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
Abatacept Immunosuppressants 255926 2021-09 2022-07 Issued Notice of Compliance
Abemaciclib Antineoplastic agents 249557 2021-03 2022-01 Issued Notice of Compliance
Abemaciclib Antineoplastic agents 270898 2023-03 2023-12 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
Ad26.COV2.S (recombinant) Vaccines 259715 2021-12 2022-05 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
Adalimumab Immunosuppressants 257327 2021-11 2022-08 Issued Notice of Compliance
Adalimumab Immunosuppressants 256159 2021-10 2022-09 Issued Notice of Compliance
Adalimumab Immunsuppressants 258125 2021-12 2022-10 Issued Notice of Compliance
Adalimumab Immunsuppressants 259979 2022-02 2022-11 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
Anakinra Immunosuppressants 237738 2020-05 2021-10 Cancelled by sponsor
Anidulafungin Antimycotics for systemic use 262044 2022-07 2023-05 Issued Notice of Compliance
Anthrax antigen filtrate Vaccines 234257 2020-01 2020-11 Issued Notice of Compliance
Antihemophilic factor (recombinant) Antihemorrhagics 250002 2021-03 2022-01 Issued Notice of Compliance
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 211971 2018-01 2018-11 Issued Notice of Compliance
Antihemophilic factor (recombinant), pegylated Antihemorrhagics 245031 2020-11 2021-11 Issued Notice of Compliance
Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated Antihemorrhagics 268221 2022-11 2023-09 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
Atezolizumab Antineoplastic agents 254361 2021-07 2022-01 Issued Notice of Compliance
Atezolizumab Antineoplastic agents 254159 2021-08 2022-03 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
Axicabtagene ciloleucel Antineoplastic agents 256106 2021-10 2022-09 Issued Notice of Compliance under the NOC/c Guidance
Axicabtagene ciloleucel Antineoplastic agents 259651 2022-02 2022-12 Issued Notice of Compliance
Axitinib Antineoplastic agents 245813 2020-12 2021-10 Issued Notice of Compliance
Azelastine hydrochloride, fluticasone propionate Nasal preparations 221498 2018-12 2019-10 Issued Notice of Compliance
Azelastine hydrochloride, fluticasone propionate Nasal preparations 254371 2021-08 2022-05 Issued Notice of Compliance
Baricitinib Immunosuppressants 245874 2020-12 2022-01 Cancelled by sponsor
Baricitinib Immunosuppressants 256724 2021-10 2023-06 Issued Notice of Non-compliance- Withdrawal
Baricitinib Immunosuppressants 270684 2023-04 2024-01 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
Belzutifan Antineoplastic agents 270609 2023-01 2023-07 Issued Notice of Compliance
Betamethasone dipropionate, calcipotriol monohydrate Corticosteroids, dermatological preparations 247673 2021-01 2021-10 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
Bevacizumab Antineoplastic agents 257734 2021-12 2022-10 Issued Notice of Compliance
Bevacizumab Antineoplastic agents 259936 2022-02 2022-11 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
Bimekizumab Immunosuppressants 273184 2023-05 2024-02 Issued Notice of Compliance
Bisoprolol fumarate Beta blocking agents 243497 2021-01 2024-01 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
Brentuximab vedotin Antineoplastic agents 268334 2022-12 2023-09 Cancelled by sponsor
Brexpiprazole Psycholeptics 205854 2017-07 2019-02 Issued Notice of Compliance
Brexpiprazole Psycholeptics 257995 2021-12 2022-06 Cancelled by sponsor
Brexpiprazole Psycholeptics 272694 2023-04 2024-01 Issued Notice of Compliance
Brexucabtagene autoleucel Antineoplastic agents 262249 2022-04 2022-11 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
Brolucizumab Ophthalmologicals 259754 2022-02 2022-11 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
Cabotegravir, rilpivirine Antivirals for systemic use 254233 2021-08 2022-06 Issued Notice of Compliance
Cabotegravir, rilpivirine Antivirals for systemic use 258574 2022-02 2022-12 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
Cabozantinib Antineoplastic agents 245824 2020-12 2021-10 Issued Notice of Compliance
Cabozantinib malate Antineoplastic agents 257143 2021-11 2022-04 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
Carfilzomib Antineoplastic agents 267413 2022-10 2023-07 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
Cemiplimab Antineoplastic agents 246918 2020-12 2021-10 Issued Notice of Compliance
Cemiplimab Antineoplastic agents 256178 2021-09 2022-03 Issued Notice of Compliance
Cemiplimab Antineoplastic agents 263700 2022-05 2023-04 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
ChAdOx1-S (recombinant) Vaccines 259446 2021-12 2022-03 Cancelled by sponsor
Cilgavimab, tixagevimab Immune sera and immunoglobulins 265382 2022-06 2022-10 Issued Notice of Compliance
Coagulation factor VIII (human), human plasma proteins, von Willebrand factor (human) Antihemorrhagics 274244 2023-05 2024-02 Issued Notice of Compliance
Coagulation factor IX (recombinant), pegylated Antihemorrhagics 258126 2021-12 2022-10 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 polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F Vaccines 259725 2022-01 2022-07 Issued Notice of Compliance
Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F Vaccines 270922 2023-01 2023-07 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
Dabrafenib mesylate Antineoplastic agents 270381 2023-01 2023-07 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 propanediol monohydrate Drugs used in diabetes 268982 2022-12 2023-10 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
Daratumumab Antineoplastic agents 249815 2021-03 2022-01 Issued Notice of Compliance
Daratumumab Antineoplastic agents 259880 2022-02 2022-12 Issued Notice of Compliance
Darolutamide Endocrine therapy 262749 2022-04 2022-09 Issued Notice of Compliance
Davesomeran, elasomeran Vaccines 273747 2023-03 2023-05 Issued Notice of Compliance
Davesomeran, elasomeran Vaccines 274717 2023-05 2023-10 Cancelled by sponsor
Doravirine, lamivudine, tenofovir disoproxil fumarate Antivirals for systemic use 266249 2022-09 2023-07 Issued Notice of Compliance
Dostarlimab Antineoplastic agents 274515 2023-05 2023-11 Issued Notice of Compliance
Deferiprone All other therapeutic products 244597 2020-12 2021-10 Issued Notice of Compliance
Deferiprone All other therapeutic products 261912 2022-06 2023-03 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
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 241617 2020-09 2022-12 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
Dimethyl fumarate Immunosuppressants 259869 2022-04 2023-05 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
Doravirine Antivirals for systemic use 264733 2022-07 2023-05 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
Dupilumab Other dermatological preparations 252306 2021-05 2022-03 Issued Notice of Compliance
Dupilumab Other dermatological preparations 264439 2022-06 2023-04 Issued Notice of Compliance
Dupilumab Other dermatological preparations 268311 2022-11 2023-05 Issued Notice of Compliance
Dupilumab Other dermatological preparations 266537 2022-09 2023-07 Issued Notice of Compliance
Durvalumab Antineoplastic agents 233107 2019-11 2020-09 Issued Notice of Compliance
Durvalumab Antineoplastic agents 262782 2022-04 2022-09 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
Elasomeran Vaccines 257293 2021-10 2021-11 Issued Notice of Compliance
Elasomeran Vaccines 258658 2021-11 2022-03 Issued Notice of Compliance
Elasomeran Vaccines 263775 2022-04 2022-07 Issued Notice of Compliance
Elasomeran Vaccines 262952 2022-04 2022-09 Cancelled by sponsor
Elasomeran Vaccines 262408 2022-03 2022-12 Issued Notice of Compliance
Elasomeran, imelasomeran Vaccines 269428 2022-11 2023-02 Issued Notice of Compliance
Elexacaftor, ivacaftor, tezacaftor Other respiratory system products 255136 2021-10 2022-04 Issued Notice of Compliance
Elexacaftor, ivacaftor, tezacaftor Other respiratory system products 271750 2023-04 2023-10 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 Drugs used in diabetes 246457 2021-01 2021-10 Issued Notice of Compliance
Empagliflozin Drugs used in diabetes 256491 2021-10 2022-04 Issued Notice of Compliance
Empagliflozin Drugs used in diabetes 270652 2023-03 2024-01 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
Enzalutamide Endocrine therapy 277282 2023-08 2024-01 Issued Notice of Compliance
Eptacog alfa Antihemorrhagics 200866 2017-01 2017-11 Issued Notice of Compliance
Eptacog alfa Antihemorrhagics 267878 2022-11 2023-03 Cancelled by sponsor
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
Evolocumab Lipid modifying agents 247936 2021-02 2021-12 Issued Notice of Compliance
Exenatide Drugs used in diabetes 208034 2017-09 2018-07 Issued Notice of Compliance
Famtozinameran, tozinameran Vaccines 268826 2022-10 2022-12 Issued Notice of Compliance
Famtozinameran, tozinameran Vaccines 274152 2023-03 2023-07 Issued Notice of Compliance
Famtozinameran, tozinameran Vaccines 275559 2023-06 2023-08 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
Fosfomycin sodium Antibacterials for systemic use 256308 2021-12 2022-10 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
Gadoteridol Contrast media 252254 2021-07 2022-05 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
Glecaprevir, pibrentasvir Antivirals for systemic use 247707 2021-02 2021-11 Issued Notice of Compliance
Glycerol phenylbutyrate Other alimentary tract and metabolism products 259175 2022-02 2022-11 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
Golimumab Immunosuppressants 255908 2021-10 2022-07 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(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
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 246936 2021-01 2021-11 Issued Notice of Compliance
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 251147 2021-05 2022-03 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
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
Ibrutinib Antineoplastic agents 263702 2022-05 2023-03 Issued Notice of Compliance
Ibrutinib Antineoplastic agents 266710 2022-10 2023-08 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
Immunoglobulin (human) Immune sera and immunoglobulins 253256 2021-07 2022-05 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
IncobotulinumtoxinA Muscle relaxants 251521 2021-05 2022-03 Issued Notice of Compliance
IncobotulinumtoxinA Muscle relaxants 257192 2021-11 2022-09 Issued Notice of Compliance
IncobotulinumtoxinA Muscle relaxants 268590 2022-11 2023-10 Cancelled by sponsor
Infliximab Immunosuppressants 220321 2018-11 2019-08 Issued Notice of Compliance
Infliximab Immunosuppressants 262141 2022-04 2023-03 Issued Notice of Compliance
Infliximab Immunosuppressants 272981 2023-04 2024-02 Issued Notice of Compliance
Insulin aspart Drugs used in diabetes 226586 2019-05 2020-02 Issued Notice of Compliance
Insulin aspart Drugs used in diabetes 254352 2021-10 2022-07 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
Iohexol Contrast media 268527 2023-03 2023-12 Issued Notice of Compliance
Ipilimumab Antineoplastic agents 202533 2017-02 2017-04 Issued Notice of Compliance
Ipilimumab Antineoplastic agents 255450 2021-09 2022-03 Issued Notice of Compliance
Ipilimumab Antineoplastic agents 270801 2023-02 2023-12 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 Other respiratory system products 255781 2021-09 2022-03 Issued Notice of Compliance
Ivacaftor Other respiratory system products 273575 2023-06 2023-11 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
Ivacaftor, lumacaftor Other respiratory system products 264825 2022-07 2023-04 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
Lenvatinib mesylate Antineoplastic agents 252195 2021-06 2022-02 Cancelled by sponsor
Lenvatinib mesylate Antineoplastic agents 253057 2021-07 2022-05 Issued Notice of Compliance
Letermovir Antivirals for systemic use 272553 2023-03 2023-09 Issued Notice of Compliance
Leucovorin calcium All other therapeutic products 276242 2023-08 2023-12 Issued Notice of Compliance
Leuprolide acetate Endocrine therapy 193372 2016-05 2017-02 Issued Notice of Compliance
Leuprolide acetate Endocrine therapy 269016 2022-12 2023-09 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
Levonorgestrel Other gynecologicals 273103 2023-04 2024-02 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
Lumasiran sodium Other alimentary tract and metabolism products 265088 2022-07 2023-05 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
Mavacamten Cardiac therapy 272517 2023-04 2024-02 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
Mepolizumab Drugs for obstructive airway diseases 247542 2021-01 2021-11 Issued Notice of Compliance
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 255153 2021-09 2022-08 Issued Notice of Compliance
Methyl aminolevulinate hydrochloride Antineoplastic agents 262828 2022-04 2023-02 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
Migalastat hydrochloride Other alimentary tract and metabolism products 262810 2022-05 2023-03 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
Nivolumab Antineoplastic agents 245851 2020-12 2021-10 Issued Notice of Compliance
Nivolumab Antineoplastic agents 247339 2021-01 2021-10 Issued Notice of Compliance
Nivolumab Antineoplastic agents 253652 2021-07 2022-06 Issued Notice of Compliance under the NOC/c Guidance
Nivolumab Antineoplastic agents 257103 2021-11 2022-07 Issued Notice of Compliance
Nivolumab Antineoplastic agents 261300 2022-03 2022-08 Issued Notice of Compliance
Nivolumab Antineoplastic agents 272504 2023-03 2023-12 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
Olaparib Antineoplastic agents 259417 2022-01 2022-07 Issued Notice of Compliance under the NOC/c Guidance
Olaparib Antineoplastic agents 265427 2022-08 2023-07 Issued Notice of Compliance under the NOC/c Guidance
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
OnabotulinumtoxinA Muscle relaxants 273166 2023-04 2024-02 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
Ozanimod Immunosuppressants 248992 2021-05 2022-04 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 239505 2020-06 2021-02 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
Pembrolizumab Antineoplastic agents 246373 2020-12 2021-11 Issued Notice of Compliance under the NOC/c Guidance
Pembrolizumab Antineoplastic agents 252263 2021-06 2022-02 Cancelled by sponsor
Pembrolizumab Antineoplastic agents 256659 2021-10 2022-04 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 257236 2021-11 2022-04 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 253060 2021-07 2022-05 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 259703 2022-01 2022-07 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 256537 2021-10 2022-08 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 264318 2022-06 2023-04 Issued Notice of Compliance
Pembrolizumab Antineoplastic agents 272409 2023-03 2024-02 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
Pertuzumab, trastuzumab Antineoplastic agents 254251 2021-07 2022-01 Issued Notice of Compliance
Pimecrolimus Other dermatological preparations 220947 2018-11 2019-09 Issued Notice of Compliance
Pimecrolimus Other dermatological preparations 247851 2021-01 2023-09 Cancelled by sponsor
Pitolisant hydrochloride Other nervous system drugs 270856 2023-02 2024-01 Issued Notice of Compliance
Plerixafor Immunostimulants 213345 2018-03 2019-01 Issued Notice of Compliance
Polatuzumab vedotin Antineoplastic agents 259726 2022-01 2022-11 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
Ranibizumab Opthalmologicals 233361 2019-11 2021-11 Issued Notice of Compliance under the NOC/c Guidance
Ravulizumab Immunosuppressants 259173 2022-01 2022-11 Issued Notice of Compliance
Ravulizumab Immunosuppressants 261864 2022-03 2023-01 Issued Notice of Compliance
Ravulizumab Immunosuppressants 269852 2023-01 2023-10 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
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein Vaccines 251509 2021-05 2022-04 Issued Notice of Compliance under the NOC/c Guidance
Regorafenib Antineoplastic agents 203322 2017-04 2017-09 Issued Notice of Compliance
Remdesivir Antivirals for systemic use 250151 2021-04 2022-04 Issued Notice of Compliance
Remdesivir Antivirals for systemic use 266313 2022-08 2023-06 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
Ribociclib succinate Antineoplastic agents 262779 2022-04 2023-02 Issued Notice of Compliance
Rifaximin Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 209230 2018-02 2018-12 Issued Notice of Compliance
Risankizumab Immunosuppressants 251455 2021-05 2022-03 Issued Notice of Compliance
Risankizumab Immunosuppressants 258394 2021-12 2022-10 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
Romosozumab Drugs for treatment of bone diseases 262756 2022-05 2023-03 Cancelled by sponsor
Rufinamide Antiepileptics 194343 2016-06 2017-04 Issued Notice of Compliance
Ruxolitinib phosphate Antineoplastic agents 250022 2021-03 2022-05 Issued Notice of Compliance
Sacituzumab govitecan Antineoplastic agents 270849 2023-01 2023-07 Issued Notice of Compliance
Sarilumab Immunosuppressants 211993 2018-01 2019-08 Issued Notice of Compliance
SARS-CoV-2 recombinant spike protein Vaccines 266285 2022-07 2022-11 Issued Notice of Compliance
SARS-CoV-2 recombinant spike protein Vaccines 265342 2022-06 2022-12 Issued Notice of Compliance
SARS-CoV-2 recombinant spike protein Vaccines 273313 2023-03 2023-11 Cancelled by sponsor
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
Secukinumab Immunosuppressants 250272 2021-05 2022-03 Issued Notice of Compliance
Secukinumab Immunosuppressants 257230 2021-11 2022-09 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
Semaglutide Drugs used in diabetes 245932 2020-12 2021-10 Issued Notice of Compliance
Semaglutide Drugs used in diabetes 266244 2022-09 2023-06 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
Sugammadex All other therapeutic products 234372 2020-01 2021-10 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 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
Tisagenlecleucel Antineoplastic agents 263500 2022-05 2022-12 Issued Notice of Compliance under the NOC/c Guidance
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
Tocilizumab Immunosuppressants 261220 2022-02 2022-10 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
Tofacitinib citrate Immunosuppressants 264582 2022-07 2023-05 Issued Notice of Compliance
Tolvaptan Diuretics 213262 2018-03 2019-01 Issued Notice of Compliance
Tozinameran Vaccines 257162 2021-10 2021-11 Issued Notice of Compliance
Tozinameran Vaccines 257698 2021-10 2021-11 Issued Notice of Compliance
Tozinameran Vaccines 261729 2022-02 2022-06 Issued Notice of Compliance
Tozinameran Vaccines 264621 2022-05 2022-08 Issued Notice of Compliance
Tozinameran Vaccines 265483 2022-06 2022-09 Issued Notice of Compliance
Tralokinumab Other dermatological preparations 261661 2022-04 2023-02 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
Trametinib Antineoplastic agents 270386 2023-01 2023-07 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 Antineoplastic agents 247842 2021-02 2021-12 Issued Notice of Compliance
Trastuzumab deruxtecan Antineoplastic agents 259440 2022-01 2022-06 Issued Notice of Compliance
Trastuzumab deruxtecan Antineoplastic agents 265333 2022-07 2023-01 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
Upadacitinib Immunosuppressants 245530 2020-12 2021-10 Issued Notice of Compliance
Upadacitinib Immunosuppressants 247702 2021-02 2022-07 Issued Notice of Compliance
Upadacitinib Immunosuppressants 264612 2022-07 2023-05 Issued Notice of Compliance
Upadacitinib Immunosuppressants 257284 2021-12 2023-07 Issued Notice of Compliance
Upadacitinib Immunosuppressants 267554 2022-12 2023-10 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
Varicella-zoster virus glycoprotein E (GE) Vaccines 246933 2021-01 2021-11 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
Virus-like particles (VLP) of SARS-CoV-2 spike protein Vaccines 267448 2022-08 2023-03 Issued Notice of Compliance
Zanubrutinib Antineoplastic agents 254556 2021-09 2022-02 Issued Notice of Compliance
Zanubrutinib Antineoplastic agents 264963 2022-07 2023-05 Issued Notice of Compliance
Zanubrutinib Antineoplastic agents 273215 2023-04 2024-02 Issued Notice of Compliance
Footnote a

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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