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
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
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
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
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, 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
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
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
Ivacaftor Other respiratory system products 218044 2018-08 2019-01 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products 198036 2016-10 2017-04 Issued Notice of Compliance
Ivacaftor, lumacaftor Other respiratory system products 215032 2018-06 2018-12 Issued Notice of Compliance
Ixekizumab Immunosuppressants 204690 2017-06 2018-03 Issued Notice of Compliance
Ixekizumab Immunosuppressants 225178 2019-04 2020-02 Issued Notice of Compliance
Ixekizumab Immunosuppressants 233071 2019-12 2020-10 Issued Notice of Compliance
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
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
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
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: