance
Standardized short ragweed pollen allergenic extract Allergens 234565 2020-02 2020-12 Issued Notice of Compliance
Sulfur hexafluoride Contrast media 231944 2019-11 2020-08 Issued Notice of Compliance
Sunitinib malate Antineoplastic agents 208710 2017-10 2019-04 Issued Notice of Non-compliance- Withdrawal
Teduglutide Other alimentary tract and metabolism products 223862 2019-02 2019-08 Issued Notice of Compliance
Teriflunomide Immunosuppressants 221225 2018-12 2019-09 Issued Notice of Compliance
Teriflunomide Immunosuppressants 231739 2019-11 2020-09 Issued Notice of Compliance
Thioguanine Antineoplastic agents 199259 2016-11 2017-09 Issued Notice of Compliance
Ticagrelor Antithrombotic agents 231818 2019-10 2020-08 Issued Notice of Compliance
Tinzaparin sodium Antithrombotic agents 199839 2016-12 2018-11 Cancelled by sponsor
Tipiracil hydrochloride, trifluridine Antineoplastic agents 227070 2019-05 2019-11 Issued Notice of Compliance
Tocilizumab Immunosuppressants 204251 2017-05 2017-10 Issued Notice of Compliance
Tocilizumab Immunosuppressants 219690 2018-10 2019-07 Issued Notice of Compliance
Tocilizumab Immunosuppressants 220039 2018-10 2019-08 Issued Notice of Compliance
Tofacitinib Immunosuppressants 209522 2017-11 2018-09 Issued Notice of Compliance
Tofacitinib Immunosuppressants 209643 2017-12 2018-10 Issued Notice of Compliance
Tofacitinib Immunosuppressants 213578 2018-04 2019-01 Issued Notice of Compliance
Tolvaptan Diuretics 213262 2018-03 2019-01 Issued Notice of Compliance
Trametinib Antineoplastic agents 199382 2016-11 2017-05 Issued Notice of Compliance
Trametinib Antineoplastic agents 210760 2017-11 2018-05 Issued Notice of Compliance
Trametinib Antineoplastic agents 213580 2018-03 2018-09 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 239083 2020-06 2021-04 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 237674 2020-05 2021-04 Issued Notice of Compliance
Trastuzumab Antineoplastic agents 242479 2020-09 2021-04 Issued Notice of Compliance
Trastuzumab emtansine Antineoplastic agents 227372 2019-05 2019-11 Issued Notice of Compliance
Tretinoin Anti-acne preparations 235656 2020-03 2021-01 Issued Notice of Compliance
Umeclidinium bromide Drugs for obstructive airway diseases 222505 2019-01 2020-09 Issued Notice of Compliance
Upadacitinib Immunosuppressants 241253 2020-08 2021-06 Issued Notice of Compliance
Ustekinumab Immunosuppressants 224739 2019-03 2020-01 Issued Notice of Compliance
Ustekinumab Immunosuppressants 230279 2019-08 2020-06 Issued Notice of Compliance
Venetoclax Antineoplastic agents 214078 2018-03 2018-09 Issued Notice of Compliance
Venetoclax Antineoplastic agents 228475 2019-07 2020-04 Issued Notice of Compliance
Venetoclax Antineoplastic agents 240541 2020-06 2021-01 Issued Notice of Compliance
Vilazodone hydrochloride Psychoanaleptics 210066 2017-11 2018-10 Cancelled by sponsor
Vortioxetine hydrobromide Psychoanaleptics 212548 2018-02 2018-12 Issued Notice of Compliance
Footnote 1

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

Return to footnote a referrer

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: