Drug and Health Product Submissions Under Review (SUR): Supplemental submissions completed
This list is current as of: 2026-07-31.
An Excel version of the updated SUR List is available from the Overview page.
| Submission Control Number | Medicinal Ingredient(s) | Therapeutic Area | Submission 'class' (if applicable) |
Date submission was accepted into review | Outcome of submission (hyperlinked if applicable) | Date submission concluded |
|---|---|---|---|---|---|---|
| 208070 | Abacavir sulfate, dolutegravir sodium, lamivudine | Antivirals for systemic use | Not applicable |
2017-08-11 | Issued Notice of Compliance | 2017-10-11 |
| 204313 | Abatacept | Immunosuppressants | Not applicable |
2017-05-19 | Issued Notice of Compliance | 2018-03-15 |
| 255926 | Abatacept | Immunosuppressants | Reviewed under Project Orbis Type B |
2021-09-16 | Issued Notice of Compliance | 2022-07-21 |
| 249557 | Abemaciclib | Antineoplastic agents | Not applicable |
2021-03-24 | Issued Notice of Compliance | 2022-01-12 |
| 270898 | Abemaciclib | Antineoplastic agents | Not applicable |
2023-03-03 | Issued Notice of Compliance | 2023-12-06 |
| 207915 | Abiraterone acetate | Endocrine therapy | Being reviewed under the Priority Review Policy |
2017-08-22 | Issued Notice of Compliance | 2018-02-13 |
| 300215 | Abiraterone acetate, niraparib tosylate | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2026-06-30 | Issued Notice of Compliance | 2026-06-23 |
| 202245 | Abobotulinumtoxina | Muscle relaxants | Not applicable |
2017-03-10 | Issued Notice of Compliance | 2017-12-21 |
| 204299 | Abobotulinumtoxina | Muscle relaxants | Not applicable |
2017-05-15 | Issued Notice of Compliance | 2018-03-09 |
| 206921 | Abobotulinumtoxina | Muscle relaxants | Not applicable |
2017-08-10 | Issued Notice of Compliance | 2018-04-24 |
| 236999 | Abobotulinumtoxina | Muscle relaxants | Not applicable |
2020-04-27 | Issued Notice of Compliance | 2021-02-19 |
| 231228 | Acalabrutinib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2019-10-01 | Issued Notice of Compliance | 2019-11-28 |
| 289986 | Acalabrutinib maleate | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-10-08 | Issued Notice of Compliance | 2025-06-24 |
| 291668 | Acalabrutinib maleate | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-11-28 | Issued Notice of Compliance | 2025-09-11 |
| 259715 | Ad26.COV2.S (recombinant) *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-12-17 | Issued Notice of Compliance | 2022-05-12 |
| 197529 | Adalimumab | Immunosuppressants | Not applicable |
2016-09-19 | Issued Notice of Compliance | 2017-07-14 |
| 201423 | Adalimumab | Immunosuppressants | Not applicable |
2017-02-08 | Issued Notice of Compliance | 2017-12-05 |
| 212133 | Adalimumab | Immunosuppressants | Not applicable |
2018-02-05 | Issued Notice of Compliance | 2018-11-30 |
| 213550 | Adalimumab | Immunosuppressants | Not applicable |
2018-03-29 | Issued Notice of Compliance | 2019-01-23 |
| 219453 | Adalimumab | Immunosuppressants | Biosimilar |
2018-10-04 | Issued Notice of Compliance | 2020-11-04 |
| 234183 | Adalimumab | Immunosuppressants | Biosimilar |
2019-12-19 | Issued Notice of Compliance | 2020-11-04 |
| 234258 | Adalimumab | Immunosuppressants | Biosimilar |
2020-01-31 | Issued Notice of Compliance | 2020-11-26 |
| 239280 | Adalimumab | Immunosuppressants | Not applicable |
2020-06-25 | Issued Notice of Compliance | 2021-04-21 |
| 244618 | Adalimumab | Immunosuppressants | Biosimilar |
2020-11-19 | Issued Notice of Compliance | 2021-09-10 |
| 257327 | Adalimumab | Immunosuppressants | Biosimilar |
2021-11-22 | Issued Notice of Compliance | 2022-08-12 |
| 256159 | Adalimumab | Immunosuppressants | Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2021-10-19 | Issued Notice of Compliance | 2022-09-09 |
| 258125 | Adalimumab | Immunosuppressants | Biosimilar |
2021-12-13 | Issued Notice of Compliance | 2022-10-11 |
| 259979 | Adalimumab | Immunosuppressants | Biosimilar |
2022-02-18 | Issued Notice of Compliance | 2022-11-14 |
| 282461 | Adalimumab | Immunosuppressants | Biosimilar |
2024-03-13 | Issued Notice of Compliance | 2025-01-15 |
| 281626 | Adalimumab | Immunosuppressants | Biosimilar |
2024-09-23 | Issued Notice of Compliance | 2025-06-19 |
| 209785 | Afatinib dimaleate | Antineoplastic agents | Not applicable |
2017-12-19 | Issued Notice of Compliance | 2018-09-20 |
| 278211 | Aflibercept | Ophthalmologicals | Not applicable |
2023-09-26 | Issued Notice of Compliance under the NOC/c Guidance | 2025-05-02 |
| 210816 | Alectinib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2017-12-21 | Issued Notice of Compliance | 2018-06-11 |
| 282375 | Alectinib hydrochloride | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-01-04 | Issued Notice of Compliance | 2024-06-27 |
| 239220 | Alemtuzumab | Immunosuppressants | Not applicable |
2020-07-03 | Issued Notice of Compliance | 2021-04-28 |
| 219669 | Alirocumab | Lipid modifying agents | Not applicable |
2018-10-05 | Issued Notice of Compliance | 2019-07-31 |
| 205855 | Alpha 1-proteinase inhibitor (human) | Antihemorrhagics | Not applicable |
2017-06-08 | Issued Notice of Compliance | 2017-06-30 |
| 288056 | Amifampridine phosphate | Other nervous system drugs | Not applicable |
2024-08-14 | Issued Notice of Compliance | 2025-06-10 |
| 282121 | Amivantamab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2024-01-02 | Issued Notice of Compliance | 2024-06-28 |
| 283969 | Amivantamab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2024-03-19 | Issued Notice of Compliance | 2025-01-13 |
| 299558 | Amivantamab | Antineoplastic agents | Reviewed under Project Orbis Type C |
2025-08-25 | Issued Notice of Compliance | 2026-06-18 |
| 195649 | Anakinra | Immunosuppressants | Not applicable |
2016-07-25 | Issued Notice of Compliance | 2017-05-18 |
| 237738 | Anakinra | Immunosuppressants | Being reviewed under the Submissions Relying on Third-Party Data Guidance Part of an 'aligned review' with a health technology assessment organization |
2020-05-08 | Cancelled by sponsor | 2021-10-29 |
| 262044 | Anidulafungin | Antimycotics for systemic use | Not applicable |
2022-07-13 | Issued Notice of Compliance | 2023-05-08 |
| 234257 | Anthrax antigen filtrate | Vaccines | Extraordinary use submission |
2020-01-27 | Issued Notice of Compliance | 2020-11-19 |
| 250002 | Antihemophilic factor (recombinant) | Antihemorrhagics | Not applicable |
2021-03-29 | Issued Notice of Compliance | 2022-01-19 |
| 211971 | Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | Not applicable |
2018-01-25 | Issued Notice of Compliance | 2018-11-21 |
| 245031 | Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | Not applicable |
2020-11-30 | Issued Notice of Compliance | 2021-11-05 |
| 291800 | Antihemophilic factor (recombinant, B-domain deleted, pegylated) | Antihemorrhagics | Not applicable |
2024-12-23 | Issued Notice of Compliance | 2025-10-20 |
| 268221 | Antihemophilic factor VIII (recombinant, B-domain truncated), pegylated | Antihemorrhagics | Not applicable |
2022-11-17 | Issued Notice of Compliance | 2023-09-11 |
| 228077 | Apalutamide | Endocrine therapy | Being reviewed under the Priority Review Policy |
2019-06-17 | Issued Notice of Compliance | 2019-12-12 |
| 198842 | Apixaban | Antithrombotic agents | Not applicable |
2016-11-18 | Issued Notice of Compliance | 2018-10-17 |
| 233030 | Apremilast | Immunosuppressants | Not applicable |
2019-12-19 | Issued Notice of Compliance | 2020-08-10 |
| 200292 | Aripiprazole | Psycholeptics | Not applicable |
2017-01-06 | Issued Notice of Compliance | 2017-11-02 |
| 266917 | Aripiprazole | Psycholeptics | Part of an 'aligned review' with a health technology assessment organization |
2022-09-29 | Issued Notice of Compliance | 2025-01-17 |
| 290676 | Asciminib hydrochloride | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-10-15 | Issued Notice of Compliance | 2025-07-25 |
| 205038 | Atezolizumab | Antineoplastic agents | Not applicable |
2017-06-12 | Issued Notice of Compliance | 2018-04-06 |
| 217324 | Atezolizumab | Antineoplastic agents | Not applicable |
2018-07-30 | Issued Notice of Compliance | 2019-05-24 |
| 223753 | Atezolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2019-02-11 | Issued Notice of Compliance | 2019-08-08 |
| 223911 | Atezolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2019-02-22 | Issued Notice of Compliance under the NOC/c Guidance | 2019-09-19 |
| 226905 | Atezolizumab | Antineoplastic agents | Not applicable |
2019-06-07 | Issued Notice of Compliance | 2020-04-02 |
| 235450 | Atezolizumab | Antineoplastic agents | Reviewed under Project Orbis Type A |
2020-02-20 | Issued Notice of Compliance | 2020-08-10 |
| 237371 | Atezolizumab | Antineoplastic agents | Not applicable |
2020-05-08 | Issued Notice of Compliance | 2021-03-01 |
| 254361 | Atezolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2021-07-23 | Issued Notice of Compliance | 2022-01-14 |
| 254159 | Atezolizumab | Antineoplastic agents | Not applicable |
2021-08-10 | Issued Notice of Compliance | 2022-03-29 |
| 300483 | Atezolizumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2025-09-11 | Issued Notice of Compliance | 2026-07-31 |
| 273484 | Atogepant | Analgesics | Not applicable |
2023-07-07 | Issued Notice of Compliance | 2024-05-02 |
| 297240 | Avapritinib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-05-16 | Issued Notice of Compliance | 2026-04-20 |
| 225974 | Avelumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2019-04-05 | Issued Notice of Compliance under the NOC/c Guidance | 2019-11-06 |
| 226954 | Avelumab | Antineoplastic agents | Not applicable |
2019-06-07 | Cancelled by sponsor | 2020-06-30 |
| 240024 | Avelumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2020-06-15 | Issued Notice of Compliance | 2020-12-10 |
| 256106 | Axicabtagene ciloleucel | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2021-10-14 | Issued Notice of Compliance under the NOC/c Guidance | 2022-09-29 |
| 259651 | Axicabtagene ciloleucel | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2022-02-04 | Issued Notice of Compliance | 2022-12-06 |
| 245813 | Axitinib | Antineoplastic agents | Not applicable |
2020-12-09 | Issued Notice of Compliance | 2021-10-04 |
| 221498 | Azelastine hydrochloride, fluticasone propionate | Nasal preparations | Not applicable |
2018-12-14 | Issued Notice of Compliance | 2019-10-04 |
| 254371 | Azelastine hydrochloride, fluticasone propionate | Nasal preparations | Not applicable |
2021-08-20 | Issued Notice of Compliance | 2022-05-18 |
| 245874 | Baricitinib | Immunosuppressants | Not applicable |
2020-12-18 | Cancelled by sponsor | 2022-01-28 |
| 270684 | Baricitinib | Immunosuppressants | Not applicable |
2023-04-03 | Issued Notice of Compliance | 2024-01-26 |
| 256724 | Baricitinib *For use in relation to COVID-19 | Immunosuppressants | For use in relation to COVID-19 |
2021-10-15 | Issued Notice of Non-compliance - Withdrawal | 2023-06-13 |
| 210469 | Bazedoxifene acetate, conjugated estrogens | Sex hormones and modulators of the genital system | Not applicable |
2017-11-30 | Issued Notice of Compliance | 2018-09-14 |
| 243390 | Belimumab | Immunosuppressants | Not applicable |
2020-10-02 | Issued Notice of Compliance | 2021-07-29 |
| 279522 | Belimumab | Immunosuppressants | Not applicable |
2023-11-15 | Issued Notice of Compliance | 2025-12-23 |
| 270609 | Belzutifan | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-16 | Issued Notice of Compliance | 2023-07-11 |
| 282593 | Belzutifan | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-02-15 | Issued Notice of Compliance | 2024-12-17 |
| 284185 | Benralizumab | Drugs for obstructive airway diseases | Not applicable |
2024-04-12 | Issued Notice of Compliance | 2025-07-18 |
| 247673 | Betamethasone dipropionate, calcipotriol monohydrate | Corticosteroids, dermatological preparations | Not applicable |
2021-01-29 | Issued Notice of Compliance | 2021-10-25 |
| 207259 | Bevacizumab | Antineoplastic agents | Not applicable |
2017-08-10 | Issued Notice of Compliance | 2018-06-06 |
| 218844 | Bevacizumab | Antineoplastic agents | Biosimilar |
2018-09-12 | Issued Notice of Compliance | 2019-06-05 |
| 230254 | Bevacizumab | Antineoplastic agents | Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2019-09-19 | Issued Notice of Compliance | 2020-02-21 |
| 232977 | Bevacizumab | Antineoplastic agents | Biosimilar |
2019-11-20 | Issued Notice of Compliance | 2021-01-05 |
| 257734 | Bevacizumab | Antineoplastic agents | Biosimilar |
2021-12-13 | Issued Notice of Compliance | 2022-10-06 |
| 259936 | Bevacizumab | Antineoplastic agents | Biosimilar |
2022-02-01 | Issued Notice of Compliance | 2022-11-23 |
| 226658 | Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | Not applicable |
2019-05-08 | Issued Notice of Compliance | 2020-03-02 |
| 240953 | Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | Not applicable |
2020-07-29 | Issued Notice of Compliance | 2021-05-21 |
| 288709 | Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | Not applicable |
2024-08-14 | Issued Notice of Compliance | 2025-06-10 |
| 241318 | Bilastine | Antihistamines for systemic use | Not applicable |
2020-10-15 | Issued Notice of Compliance | 2021-08-11 |
| 290817 | Bilastine | Ophthalmologicals | Not applicable |
2024-12-05 | Issued Notice of Compliance | 2025-10-01 |
| 273184 | Bimekizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2023-05-01 | Issued Notice of Compliance | 2024-02-23 |
| 273663 | Bimekizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2023-05-16 | Issued Notice of Compliance | 2024-03-11 |
| 286289 | Bimekizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2024-06-17 | Issued Notice of Compliance | 2025-12-12 |
| 243497 | Bisoprolol fumarate | Beta blocking agents | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-01-11 | Issued Notice of Compliance | 2024-01-04 |
| 197615 | Blinatumomab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2016-09-16 | Issued Notice of Compliance under the NOC/c Guidance | 2017-04-28 |
| 204154 | Blinatumomab | Antineoplastic agents | Not applicable |
2017-05-09 | Issued Notice of Compliance | 2018-03-05 |
| 210780 | Blinatumomab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2017-12-15 | Issued Notice of Compliance under the NOC/c Guidance | 2019-12-19 |
| 283004 | Blinatumomab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-02-26 | Issued Notice of Compliance | 2024-12-27 |
| 211317 | Bosutinib | Antineoplastic agents | Not applicable |
2018-02-15 | Issued Notice of Compliance | 2018-12-10 |
| 213996 | Brentuximab vedotin | Antineoplastic agents | Not applicable |
2018-04-19 | Issued Notice of Compliance | 2018-12-21 |
| 216513 | Brentuximab vedotin | Antineoplastic agents | Not applicable |
2018-07-06 | Issued Notice of Compliance | 2019-05-02 |
| 227030 | Brentuximab vedotin | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2019-05-27 | Issued Notice of Compliance | 2019-11-22 |
| 268334 | Brentuximab vedotin | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2022-12-01 | Cancelled by sponsor | 2023-09-13 |
| 205854 | Brexpiprazole | Psycholeptics | Not applicable |
2017-07-07 | Issued Notice of Compliance | 2019-02-22 |
| 257995 | Brexpiprazole | Psycholeptics | Not applicable |
2021-12-17 | Cancelled by sponsor | 2022-06-17 |
| 272694 | Brexpiprazole | Psycholeptics | Not applicable |
2023-04-12 | Issued Notice of Compliance | 2024-01-23 |
| 262249 | Brexucabtagene autoleucel | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2022-04-12 | Issued Notice of Compliance | 2022-11-16 |
| 237680 | Brigatinib | Antineoplastic agents | Not applicable |
2020-05-11 | Issued Notice of Compliance | 2021-03-03 |
| 226734 | Brivaracetam | Antiepileptics | Not applicable |
2019-05-29 | Issued Notice of Compliance | 2020-03-24 |
| 259754 | Brolucizumab | Ophthalmologicals | Part of an 'aligned review' with a health technology assessment organization |
2022-02-04 | Issued Notice of Compliance | 2022-11-30 |
| 218994 | Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | Not applicable |
2018-09-18 | Cancelled by sponsor | 2020-03-18 |
| 238101 | Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | Part of an 'aligned review' with a health technology assessment organization |
2020-05-20 | Issued Notice of Compliance | 2021-03-16 |
| 220998 | Budesonide, formoterol fumarate dihydrate | Drugs for obstructive airway diseases | Not applicable |
2018-11-29 | Issued Notice of Compliance | 2019-09-25 |
| 292450 | Buprenorphine | Other nervous system drugs | Not applicable |
2025-01-10 | Issued Notice of Compliance | 2025-12-02 |
| 229313 | Burosumab | Drugs for treatment of bone diseases | Not applicable |
2019-08-22 | Issued Notice of Compliance | 2020-06-16 |
| 249112 | Burosumab | Drugs for treatment of bone diseases | Being reviewed under the Priority Review Policy |
2021-03-05 | Issued Notice of Compliance | 2021-08-26 |
| 197440 | C1 esterase inhibitor (human) | Other hematological agents | Not applicable |
2016-09-15 | Issued Notice of Compliance | 2017-03-31 |
| 254233 | Cabotegravir, rilpivirine | Antivirals for systemic use | Not applicable |
2021-08-19 | Issued Notice of Compliance | 2022-06-15 |
| 258574 | Cabotegravir, rilpivirine | Antivirals for systemic use | Not applicable |
2022-02-14 | Issued Notice of Compliance | 2022-12-09 |
| 221859 | Cabozantinib | Antineoplastic agents | Not applicable |
2018-12-19 | Issued Notice of Compliance | 2019-10-10 |
| 222733 | Cabozantinib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2019-01-14 | Issued Notice of Compliance | 2019-11-08 |
| 245824 | Cabozantinib | Antineoplastic agents | Not applicable |
2020-12-18 | Issued Notice of Compliance | 2021-10-12 |
| 257143 | Cabozantinib malate | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2021-11-04 | Issued Notice of Compliance | 2022-04-28 |
| 280615 | Cabozantinib malate | Antineoplastic agents | Not applicable |
2023-11-23 | Issued Notice of Compliance | 2024-09-12 |
| 194762 | Canagliflozin | Drugs used in diabetes | Not applicable |
2016-06-24 | Issued Notice of Compliance | 2017-04-13 |
| 210676 | Canagliflozin | Drugs used in diabetes | Not applicable |
2017-12-20 | Issued Notice of Compliance | 2018-10-15 |
| 229188 | Canagliflozin | Drugs used in diabetes | Being reviewed under the Priority Review Policy |
2019-08-02 | Issued Notice of Compliance | 2020-01-24 |
| 210969 | Canagliflozin, metformin hydrochloride | Drugs used in diabetes | Not applicable |
2017-12-21 | Issued Notice of Compliance | 2018-10-16 |
| 232307 | Canagliflozin, metformin hydrochloride | Drugs used in diabetes | Not applicable |
2019-11-15 | Issued Notice of Compliance | 2020-08-20 |
| 195617 | Canakinumab | Immunosuppressants | Being reviewed under the Priority Review Policy |
2016-07-12 | Issued Notice of Compliance | 2017-01-06 |
| 237113 | Canakinumab | Immunosuppressants | Not applicable |
2020-04-29 | Issued Notice of Compliance | 2021-02-22 |
| 225949 | Carbetocin | Pituitary and hypothalamic hormones and analogues | Not applicable |
2019-05-02 | Issued Notice of Compliance | 2020-02-24 |
| 237196 | Carfilzomib | Antineoplastic agents | Not applicable |
2020-04-08 | Issued Notice of Compliance | 2021-01-29 |
| 267413 | Carfilzomib | Antineoplastic agents | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-10-07 | Issued Notice of Compliance | 2023-07-26 |
| 227936 | Carglumic acid | Other alimentary tract and metabolism products | Being reviewed under the Priority Review Policy |
2019-06-18 | Issued Notice of Compliance | 2020-11-06 |
| 224729 | Ceftolozane, tazobactam sodium | Antibacterials for systemic use | Being reviewed under the Priority Review Policy |
2019-03-07 | Issued Notice of Compliance | 2019-08-30 |
| 246918 | Cemiplimab | Antineoplastic agents | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-12-31 | Issued Notice of Compliance | 2021-10-26 |
| 256178 | Cemiplimab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2021-09-29 | Issued Notice of Compliance | 2022-03-23 |
| 263700 | Cemiplimab | Antineoplastic agents | Not applicable |
2022-05-20 | Issued Notice of Compliance | 2023-04-27 |
| 299840 | Cemiplimab | Antineoplastic agents | Not applicable |
2025-08-29 | Issued Notice of Compliance | 2026-06-23 |
| 209082 | Certolizumab pegol | Immunosuppressants | Not applicable |
2017-10-23 | Issued Notice of Compliance | 2018-08-16 |
| 222049 | Certolizumab pegol | Immunosuppressants | Not applicable |
2019-01-17 | Issued Notice of Compliance | 2019-11-13 |
| 259446 | ChAdOx1-S (recombinant) *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-12-10 | Cancelled by sponsor | 2022-03-31 |
| 290364 | Chikungunya virus live-attenuated | Vaccines | Not applicable |
2024-10-18 | Issued Notice of Compliance | 2025-08-14 |
| 265382 | Cilgavimab, tixagevimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2022-06-22 | Issued Notice of Compliance | 2022-10-18 |
| 277017 | Ciltacabtagene autoleucel | Antineoplastic agents | Not applicable |
2023-08-23 | Issued Notice of Compliance | 2024-07-19 |
| 258126 | Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | Not applicable |
2021-12-16 | Issued Notice of Compliance | 2022-10-12 |
| 274244 | Coagulation factor VIII (human), human plasma proteins, Von Willebrand factor (human) | Antihemorrhagics | Not applicable |
2023-05-03 | Issued Notice of Compliance | 2024-02-27 |
| 195789 | Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | Not applicable |
2016-07-28 | Issued Notice of Compliance | 2017-05-25 |
| 207251 | Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | Not applicable |
2017-08-23 | Issued Notice of Compliance | 2018-06-19 |
| 219784 | Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | Not applicable |
2018-10-04 | Issued Notice of Compliance | 2019-07-19 |
| 202488 | Collagenase clostridium histolyticum | Other drugs for disorders of the musculo-skeletal system | Not applicable |
2017-03-08 | Issued Notice of Compliance | 2018-01-02 |
| 285411 | Concizumab | Antihemorrhagics | Not applicable |
2024-05-03 | Cancelled by sponsor | 2024-06-07 |
| 216208 | Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F | Vaccines | Not applicable |
2018-06-19 | Issued Notice of Compliance | 2019-04-15 |
| 270922 | 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 | Being reviewed under the Priority Review Policy |
2023-01-23 | Issued Notice of Compliance | 2023-07-21 |
| 259725 | 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 | Being reviewed under the Priority Review Policy |
2022-01-14 | Issued Notice of Compliance | 2022-07-08 |
| 291819 | Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, 35B, deOAc15B | Vaccines | Not applicable |
2024-11-22 | Issued Notice of Compliance | 2025-10-14 |
| 240171 | Crisaborole | Other dermatological preparations | Not applicable |
2020-07-17 | Issued Notice of Compliance | 2021-05-18 |
| 198322 | Crizotinib | Antineoplastic agents | Not applicable |
2016-11-01 | Issued Notice of Compliance | 2017-08-28 |
| 199381 | Dabrafenib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2016-11-10 | Issued Notice of Compliance | 2017-05-16 |
| 210753 | Dabrafenib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2017-11-22 | Issued Notice of Compliance | 2018-05-18 |
| 213581 | Dabrafenib | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2018-03-18 | Issued Notice of Compliance | 2018-09-21 |
| 270381 | Dabrafenib mesylate | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-30 | Issued Notice of Compliance | 2023-07-26 |
| 278103 | Dalbavancin | Antibacterials for systemic use | Not applicable |
2023-09-28 | Issued Notice of Compliance | 2024-07-24 |
| 227213 | Dapagliflozin propanediol | Drugs used in diabetes | Not applicable |
2019-06-10 | Issued Notice of Compliance | 2020-04-02 |
| 234304 | Dapagliflozin propanediol | Drugs used in diabetes | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-01-02 | Issued Notice of Compliance | 2020-06-30 |
| 248367 | Dapagliflozin propanediol | Drugs used in diabetes | Being reviewed under the Priority Review Policy |
2021-02-11 | Issued Notice of Compliance | 2021-08-10 |
| 268982 | Dapagliflozin propanediol monohydrate | Drugs used in diabetes | Not applicable |
2022-12-16 | Issued Notice of Compliance | 2023-10-11 |
| 228055 | Dapagliflozin, metformin hydrochloride | Drugs used in diabetes | Not applicable |
2019-07-08 | Issued Notice of Compliance | 2020-04-23 |
| 214792 | Daptomycin | Antibacterials for systemic use | Not applicable |
2018-05-11 | Issued Notice of Compliance | 2019-02-21 |
| 198647 | Daratumumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2016-10-17 | Issued Notice of Compliance | 2017-04-13 |
| 212559 | Daratumumab | Antineoplastic agents | Not applicable |
2018-01-31 | Issued Notice of Compliance | 2018-11-27 |
| 226512 | Daratumumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-05-03 | Issued Notice of Compliance | 2019-10-25 |
| 234407 | Daratumumab | Antineoplastic agents | Not applicable |
2020-01-27 | Issued Notice of Compliance | 2020-11-17 |
| 244119 | Daratumumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2020-11-02 | Issued Notice of Compliance | 2021-04-12 |
| 249815 | Daratumumab | Antineoplastic agents | Not applicable |
2021-03-29 | Issued Notice of Compliance | 2022-01-21 |
| 259880 | Daratumumab | Antineoplastic agents | Not applicable |
2022-02-14 | Issued Notice of Compliance | 2022-12-08 |
| 286426 | Daratumumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2024-05-31 | Issued Notice of Compliance | 2024-11-27 |
| 293030 | Daratumumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2025-01-23 | Issued Notice of Compliance | 2025-11-18 |
| 262749 | Darolutamide | Endocrine therapy | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2022-04-20 | Issued Notice of Compliance | 2022-09-29 |
| 291388 | Darolutamide | Endocrine therapy | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-11-13 | Issued Notice of Compliance | 2025-08-18 |
| 273747 | Davesomeran, elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2023-03-31 | Issued Notice of Compliance | 2023-05-18 |
| 274717 | Davesomeran, elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2023-05-03 | Cancelled by sponsor | 2023-10-26 |
| 244597 | Deferiprone | All other therapeutic products | Not applicable |
2020-12-18 | Issued Notice of Compliance | 2021-10-13 |
| 261912 | Deferiprone | All other therapeutic products | Not applicable |
2022-06-03 | Issued Notice of Compliance | 2023-03-30 |
| 203717 | Denosumab | Drugs for treatment of bone diseases | Not applicable |
2017-04-19 | Issued Notice of Compliance | 2018-02-13 |
| 205235 | Denosumab | Drugs for treatment of bone diseases | Not applicable |
2017-06-08 | Issued Notice of Compliance | 2018-04-04 |
| 241617 | Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | Not applicable |
2020-09-10 | Issued Notice of Compliance | 2022-12-29 |
| 285056 | Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | Not applicable |
2024-05-09 | Issued Notice of Compliance | 2025-03-05 |
| 215955 | Dexlansoprazole | Drugs for acid related disorders | Not applicable |
2018-06-14 | Issued Notice of Compliance | 2019-04-02 |
| 259869 | Dimethyl fumarate | Immunosuppressants | Not applicable |
2022-04-14 | Issued Notice of Compliance | 2023-05-18 |
| 243463 | 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 | Not applicable |
2020-10-02 | Issued Notice of Compliance | 2021-08-05 |
| 243456 | Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed | Vaccines | Not applicable |
2020-10-02 | Issued Notice of Compliance | 2021-08-05 |
| 220233 | 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 | Not applicable |
2018-11-02 | Issued Notice of Compliance | 2020-09-28 |
| 220103 | Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid | Vaccines | Not applicable |
2018-11-02 | Issued Notice of Compliance | 2020-09-28 |
| 207076 | Dolutegravir | Antivirals for systemic use | Not applicable |
2017-08-09 | Issued Notice of Compliance | 2018-05-22 |
| 235583 | Dolutegravir | Antivirals for systemic use | Not applicable |
2020-04-02 | Issued Notice of Compliance | 2021-01-27 |
| 264733 | Doravirine | Antivirals for systemic use | Not applicable |
2022-07-22 | Issued Notice of Compliance | 2023-05-30 |
| 266249 | Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | Not applicable |
2022-09-12 | Issued Notice of Compliance | 2023-07-06 |
| 274515 | Dostarlimab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2023-05-19 | Issued Notice of Compliance | 2023-11-15 |
| 286361 | Dostarlimab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-06-20 | Issued Notice of Compliance | 2025-04-16 |
| 201964 | Dulaglutide | Drugs used in diabetes | Not applicable |
2017-03-03 | Issued Notice of Compliance | 2017-12-22 |
| 232128 | Dulaglutide | Drugs used in diabetes | Not applicable |
2019-11-18 | Issued Notice of Compliance | 2020-09-11 |
| 221043 | Dupilumab | Other dermatological preparations | Not applicable |
2018-11-30 | Issued Notice of Compliance | 2019-09-25 |
| 231268 | Dupilumab | Other dermatological preparations | Not applicable |
2019-10-18 | Issued Notice of Compliance | 2020-08-12 |
| 234105 | Dupilumab | Other dermatological preparations | Not applicable |
2020-01-17 | Issued Notice of Compliance | 2020-11-12 |
| 237081 | Dupilumab | Other dermatological preparations | Biosimilar |
2020-03-17 | Issued Notice of Compliance | 2021-02-22 |
| 252306 | Dupilumab | Other dermatological preparations | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-05-31 | Issued Notice of Compliance | 2022-03-25 |
| 264439 | Dupilumab | Other dermatological preparations | Not applicable |
2022-06-20 | Issued Notice of Compliance | 2023-04-14 |
| 268311 | Dupilumab | Other dermatological preparations | Being reviewed under the Priority Review Policy |
2022-11-02 | Issued Notice of Compliance | 2023-05-01 |
| 266537 | Dupilumab | Other dermatological preparations | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-09-16 | Issued Notice of Compliance | 2023-07-12 |
| 283782 | Dupilumab | Other dermatological preparations | Being reviewed under the Priority Review Policy |
2024-03-11 | Issued Notice of Compliance | 2024-09-06 |
| 286477 | Dupilumab | Other dermatological preparations | Not applicable |
2024-06-06 | Issued Notice of Compliance | 2025-10-21 |
| 292407 | Dupilumab | Other dermatological preparations | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-01-03 | Issued Notice of Compliance | 2025-10-27 |
| 233107 | Durvalumab | Antineoplastic agents | Not applicable |
2019-11-27 | Issued Notice of Compliance | 2020-09-21 |
| 262782 | Durvalumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2022-04-21 | Issued Notice of Compliance | 2022-09-28 |
| 281318 | Durvalumab | Endocrine therapy | Not applicable |
2024-01-12 | Issued Notice of Compliance | 2024-10-08 |
| 282097 | Durvalumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-01-30 | Issued Notice of Compliance | 2025-01-17 |
| 290251 | Durvalumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-10-10 | Issued Notice of Compliance | 2025-04-08 |
| 285745 | Durvalumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-05-30 | Issued Notice of Compliance | 2025-04-10 |
| 292883 | Durvalumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-01-03 | Issued Notice of Compliance | 2025-07-17 |
| 299521 | Durvalumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-07-30 | Issued Notice of Compliance | 2026-01-22 |
| 281503 | Durvalumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-01-16 | Issued Notice of Compliance | 2026-02-20 |
| 212987 | Eculizumab | Immunosuppressants | Being reviewed under the Priority Review Policy |
2018-02-21 | Issued Notice of Compliance | 2018-08-20 |
| 225847 | Eculizumab | Immunosuppressants | Being reviewed under the Priority Review Policy |
2019-04-01 | Issued Notice of Compliance | 2019-09-24 |
| 288497 | Eculizumab | Immunosuppressants | Not applicable |
2024-08-29 | Issued Notice of Compliance | 2025-08-07 |
| 307001 | Eculizumab | Immunosuppressants | Biosimilar |
2026-04-16 | Issued Notice of Compliance | 2026-07-02 |
| 292379 | Efgartigimod alfa | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2025-01-08 | Issued Notice of Compliance | 2025-11-03 |
| 253430 | Elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-06-04 | Authorized under Interim Order | 2021-08-27 |
| 257293 | Elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-10-06 | Issued Notice of Compliance | 2021-11-12 |
| 258658 | Elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-11-16 | Issued Notice of Compliance | 2022-03-17 |
| 263775 | Elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-04-29 | Issued Notice of Compliance | 2022-07-14 |
| 262952 | Elasomeran *For use in relation to COVID-19 | Vaccines | Being reviewed under the Submissions Relying on Third-Party Data Guidance For use in relation to COVID-19 |
2022-04-21 | Cancelled by sponsor | 2022-09-16 |
| 262408 | Elasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-03-16 | Issued Notice of Compliance | 2023-01-12 |
| 269428 | Elasomeran, imelasomeran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-11-24 | Issued Notice of Compliance | 2023-02-17 |
| 255136 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2021-10-22 | Issued Notice of Compliance | 2022-04-20 |
| 271750 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-04-14 | Issued Notice of Compliance | 2023-10-16 |
| 282009 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2024-01-16 | Issued Notice of Compliance | 2024-07-12 |
| 195798 | Eltrombopag olamine | Antihemorrhagics | Not applicable |
2016-07-05 | Issued Notice of Compliance | 2017-05-01 |
| 217802 | Eltrombopag olamine | Antihemorrhagics | Not applicable |
2018-07-31 | Issued Notice of Compliance | 2019-05-15 |
| 216004 | Eltrombopag olamine | Antihemorrhagics | Not applicable |
2018-06-19 | Cancelled by sponsor | 2019-06-27 |
| 222209 | Emicizumab | Antihemorrhagics | Being reviewed under the Priority Review Policy |
2018-12-18 | Issued Notice of Compliance | 2019-06-14 |
| 193840 | Empagliflozin | Drugs used in diabetes | Not applicable |
2016-05-20 | Issued Notice of Compliance | 2018-04-16 |
| 221628 | Empagliflozin | Drugs used in diabetes | Not applicable |
2019-01-15 | Issued Notice of Compliance | 2019-04-18 |
| 246457 | Empagliflozin | Drugs used in diabetes | Not applicable |
2021-01-04 | Issued Notice of Compliance | 2021-10-29 |
| 256491 | Empagliflozin | Drugs used in diabetes | Being reviewed under the Priority Review Policy |
2021-10-08 | Issued Notice of Compliance | 2022-04-06 |
| 270652 | Empagliflozin | Drugs used in diabetes | Not applicable |
2023-03-24 | Issued Notice of Compliance | 2024-01-18 |
| 204589 | Empagliflozin, linagliptin | Drugs used in diabetes | Not applicable |
2017-06-09 | Issued Notice of Compliance | 2018-04-20 |
| 234525 | Emtricitabine, tenofovir alafenamide | Antivirals for systemic use | Not applicable |
2020-02-03 | Issued Notice of Compliance | 2020-11-27 |
| 292474 | Encorafenib | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type B |
2024-12-17 | Issued Notice of Compliance under the NOC/c Guidance | 2025-07-25 |
| 283003 | Enfortumab vedotin | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-02-22 | Issued Notice of Compliance | 2024-08-20 |
| 304157 | Enfortumab vedotin | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-12-30 | Issued Notice of Compliance | 2026-06-26 |
| 209807 | Enoxaparin sodium | Antithrombotic agents | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2017-11-15 | Issued Notice of Compliance | 2018-09-11 |
| 292028 | Enoxaparin sodium | Antithrombotic agents | Not applicable |
2024-12-27 | Cancelled by sponsor | 2025-08-22 |
| 216719 | Enzalutamide | Endocrine therapy | Being reviewed under the Priority Review Policy |
2018-06-25 | Issued Notice of Compliance | 2018-12-20 |
| 233563 | Enzalutamide | Endocrine therapy | Being reviewed under the Priority Review Policy |
2019-12-10 | Issued Notice of Compliance | 2020-06-02 |
| 277282 | Enzalutamide | Endocrine therapy | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2023-08-17 | Issued Notice of Compliance | 2024-01-05 |
| 200866 | Eptacog alfa | Antihemorrhagics | Not applicable |
2017-01-17 | Issued Notice of Compliance | 2017-11-10 |
| 267878 | Eptacog alfa | Antihemorrhagics | Not applicable |
2022-11-07 | Cancelled by sponsor | 2023-03-15 |
| 197739 | Eribulin mesylate | Antineoplastic agents | Not applicable |
2016-10-14 | Issued Notice of Compliance | 2017-08-04 |
| 194018 | Erlotinib hydrochloride | Antineoplastic agents | Not applicable |
2016-06-02 | Issued Notice of Compliance | 2017-03-29 |
| 244338 | Esketamine hydrochloride | Psychoanaleptics | Not applicable |
2020-11-12 | Issued Notice of Compliance | 2021-09-02 |
| 208086 | Eslicarbazepine acetate | Antiepileptics | Not applicable |
2017-09-18 | Issued Notice of Compliance | 2018-06-25 |
| 209753 | Eslicarbazepine acetate | Antiepileptics | Not applicable |
2017-11-16 | Issued Notice of Compliance | 2018-09-12 |
| 193787 | Etanercept | Immunosuppressants | Not applicable |
2016-05-18 | Issued Notice of Compliance | 2017-03-14 |
| 213347 | Etanercept | Immunosuppressants | Biosimilar |
2018-03-23 | Issued Notice of Compliance | 2019-01-17 |
| 226145 | Etanercept | Immunosuppressants | Biosimilar |
2019-05-13 | Issued Notice of Compliance | 2020-06-09 |
| 231313 | Etanercept | Immunosuppressants | Biosimilar |
2019-10-25 | Issued Notice of Compliance | 2020-08-19 |
| 200814 | Everolimus | Antineoplastic agents | Not applicable |
2017-01-23 | Issued Notice of Compliance | 2017-11-17 |
| 291743 | Evinacumab | Lipid modifying agents | Being reviewed under the Priority Review Policy |
2024-11-20 | Issued Notice of Compliance | 2025-07-04 |
| 207038 | Evolocumab | Lipid modifying agents | Not applicable |
2017-08-10 | Issued Notice of Compliance | 2018-06-05 |
| 208904 | Evolocumab | Lipid modifying agents | Not applicable |
2017-10-16 | Issued Notice of Compliance | 2018-08-10 |
| 247936 | Evolocumab | Lipid modifying agents | Not applicable |
2021-02-12 | Issued Notice of Compliance | 2021-12-09 |
| 208034 | Exenatide | Drugs used in diabetes | Not applicable |
2017-09-19 | Issued Notice of Compliance | 2018-07-04 |
| 268826 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-10-27 | Issued Notice of Compliance | 2022-12-09 |
| 274152 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2023-03-31 | Issued Notice of Compliance | 2023-07-06 |
| 275559 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2023-06-09 | Issued Notice of Compliance | 2023-08-31 |
| 278042 | Faricimab | Ophthalmologicals | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-09-29 | Issued Notice of Compliance | 2024-07-24 |
| 230407 | Fibrinogen (human) | Antihemorrhagics | Not applicable |
2019-09-20 | Issued Notice of Compliance | 2020-07-16 |
| 227551 | Fibrinogen (human) | Antihemorrhagics | Not applicable |
2019-06-26 | Cancelled by sponsor | 2020-11-30 |
| 281380 | Fibrinogen (human), thrombin (human) | Antihemorrhagics | Not applicable |
2024-01-15 | Issued Notice of Compliance | 2024-11-18 |
| 295025 | Finerenone | Diuretics | Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-03-26 | Issued Notice of Compliance | 2026-01-19 |
| 215423 | Fingolimod hydrochloride | Immunosuppressants | Being reviewed under the Priority Review Policy |
2018-05-11 | Issued Notice of Compliance | 2018-11-07 |
| 229727 | Flibanserin | Other gynecologicals | Not applicable |
2019-07-26 | Issued Notice of Compliance | 2021-01-27 |
| 208727 | Fluticasone furoate | Drugs for obstructive airway diseases | Not applicable |
2017-10-20 | Cancelled by sponsor | 2018-10-24 |
| 215148 | Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | Not applicable |
2018-05-24 | Issued Notice of Compliance | 2019-03-20 |
| 240101 | Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | Not applicable |
2020-07-15 | Issued Notice of Compliance | 2021-05-11 |
| 291390 | Follitropin alfa, lutropin alfa | Sex hormones and modulators of the genital system | Not applicable |
2024-11-25 | Issued Notice of Compliance | 2025-08-11 |
| 239493 | Formoterol fumarate dihydrate, mometasone furoate | Drugs for obstructive airway diseases | Not applicable |
2020-06-29 | Issued Notice of Compliance | 2021-04-23 |
| 256308 | Fosfomycin sodium | Antibacterials for systemic use | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-12-07 | Issued Notice of Compliance | 2022-10-18 |
| 295245 | Fremanezumab | Analgesics | Not applicable |
2025-04-07 | Issued Notice of Compliance | 2026-01-30 |
| 201150 | Fulvestrant | Endocrine therapy | Part of an 'aligned review' with a health technology assessment organization |
2017-01-17 | Issued Notice of Compliance | 2017-11-08 |
| 205610 | Gadoterate meglumine | Contrast media | Not applicable |
2017-06-28 | Issued Notice of Compliance | 2018-04-24 |
| 252254 | Gadoteridol | Contrast media | Not applicable |
2021-07-28 | Issued Notice of Compliance | 2022-05-24 |
| 232324 | Galcanezumab | Analgesics | Not applicable |
2019-11-22 | Issued Notice of Compliance | 2020-09-17 |
| 279567 | Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | Not applicable |
2023-11-24 | Issued Notice of Compliance | 2024-09-20 |
| 222816 | Glecaprevir, pibrentasvir | Antivirals for systemic use | Being reviewed under the Priority Review Policy |
2018-12-31 | Issued Notice of Compliance | 2019-06-25 |
| 247707 | Glecaprevir, pibrentasvir | Antivirals for systemic use | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-02-02 | Issued Notice of Compliance | 2021-11-29 |
| 298254 | Glecaprevir, pibrentasvir | Antivirals for systemic use | Being reviewed under the Priority Review Policy |
2025-06-23 | Issued Notice of Compliance | 2025-12-18 |
| 289989 | Glofitamab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-10-21 | Issued Notice of Compliance | 2025-08-13 |
| 259175 | Glycerol phenylbutyrate | Other alimentary tract and metabolism products | Not applicable |
2022-02-07 | Issued Notice of Compliance | 2022-11-24 |
| 198552 | Glycopyrronium bromide, indacaterol maleate | Drugs for obstructive airway diseases | Not applicable |
2016-11-07 | Issued Notice of Compliance | 2017-08-31 |
| 197362 | Golimumab | Immunosuppressants | Not applicable |
2016-09-23 | Issued Notice of Compliance | 2017-06-28 |
| 205724 | Golimumab | Immunosuppressants | Not applicable |
2017-06-09 | Issued Notice of Compliance | 2018-04-05 |
| 255908 | Golimumab | Immunosuppressants | Not applicable |
2021-10-07 | Issued Notice of Compliance | 2022-07-29 |
| 275599 | Goserelin acetate | Endocrine therapy | Not applicable |
2023-07-11 | Issued Notice of Compliance | 2024-05-06 |
| 232124 | Guselkumab | Immunosuppressants | Not applicable |
2019-11-15 | Issued Notice of Compliance | 2020-09-04 |
| 288802 | Guselkumab | Immunosuppressants | Not applicable |
2024-09-13 | Issued Notice of Compliance | 2025-07-07 |
| 285952 | Guselkumab | Immunosuppressants | Not applicable |
2024-06-06 | Issued Notice of Compliance | 2025-09-03 |
| 293414 | Guselkumab | Immunosuppressants | Not applicable |
2025-01-21 | Issued Notice of Compliance | 2025-11-17 |
| 199807 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2016-11-21 | Issued Notice of Compliance | 2017-05-30 |
| 295102 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | Not applicable |
2025-04-03 | Issued Notice of Compliance | 2026-01-27 |
| 225528 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | Not applicable |
2019-04-26 | Issued Notice of Compliance | 2020-02-20 |
| 229325 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | Not applicable |
2019-08-21 | Issued Notice of Compliance | 2020-06-16 |
| 238479 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | Not applicable |
2020-05-12 | Issued Notice of Compliance | 2021-03-08 |
| 246936 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | Not applicable |
2021-01-14 | Issued Notice of Compliance | 2021-11-30 |
| 251147 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | Not applicable |
2021-05-19 | Issued Notice of Compliance | 2022-03-08 |
| 218188 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) | Vaccines | Not applicable |
2018-08-23 | Cancelled by sponsor | 2019-06-19 |
| 273436 | Hexaminolevulinate hydrochloride | Diagnostic agents | Not applicable |
2023-05-12 | Issued Notice of Compliance | 2024-03-21 |
| 208033 | Human immunoglobulin | Immune sera and immunoglobulins | Not applicable |
2017-09-15 | Issued Notice of Compliance | 2018-07-12 |
| 276884 | Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | Not applicable |
2023-08-17 | Issued Notice of Compliance | 2024-06-11 |
| 276541 | Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | Not applicable |
2023-08-01 | Issued Notice of Compliance | 2025-03-13 |
| 223245 | Hydromorphone hydrochloride | Analgesics | Being reviewed under the Priority Review Policy Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-01-22 | Issued Notice of Compliance | 2019-05-01 |
| 223031 | Hydroxyethyl starch | Blood substitutes and perfusion solutions | Not applicable |
2019-04-24 | Issued Notice of Compliance | 2020-02-18 |
| 222938 | Hydroxyethyl starch | Blood substitutes and perfusion solutions | Not applicable |
2019-04-24 | Issued Notice of Compliance | 2020-02-18 |
| 226144 | Hydroxyurea | Antineoplastic agents | Not applicable |
2019-04-17 | Issued Notice of Compliance | 2020-02-10 |
| 204436 | Ibrutinib | Immunosuppressants | Being reviewed under the Priority Review Policy |
2017-05-01 | Issued Notice of Compliance | 2017-10-25 |
| 212632 | Ibrutinib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2018-02-01 | Issued Notice of Compliance | 2018-07-24 |
| 218457 | Ibrutinib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2018-08-16 | Issued Notice of Compliance | 2019-02-11 |
| 222804 | Ibrutinib | Antineoplastic agents | Not applicable |
2019-01-11 | Issued Notice of Compliance | 2019-11-06 |
| 235706 | Ibrutinib | Antineoplastic agents | Reviewed under Project Orbis Type B |
2020-02-20 | Issued Notice of Compliance | 2020-12-15 |
| 263702 | Ibrutinib | Antineoplastic agents | Not applicable |
2022-05-30 | Issued Notice of Compliance | 2023-03-20 |
| 266710 | Ibrutinib | Antineoplastic agents | Not applicable |
2022-10-13 | Issued Notice of Compliance | 2023-08-04 |
| 217805 | Icatibant acetate | Other hematological agents | Not applicable |
2018-09-12 | Issued Notice of Compliance | 2019-06-28 |
| 203513 | Idelalisib | Antineoplastic agents | Not applicable |
2017-04-26 | Cancelled by sponsor | 2017-12-07 |
| 201326 | Immunoglobulin (human) | Immune sera and immunoglobulins | Not applicable |
2017-01-23 | Issued Notice of Compliance | 2017-10-04 |
| 223557 | Immunoglobulin (human) | Immune sera and immunoglobulins | Not applicable |
2019-02-27 | Cancelled by sponsor | 2019-11-27 |
| 240691 | Immunoglobulin (human) | Immune sera and immunoglobulins | Not applicable |
2020-07-24 | Issued Notice of Compliance | 2021-05-19 |
| 253256 | Immunoglobulin (human) | Immune sera and immunoglobulins | Not applicable |
2021-07-23 | Issued Notice of Compliance | 2022-05-19 |
| 208713 | Incobotulinumtoxina | Muscle relaxants | Not applicable |
2017-10-02 | Issued Notice of Compliance | 2019-06-18 |
| 234438 | Incobotulinumtoxina | Muscle relaxants | Not applicable |
2020-01-22 | Issued Notice of Compliance | 2020-11-17 |
| 251521 | Incobotulinumtoxina | Muscle relaxants | Not applicable |
2021-05-13 | Issued Notice of Compliance | 2022-03-15 |
| 257192 | Incobotulinumtoxina | Muscle relaxants | Not applicable |
2021-11-19 | Issued Notice of Compliance | 2022-09-22 |
| 268590 | Incobotulinumtoxina | Muscle relaxants | Not applicable |
2022-11-04 | Cancelled by sponsor | 2023-10-06 |
| 278522 | Incobotulinumtoxina | Muscle relaxants | Not applicable |
2023-10-12 | Issued Notice of Compliance | 2024-12-11 |
| 292615 | Inebilizumab | Immunosuppressants | Being reviewed under the Priority Review Policy |
2024-12-16 | Issued Notice of Compliance | 2025-06-13 |
| 298552 | Inebilizumab | Immunosuppressants | Not applicable |
2025-07-25 | Issued Notice of Compliance | 2026-05-19 |
| 220321 | Infliximab | Immunosuppressants | Biosimilar |
2018-11-02 | Issued Notice of Compliance | 2019-08-28 |
| 236086 | Infliximab | Immunosuppressants | Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2020-04-03 | Issued Notice of Compliance | 2021-01-28 |
| 262141 | Infliximab | Immunosuppressants | Biosimilar |
2022-04-29 | Issued Notice of Compliance | 2023-03-07 |
| 272981 | Infliximab | Immunosuppressants | Biosimilar |
2023-04-21 | Issued Notice of Compliance | 2024-02-15 |
| 226586 | Insulin aspart | Drugs used in diabetes | Not applicable |
2019-05-03 | Issued Notice of Compliance | 2020-02-26 |
| 254352 | Insulin aspart | Drugs used in diabetes | Biosimilar |
2021-10-01 | Issued Notice of Compliance | 2022-07-20 |
| 208917 | Insulin degludec | Drugs used in diabetes | Not applicable |
2017-10-27 | Issued Notice of Compliance | 2018-07-17 |
| 234406 | Insulin degludec, liraglutide | Drugs used in diabetes | Not applicable |
2020-01-21 | Issued Notice of Compliance | 2020-11-13 |
| 228382 | Insulin glargine | Drugs used in diabetes | Not applicable |
2019-07-17 | Issued Notice of Compliance | 2020-05-12 |
| 232504 | Insulin glargine, lixisenatide | Drugs used in diabetes | Not applicable |
2019-11-29 | Issued Notice of Compliance | 2020-09-17 |
| 268527 | Iohexol | Contrast media | Not applicable |
2023-03-06 | Issued Notice of Compliance | 2023-12-29 |
| 202533 | Ipilimumab | Antineoplastic agents | Not applicable |
2017-02-13 | Issued Notice of Compliance | 2017-04-13 |
| 255450 | Ipilimumab | Antineoplastic agents | Not applicable |
2021-09-23 | Issued Notice of Compliance | 2022-03-03 |
| 270801 | Ipilimumab | Antineoplastic agents | Not applicable |
2023-02-09 | Issued Notice of Compliance | 2023-12-07 |
| 297990 | Iptacopan hydrochloride | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2025-07-04 | Issued Notice of Compliance | 2026-04-30 |
| 244601 | Isatuximab | Antineoplastic agents | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-10-30 | Issued Notice of Compliance | 2021-09-13 |
| 286449 | Isatuximab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-06-21 | Issued Notice of Compliance | 2025-04-17 |
| 299488 | Isatuximab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2025-08-18 | Issued Notice of Compliance | 2026-06-10 |
| 280928 | Isavuconazonium sulfate | Antimycotics for systemic use | Not applicable |
2023-12-28 | Issued Notice of Compliance | 2024-11-15 |
| 218044 | Ivacaftor | Other respiratory system products | Biosimilar |
2018-08-03 | Issued Notice of Compliance | 2019-01-25 |
| 247481 | Ivacaftor | Other respiratory system products | Being reviewed under the Priority Review Policy |
2021-02-26 | Issued Notice of Compliance | 2021-08-25 |
| 255781 | Ivacaftor | Other respiratory system products | Being reviewed under the Priority Review Policy |
2021-09-14 | Issued Notice of Compliance | 2022-03-23 |
| 273575 | Ivacaftor | Other respiratory system products | Being reviewed under the Priority Review Policy |
2023-06-01 | Issued Notice of Compliance | 2023-11-28 |
| 198036 | Ivacaftor, lumacaftor | Other respiratory system products | Biosimilar |
2016-10-20 | Issued Notice of Compliance | 2017-04-18 |
| 215032 | Ivacaftor, lumacaftor | Other respiratory system products | Biosimilar |
2018-06-15 | Issued Notice of Compliance | 2018-12-11 |
| 264825 | Ivacaftor, lumacaftor | Other respiratory system products | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-07-08 | Issued Notice of Compliance | 2023-04-06 |
| 204690 | Ixekizumab | Immunosuppressants | Not applicable |
2017-06-05 | Issued Notice of Compliance | 2018-03-29 |
| 225178 | Ixekizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2019-04-17 | Issued Notice of Compliance | 2020-02-04 |
| 233071 | Ixekizumab | Immunosuppressants | Not applicable |
2019-12-20 | Issued Notice of Compliance | 2020-10-14 |
| 238580 | Ixekizumab | Immunosuppressants | Not applicable |
2020-06-02 | Issued Notice of Compliance | 2021-03-29 |
| 203520 | Japanese encephalitis virus vaccine inactivated | Vaccines | Not applicable |
2017-05-08 | Issued Notice of Compliance | 2018-03-02 |
| 193732 | Lacosamide | Antiepileptics | Not applicable |
2016-05-04 | Issued Notice of Compliance | 2017-02-28 |
| 294771 | Lanadelumab | Other hematological agents | Not applicable |
2025-03-17 | Issued Notice of Compliance | 2026-03-02 |
| 203094 | Lanreotide acetate | Pituitary and hypothalamic hormones and analogues | Not applicable |
2017-04-10 | Issued Notice of Compliance | 2018-02-02 |
| 199607 | Ledipasvir, sofosbuvir | Antivirals for systemic use | Biosimilar |
2016-11-24 | Issued Notice of Compliance | 2017-05-24 |
| 197794 | Lenvatinib mesylate | Antineoplastic agents | Not applicable |
2016-11-17 | Issued Notice of Compliance | 2017-09-13 |
| 212989 | Lenvatinib mesylate | Antineoplastic agents | Not applicable |
2018-02-27 | Issued Notice of Compliance | 2018-12-19 |
| 228723 | Lenvatinib mesylate | Antineoplastic agents | Reviewed under Project Orbis Type A |
2019-07-09 | Issued Notice of Compliance under the NOC/c Guidance | 2019-09-20 |
| 252195 | Lenvatinib mesylate | Antineoplastic agents | Not applicable |
2021-06-07 | Cancelled by sponsor | 2022-02-24 |
| 253057 | Lenvatinib mesylate | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2021-07-12 | Issued Notice of Compliance | 2022-05-05 |
| 272553 | Letermovir | Antivirals for systemic use | Being reviewed under the Priority Review Policy |
2023-03-28 | Issued Notice of Compliance | 2023-09-21 |
| 193372 | Leuprolide acetate | Endocrine therapy | Not applicable |
2016-05-05 | Issued Notice of Compliance | 2017-02-10 |
| 269016 | Leuprolide acetate | Endocrine therapy | Not applicable |
2022-12-02 | Issued Notice of Compliance | 2023-09-21 |
| 254192 | Leuprolide acetate | Endocrine therapy | Not applicable |
2021-10-14 | Issued Notice of Compliance | 2024-01-12 |
| 290766 | Leuprolide acetate | Endocrine therapy | Not applicable |
2025-01-21 | Issued Notice of Compliance | 2025-11-13 |
| 222857 | Levomilnacipran | Psychoanaleptics | Not applicable |
2019-01-22 | Issued Notice of Compliance | 2019-11-15 |
| 204355 | Levonorgestrel | Sex hormones and modulators of the genital system | Not applicable |
2017-05-19 | Issued Notice of Compliance | 2018-03-14 |
| 273103 | Levonorgestrel | Other gynecologicals | Not applicable |
2023-04-28 | Issued Notice of Compliance | 2024-02-20 |
| 279169 | Linaclotide | Drugs for constipation | Not applicable |
2023-11-10 | Issued Notice of Compliance | 2024-09-05 |
| 194075 | Linagliptin | Drugs used in diabetes | Not applicable |
2016-06-03 | Issued Notice of Compliance | 2018-10-11 |
| 222572 | Linagliptin | Drugs used in diabetes | Not applicable |
2019-01-16 | Issued Notice of Compliance | 2019-11-08 |
| 194067 | Linagliptin, metformin hydrochloride | Drugs used in diabetes | Not applicable |
2016-06-03 | Cancelled by sponsor | 2017-05-02 |
| 229225 | Linagliptin, metformin hydrochloride | Drugs used in diabetes | Not applicable |
2019-08-22 | Issued Notice of Compliance | 2020-06-15 |
| 196457 | Liraglutide | Drugs used in diabetes | Not applicable |
2016-08-19 | Issued Notice of Compliance | 2017-06-15 |
| 200821 | Liraglutide | Drugs used in diabetes | Not applicable |
2017-01-23 | Issued Notice of Compliance | 2017-11-17 |
| 225809 | Liraglutide | Drugs used in diabetes | Not applicable |
2019-05-03 | Issued Notice of Compliance | 2020-02-26 |
| 237880 | Liraglutide | Drugs used in diabetes | Not applicable |
2020-05-01 | Issued Notice of Compliance | 2021-02-25 |
| 279827 | Lisocabtagene maraleucel | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2023-11-30 | Issued Notice of Compliance | 2024-09-25 |
| 247174 | Lorlatinib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2021-01-11 | Issued Notice of Compliance | 2021-06-07 |
| 265088 | Lumasiran sodium | Other alimentary tract and metabolism products | Not applicable |
2022-07-28 | Issued Notice of Compliance | 2023-05-12 |
| 197342 | Lurasidone hydrochloride | Psycholeptics | Not applicable |
2016-09-23 | Issued Notice of Compliance | 2017-07-20 |
| 205325 | Lurasidone hydrochloride | Psycholeptics | Not applicable |
2017-06-23 | Issued Notice of Compliance | 2018-04-19 |
| 279552 | Luspatercept | Antianemic preparations | Not applicable |
2023-11-20 | Issued Notice of Compliance | 2024-09-13 |
| 282347 | Lutetium (177Lu) oxodotreotide | Therapeutic radiopharmaceuticals | Not applicable |
2024-02-09 | Issued Notice of Compliance | 2024-12-13 |
| 219599 | Macitentan | Antihypertensives | Not applicable |
2018-11-22 | Cancelled by sponsor | 2019-11-08 |
| 221389 | Macitentan | Antihypertensives | Not applicable |
2019-01-04 | Issued Notice of Compliance | 2020-07-23 |
| 282456 | Macitentan | Antihypertensives | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2024-02-09 | Issued Notice of Compliance | 2025-09-12 |
| 292796 | Maralixibat chloride | Bile and liver therapy | Part of an 'aligned review' with a health technology assessment organization |
2025-04-07 | Issued Notice of Compliance | 2026-01-30 |
| 272517 | Mavacamten | Cardiac therapy | Not applicable |
2023-04-06 | Issued Notice of Compliance | 2024-02-16 |
| 296376 | Meningococcal groups A, C, Y, and W polysaccharide-tetanus toxoid conjugate | Vaccines | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-05-16 | Issued Notice of Compliance | 2026-03-26 |
| 203844 | Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid | Vaccines | Not applicable |
2017-04-25 | Issued Notice of Compliance | 2018-02-19 |
| 208467 | Mepolizumab | Drugs for obstructive airway diseases | Not applicable |
2017-09-20 | Issued Notice of Compliance | 2018-07-17 |
| 212242 | Mepolizumab | Drugs for obstructive airway diseases | Not applicable |
2018-02-02 | Cancelled by sponsor | 2018-10-18 |
| 221528 | Mepolizumab | Drugs for obstructive airway diseases | Not applicable |
2018-12-12 | Issued Notice of Compliance | 2019-10-08 |
| 226197 | Mepolizumab | Drugs for obstructive airway diseases | Not applicable |
2019-05-17 | Issued Notice of Compliance | 2020-03-12 |
| 247542 | Mepolizumab | Drugs for obstructive airway diseases | Not applicable |
2021-01-14 | Issued Notice of Compliance | 2021-11-05 |
| 293315 | Mepolizumab | Drugs for obstructive airway diseases | Part of an 'aligned review' with a health technology assessment organization |
2025-01-22 | Issued Notice of Compliance | 2026-06-09 |
| 255153 | Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | Not applicable |
2021-09-17 | Issued Notice of Compliance | 2022-08-08 |
| 262828 | Methyl aminolevulinate hydrochloride | Antineoplastic agents | Not applicable |
2022-04-29 | Issued Notice of Compliance | 2023-02-17 |
| 214860 | Methylphenidate hydrochloride | Psychoanaleptics | Not applicable |
2018-05-11 | Issued Notice of Compliance | 2019-03-05 |
| 224342 | Methylphenidate hydrochloride | Psychoanaleptics | Not applicable |
2019-03-21 | Issued Notice of Compliance | 2020-01-15 |
| 210496 | Midostaurin | Antineoplastic agents | Not applicable |
2017-12-07 | Issued Notice of Compliance | 2018-10-03 |
| 200856 | Mifepristone, misoprostol | Sex hormones and modulators of the genital system | Not applicable |
2017-01-11 | Issued Notice of Compliance | 2017-11-07 |
| 262810 | Migalastat hydrochloride | Other alimentary tract and metabolism products | Not applicable |
2022-05-12 | Issued Notice of Compliance | 2023-03-23 |
| 288758 | Mirikizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2024-09-11 | Issued Notice of Compliance | 2025-07-08 |
| 195973 | Nadroparin calcium | Antithrombotic agents | Not applicable |
2016-08-05 | Issued Notice of Compliance | 2017-07-19 |
| 221031 | Naloxegol oxalate | Drugs for constipation | Not applicable |
2018-11-27 | Cancelled by sponsor | 2019-09-27 |
| 242449 | Neratinib maleate | Antineoplastic agents | Not applicable |
2020-09-03 | Issued Notice of Compliance | 2021-06-23 |
| 211052 | Nilotinib | Antineoplastic agents | Not applicable |
2017-12-21 | Issued Notice of Compliance | 2018-10-16 |
| 227166 | Nintedanib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2019-05-28 | Issued Notice of Compliance | 2019-11-22 |
| 232923 | Nintedanib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2019-11-29 | Issued Notice of Compliance | 2020-05-20 |
| 241747 | Nintedanib | Antineoplastic agents | Not applicable |
2020-08-31 | Issued Notice of Compliance | 2021-06-25 |
| 237670 | Niraparib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-04-08 | Issued Notice of Compliance | 2020-10-02 |
| 199379 | Nivolumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2016-11-15 | Issued Notice of Compliance | 2017-05-12 |
| 203286 | Nivolumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2017-03-17 | Issued Notice of Compliance | 2017-11-10 |
| 203593 | Nivolumab | Antineoplastic agents | Not applicable |
2017-04-20 | Cancelled by sponsor | 2018-01-25 |
| 206974 | Nivolumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2017-07-14 | Issued Notice of Compliance under the NOC/c Guidance | 2018-03-23 |
| 212067 | Nivolumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2018-01-08 | Issued Notice of Compliance | 2018-07-06 |
| 211838 | Nivolumab | Antineoplastic agents | Not applicable |
2018-01-19 | Issued Notice of Compliance | 2018-11-15 |
| 215535 | Nivolumab | Antineoplastic agents | Not applicable |
2018-06-04 | Cancelled by sponsor | 2019-11-26 |
| 236255 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type A |
2020-03-18 | Issued Notice of Compliance | 2020-08-06 |
| 234228 | Nivolumab | Antineoplastic agents | Not applicable |
2020-01-24 | Issued Notice of Compliance | 2020-11-18 |
| 239474 | Nivolumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2020-06-01 | Issued Notice of Compliance under the NOC/c Guidance | 2021-02-11 |
| 243600 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2020-09-30 | Issued Notice of Compliance | 2021-05-28 |
| 247045 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2021-01-08 | Issued Notice of Compliance | 2021-07-02 |
| 245851 | Nivolumab | Antineoplastic agents | Not applicable |
2020-12-18 | Issued Notice of Compliance | 2021-10-13 |
| 247339 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2021-01-12 | Issued Notice of Compliance | 2021-10-28 |
| 253652 | Nivolumab | Antineoplastic agents | Not applicable |
2021-07-29 | Issued Notice of Compliance under the NOC/c Guidance | 2022-06-27 |
| 257103 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2021-11-17 | Issued Notice of Compliance | 2022-07-25 |
| 261300 | Nivolumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2022-03-10 | Issued Notice of Compliance | 2022-08-18 |
| 272504 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type C |
2023-03-31 | Issued Notice of Compliance | 2023-12-29 |
| 282374 | Nivolumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2024-01-03 | Issued Notice of Compliance | 2024-06-28 |
| 288843 | Nivolumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-08-23 | Issued Notice of Compliance | 2025-06-19 |
| 289379 | Nivolumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-09-19 | Issued Notice of Compliance | 2025-07-16 |
| 282961 | Nivolumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2024-03-07 | Issued Notice of Compliance | 2026-02-09 |
| 208906 | Norfloxacin | Antibacterials for systemic use | Not applicable |
2017-10-06 | Issued Notice of Compliance | 2017-12-05 |
| 208089 | Obinutuzumab | Antineoplastic agents | Not applicable |
2017-09-08 | Issued Notice of Compliance | 2018-07-05 |
| 295777 | Obinutuzumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-03-28 | Issued Notice of Compliance | 2026-01-22 |
| 289602 | Odevixibat | Bile and liver therapy | Not applicable |
2024-09-26 | Issued Notice of Compliance | 2025-07-22 |
| 210204 | Olaparib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2017-11-09 | Issued Notice of Compliance | 2018-05-08 |
| 219799 | Olaparib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2018-11-19 | Issued Notice of Compliance | 2019-05-06 |
| 230309 | Olaparib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-08-23 | Issued Notice of Compliance | 2020-02-14 |
| 235698 | Olaparib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-02-27 | Issued Notice of Compliance | 2020-08-21 |
| 259417 | Olaparib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2022-01-18 | Issued Notice of Compliance under the NOC/c Guidance | 2022-07-27 |
| 265427 | Olaparib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2022-08-10 | Issued Notice of Compliance under the NOC/c Guidance | 2023-07-11 |
| 286243 | Olaparib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-05-15 | Issued Notice of Compliance | 2025-04-29 |
| 223910 | Olodaterol hydrochloride, tiotropium bromide monohydrate | Drugs for obstructive airway diseases | Not applicable |
2019-03-11 | Issued Notice of Compliance | 2019-12-06 |
| 194542 | Omalizumab | Drugs for obstructive airway diseases | Not applicable |
2016-06-16 | Issued Notice of Compliance | 2017-04-12 |
| 241064 | Omalizumab | Drugs for obstructive airway diseases | Not applicable |
2020-08-14 | Issued Notice of Compliance | 2021-07-19 |
| 195504 | Ombitasvir, paritaprevir, ritonavir | Antivirals for systemic use | Not applicable |
2016-07-11 | Issued Notice of Compliance | 2017-05-05 |
| 211053 | OnabotulinumtoxinA | Muscle relaxants | Not applicable |
2017-12-20 | Issued Notice of Compliance | 2018-10-16 |
| 237685 | OnabotulinumtoxinA | Muscle relaxants | Not applicable |
2020-05-15 | Issued Notice of Compliance | 2021-03-11 |
| 273166 | OnabotulinumtoxinA | Muscle relaxants | Not applicable |
2023-04-13 | Issued Notice of Compliance | 2024-02-07 |
| 275576 | OnabotulinumtoxinA | Muscle relaxants | Not applicable |
2023-06-28 | Cancelled by sponsor | 2024-04-23 |
| 285064 | OnabotulinumtoxinA | Muscle relaxants | Not applicable |
2024-05-08 | Issued Notice of Compliance | 2025-03-04 |
| 211762 | Osimertinib mesylate | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2018-01-12 | Issued Notice of Compliance | 2018-07-10 |
| 243288 | Osimertinib mesylate | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2020-09-15 | Issued Notice of Compliance | 2021-01-18 |
| 279138 | Osimertinib mesylate | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2023-10-17 | Issued Notice of Compliance | 2024-07-10 |
| 288417 | Osimertinib mesylate | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-08-07 | Issued Notice of Compliance under the NOC/c Guidance | 2025-04-23 |
| 209413 | 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 | Not applicable |
2017-11-02 | Issued Notice of Compliance | 2018-08-14 |
| 248992 | Ozanimod | Immunosuppressants | Not applicable |
2021-05-28 | Issued Notice of Compliance | 2022-04-08 |
| 195948 | Palbociclib | Antineoplastic agents | Not applicable |
2016-07-26 | Issued Notice of Compliance | 2017-05-19 |
| 219500 | Palbociclib | Antineoplastic agents | Not applicable |
2018-10-11 | Issued Notice of Compliance | 2019-08-06 |
| 273901 | Palbociclib | Antineoplastic agents | Not applicable |
2023-05-17 | Issued Notice of Compliance | 2024-03-07 |
| 215829 | Palonosetron hydrochloride | Antiemetics and antinauseants | Not applicable |
2018-06-14 | Issued Notice of Compliance | 2019-04-08 |
| 193962 | Panitumumab | Antineoplastic agents | Not applicable |
2016-06-09 | Issued Notice of Compliance | 2017-04-05 |
| 209345 | Pasireotide | Pituitary and hypothalamic hormones and analogues | Not applicable |
2017-11-02 | Issued Notice of Compliance | 2018-08-29 |
| 301559 | Pegcetacoplan | Immunosuppressants | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-10-10 | Issued Notice of Compliance | 2026-04-08 |
| 201200 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2017-01-13 | Issued Notice of Compliance under the NOC/c Guidance | 2017-09-08 |
| 203157 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2017-03-24 | Issued Notice of Compliance | 2017-09-20 |
| 212388 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2018-01-26 | Issued Notice of Compliance under the NOC/c Guidance | 2018-09-21 |
| 215699 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2018-05-18 | Issued Notice of Compliance | 2019-03-13 |
| 216451 | Pembrolizumab | Antineoplastic agents | Not applicable |
2018-06-06 | Issued Notice of Compliance | 2019-04-02 |
| 209011 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2017-09-25 | Issued Notice of Compliance | 2019-04-11 |
| 218779 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2018-08-22 | Issued Notice of Compliance under the NOC/c Guidance | 2019-04-18 |
| 219700 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2018-10-15 | Issued Notice of Compliance | 2019-07-04 |
| 228721 | Pembrolizumab | Antineoplastic agents | Reviewed under Project Orbis Type A |
2019-07-09 | Issued Notice of Compliance under the NOC/c Guidance | 2019-09-20 |
| 223819 | Pembrolizumab | Antineoplastic agents | Not applicable |
2019-02-18 | Issued Notice of Compliance | 2019-12-13 |
| 219213 | Pembrolizumab | Antineoplastic agents | Not applicable |
2018-09-27 | Issued Notice of Compliance | 2020-03-16 |
| 232775 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2019-12-20 | Issued Notice of Compliance | 2020-10-09 |
| 236910 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2020-04-03 | Issued Notice of Compliance under the NOC/c Guidance | 2020-12-14 |
| 239505 | Pembrolizumab | Antineoplastic agents | Reviewed under Project Orbis Type A |
2020-06-19 | Issued Notice of Compliance under the NOC/c Guidance | 2021-02-05 |
| 240864 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2020-07-29 | Issued Notice of Compliance | 2021-03-03 |
| 246922 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2020-12-15 | Issued Notice of Compliance | 2021-06-04 |
| 246373 | Pembrolizumab | Antineoplastic agents | Not applicable |
2020-12-18 | Issued Notice of Compliance under the NOC/c Guidance | 2021-11-19 |
| 252263 | Pembrolizumab | Antineoplastic agents | Not applicable |
2021-06-07 | Cancelled by sponsor | 2022-02-24 |
| 257236 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2021-11-05 | Issued Notice of Compliance | 2022-04-07 |
| 256659 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2021-10-15 | Issued Notice of Compliance | 2022-04-12 |
| 253060 | Pembrolizumab | Antineoplastic agents | Not applicable |
2021-07-12 | Issued Notice of Compliance | 2022-05-04 |
| 259703 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type C |
2022-01-05 | Issued Notice of Compliance | 2022-07-05 |
| 256537 | Pembrolizumab | Antineoplastic agents | Reviewed under Project Orbis Type B |
2021-10-22 | Issued Notice of Compliance | 2022-08-18 |
| 264318 | Pembrolizumab | Antineoplastic agents | Reviewed under Project Orbis Type C |
2022-06-24 | Issued Notice of Compliance | 2023-04-19 |
| 272409 | Pembrolizumab | Antineoplastic agents | Not applicable |
2023-03-30 | Issued Notice of Compliance | 2024-02-06 |
| 273487 | Pembrolizumab | Antineoplastic agents | Reviewed under Project Orbis Type C |
2023-05-10 | Issued Notice of Compliance | 2024-03-21 |
| 275053 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2023-06-13 | Issued Notice of Compliance | 2024-04-12 |
| 276501 | Pembrolizumab | Antineoplastic agents | Not applicable |
2023-08-03 | Issued Notice of Compliance | 2024-05-29 |
| 282981 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type C |
2024-02-22 | Issued Notice of Compliance | 2024-08-20 |
| 278399 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2023-10-13 | Issued Notice of Compliance | 2024-08-29 |
| 274453 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2023-06-06 | Issued Notice of Compliance | 2025-02-06 |
| 285469 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-05-10 | Issued Notice of Compliance | 2025-03-05 |
| 286343 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-06-17 | Issued Notice of Compliance | 2025-04-11 |
| 284571 | Pembrolizumab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-04-17 | Issued Notice of Compliance | 2025-07-14 |
| 294481 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-02-13 | Issued Notice of Compliance | 2025-08-11 |
| 302363 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2025-11-03 | Issued Notice of Compliance | 2026-04-24 |
| 303530 | Pembrolizumab | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-12-09 | Issued Notice of Compliance | 2026-06-05 |
| 204327 | Perampanel | Antiepileptics | Not applicable |
2017-05-26 | Issued Notice of Compliance | 2018-03-21 |
| 225719 | Perampanel | Antiepileptics | Not applicable |
2019-05-01 | Issued Notice of Compliance | 2020-02-25 |
| 209467 | Pertuzumab | Antineoplastic agents | Not applicable |
2017-11-03 | Issued Notice of Compliance | 2018-08-30 |
| 222022 | Pertuzumab, trastuzumab | Antineoplastic agents | Not applicable |
2018-12-12 | Issued Notice of Compliance | 2020-07-30 |
| 230602 | Pertuzumab, trastuzumab | Antineoplastic agents | Not applicable |
2019-09-25 | Issued Notice of Compliance | 2021-02-25 |
| 254251 | Pertuzumab, trastuzumab | Antineoplastic agents | Not applicable |
2021-07-28 | Issued Notice of Compliance | 2022-01-05 |
| 220947 | Pimecrolimus | Other dermatological preparations | Not applicable |
2018-11-30 | Issued Notice of Compliance | 2019-09-26 |
| 247851 | Pimecrolimus | Other dermatological preparations | Not applicable |
2021-01-05 | Cancelled by sponsor | 2023-09-14 |
| 270856 | Pitolisant hydrochloride | Other nervous system drugs | Not applicable |
2023-02-13 | Issued Notice of Compliance | 2024-01-25 |
| 284477 | Pitolisant hydrochloride | Other nervous system drugs | Not applicable |
2024-04-22 | Issued Notice of Compliance | 2025-02-14 |
| 279583 | Plecanatide | Drugs for constipation | Not applicable |
2024-01-18 | Issued Notice of Compliance | 2024-12-24 |
| 213345 | Plerixafor | Immunostimulants | Not applicable |
2018-02-01 | Issued Notice of Compliance | 2019-01-10 |
| 259726 | Polatuzumab vedotin | Antineoplastic agents | Not applicable |
2022-01-21 | Issued Notice of Compliance | 2022-11-14 |
| 218459 | Pomalidomide | Immunosuppressants | Not applicable |
2018-09-07 | Issued Notice of Compliance | 2019-07-02 |
| 201272 | Ranibizumab | Ophthalmologicals | Not applicable |
2017-01-09 | Issued Notice of Compliance | 2017-11-03 |
| 233361 | Ranibizumab | Ophthalmologicals | Not applicable |
2019-11-29 | Issued Notice of Compliance under the NOC/c Guidance | 2021-11-19 |
| 264421 | Ranolazine | Cardiac therapy | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-08-26 | Issued Notice of Compliance | 2025-06-30 |
| 259173 | Ravulizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2022-01-05 | Issued Notice of Compliance | 2022-11-01 |
| 261864 | Ravulizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2022-03-16 | Issued Notice of Compliance | 2023-01-06 |
| 269852 | Ravulizumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2023-01-03 | Issued Notice of Compliance | 2023-10-30 |
| 223244 | Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | Not applicable |
2019-02-11 | Issued Notice of Compliance | 2020-08-20 |
| 251509 | Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | Not applicable |
2021-05-28 | Issued Notice of Compliance under the NOC/c Guidance | 2022-04-06 |
| 203322 | Regorafenib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2017-04-03 | Issued Notice of Compliance | 2017-09-18 |
| 250151 | Remdesivir *For use in relation to COVID-19 | Antivirals for systemic use | For use in relation to COVID-19 |
2021-04-22 | Issued Notice of Compliance | 2022-04-22 |
| 266313 | Remdesivir *For use in relation to COVID-19 | Antivirals for systemic use | For use in relation to COVID-19 |
2022-08-02 | Issued Notice of Compliance | 2023-06-16 |
| 282013 | Respiratory syncytial virus prefusion F protein (RSVPreF3) | Vaccines | Not applicable |
2024-01-08 | Issued Notice of Compliance | 2024-11-15 |
| 298869 | Retifanlimab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2025-08-01 | Issued Notice of Compliance | 2026-05-28 |
| 225074 | Ribociclib succinate | Antineoplastic agents | Not applicable |
2019-04-16 | Issued Notice of Compliance | 2020-02-07 |
| 233623 | Ribociclib succinate | Antineoplastic agents | Not applicable |
2019-12-18 | Issued Notice of Compliance | 2020-10-09 |
| 262779 | Ribociclib succinate | Antineoplastic agents | Not applicable |
2022-04-21 | Issued Notice of Compliance | 2023-02-10 |
| 283993 | Ribociclib succinate | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-08-20 | Issued Notice of Compliance | 2025-06-12 |
| 209230 | Rifaximin | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | Not applicable |
2018-02-07 | Issued Notice of Compliance | 2018-12-03 |
| 251455 | Risankizumab | Immunosuppressants | Not applicable |
2021-05-20 | Issued Notice of Compliance | 2022-03-16 |
| 258394 | Risankizumab | Immunosuppressants | Not applicable |
2021-12-23 | Issued Notice of Compliance | 2022-10-19 |
| 280386 | Risankizumab | Immunosuppressants | Not applicable |
2023-12-15 | Issued Notice of Compliance | 2024-10-10 |
| 284770 | Risdiplam | Other drugs for disorders of the musculo-skeletal system | Being reviewed under the Priority Review Policy |
2024-04-09 | Issued Notice of Compliance | 2024-10-16 |
| 204718 | Rituximab | Antineoplastic agents | Not applicable |
2017-05-25 | Issued Notice of Compliance | 2018-03-21 |
| 228130 | Rituximab | Antineoplastic agents | Biosimilar |
2019-07-19 | Issued Notice of Compliance | 2020-05-22 |
| 242572 | Rituximab | Antineoplastic agents | Biosimilar |
2020-09-24 | Issued Notice of Compliance | 2021-06-30 |
| 211611 | Rivaroxaban | Antithrombotic agents | Being reviewed under the Priority Review Policy |
2018-01-12 | Issued Notice of Compliance | 2018-09-14 |
| 233166 | Rivaroxaban | Antithrombotic agents | Not applicable |
2020-02-04 | Issued Notice of Compliance | 2020-11-27 |
| 234756 | Rivaroxaban | Antithrombotic agents | Not applicable |
2020-03-19 | Issued Notice of Compliance | 2021-01-12 |
| 306377 | Rivastigmine hydrogen tartrate | Psychoanaleptics | Not applicable |
2026-03-12 | Issued Notice of Compliance | 2026-07-02 |
| 280534 | Roflumilast | Antipsoriatics | Not applicable |
2023-12-22 | Issued Notice of Compliance | 2024-10-17 |
| 285437 | Roflumilast | Antipsoriatics | Not applicable |
2024-05-17 | Issued Notice of Compliance | 2025-03-13 |
| 292646 | Roflumilast | Antipsoriatics | Not applicable |
2025-01-16 | Issued Notice of Compliance | 2025-11-12 |
| 243699 | Romiplostim | Antihemorrhagics | Not applicable |
2020-10-09 | Issued Notice of Compliance | 2021-08-04 |
| 262756 | Romosozumab | Drugs for treatment of bone diseases | Not applicable |
2022-05-09 | Cancelled by sponsor | 2023-03-21 |
| 294768 | RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) | Vaccines | Not applicable |
2025-03-20 | Issued Notice of Compliance | 2026-01-14 |
| 290813 | RSV subgroups A, B stabilized prefusion F protein | Vaccines | Not applicable |
2024-12-13 | Issued Notice of Compliance | 2025-10-17 |
| 194343 | Rufinamide | Antiepileptics | Not applicable |
2016-06-24 | Issued Notice of Compliance | 2017-04-20 |
| 250022 | Ruxolitinib phosphate | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2021-03-24 | Issued Notice of Compliance | 2022-05-19 |
| 292164 | Ruxolitinib phosphate | Other dermatological preparations | Not applicable |
2024-12-13 | Issued Notice of Compliance | 2025-10-09 |
| 270849 | Sacituzumab govitecan | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2023-01-20 | Issued Notice of Compliance | 2023-07-19 |
| 211993 | Sarilumab | Immunosuppressants | Not applicable |
2018-01-26 | Issued Notice of Compliance | 2019-08-08 |
| 287263 | Sarilumab | Immunosuppressants | Not applicable |
2024-07-16 | Issued Notice of Compliance | 2025-05-09 |
| 266285 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-07-22 | Issued Notice of Compliance | 2022-11-17 |
| 265342 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-06-21 | Issued Notice of Compliance | 2022-12-06 |
| 273313 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2023-03-16 | Cancelled by sponsor | 2023-11-09 |
| 219231 | Secukinumab | Immunosuppressants | Not applicable |
2018-09-28 | Issued Notice of Compliance | 2019-07-25 |
| 235994 | Secukinumab | Immunosuppressants | Not applicable |
2020-03-26 | Issued Notice of Compliance | 2021-01-20 |
| 240496 | Secukinumab | Immunosuppressants | Not applicable |
2020-07-30 | Issued Notice of Compliance | 2021-05-26 |
| 250272 | Secukinumab | Immunosuppressants | Not applicable |
2021-05-06 | Issued Notice of Compliance | 2022-03-01 |
| 257230 | Secukinumab | Immunosuppressants | Not applicable |
2021-11-24 | Issued Notice of Compliance | 2022-09-20 |
| 269287 | Secukinumab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2022-12-23 | Issued Notice of Compliance | 2024-05-17 |
| 296426 | Selumetinib sulfate | Antineoplastic agents | Not applicable |
2025-05-06 | Issued Notice of Compliance | 2026-02-25 |
| 299525 | Selumetinib sulfate | Antineoplastic agents | Not applicable |
2025-09-05 | Issued Notice of Compliance | 2026-07-02 |
| 227387 | Semaglutide | Drugs used in diabetes | Not applicable |
2019-06-20 | Cancelled by sponsor | 2020-03-06 |
| 231580 | Semaglutide | Drugs used in diabetes | Not applicable |
2019-10-11 | Issued Notice of Compliance | 2020-08-04 |
| 245932 | Semaglutide | Drugs used in diabetes | Not applicable |
2020-12-17 | Issued Notice of Compliance | 2021-10-13 |
| 266244 | Semaglutide | Drugs used in diabetes | Not applicable |
2022-09-02 | Issued Notice of Compliance | 2023-06-29 |
| 279915 | Semaglutide | Drugs used in diabetes | Not applicable |
2023-12-07 | Issued Notice of Compliance | 2024-11-25 |
| 284023 | Semaglutide | Drugs used in diabetes | Not applicable |
2024-05-30 | Issued Notice of Compliance | 2025-04-08 |
| 287074 | Semaglutide | Drugs used in diabetes | Not applicable |
2024-07-15 | Issued Notice of Compliance | 2025-08-13 |
| 296143 | Semaglutide | Drugs used in diabetes | Being reviewed under the Priority Review Policy |
2025-04-08 | Issued Notice of Compliance under the NOC/c Guidance | 2025-12-10 |
| 295001 | Semaglutide | Drugs used in diabetes | Not applicable |
2025-03-07 | Issued Notice of Compliance | 2025-12-31 |
| 282056 | Semaglutide | Drugs used in diabetes | Not applicable |
2024-02-05 | Issued Notice of Compliance | 2026-02-25 |
| 295858 | Semaglutide | Drugs used in diabetes | Not applicable |
2025-04-28 | Issued Notice of Compliance | 2026-04-14 |
| 211598 | Sevelamer carbonate | All other therapeutic products | Not applicable |
2018-04-13 | Issued Notice of Compliance | 2019-02-07 |
| 197253 | Simeprevir | Antivirals for systemic use | Not applicable |
2016-09-23 | Issued Notice of Compliance | 2017-07-20 |
| 199753 | Sofosbuvir, velpatasvir | Antivirals for systemic use | Not applicable |
2016-12-06 | Issued Notice of Compliance | 2017-09-14 |
| 233923 | Sofosbuvir, velpatasvir | Antivirals for systemic use | Not applicable |
2020-01-16 | Issued Notice of Compliance | 2020-11-06 |
| 205985 | Somatropin | Pituitary and hypothalamic hormones and analogues | Not applicable |
2017-06-29 | Issued Notice of Compliance | 2018-04-24 |
| 241147 | Somatropin | Pituitary and hypothalamic hormones and analogues | Not applicable |
2020-08-14 | Issued Notice of Compliance | 2021-06-09 |
| 229726 | Somatropin R-DNA origin | Pituitary and hypothalamic hormones and analogues | Not applicable |
2019-08-28 | Issued Notice of Compliance | 2020-06-22 |
| 298213 | Sotatercept | Antihypertensives | Being reviewed under the Priority Review Policy |
2025-06-06 | Issued Notice of Compliance | 2025-12-03 |
| 278317 | Spesolimab | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2023-10-06 | Issued Notice of Compliance | 2024-07-31 |
| 287138 | Standardized allergen extract, white birch (Betula verrucosa) | Allergens | Not applicable |
2024-07-08 | Issued Notice of Compliance | 2025-05-02 |
| 234565 | Standardized short ragweed pollen allergenic extract | Allergens | Not applicable |
2020-02-24 | Issued Notice of Compliance | 2020-12-18 |
| 234372 | Sugammadex | All other therapeutic products | Not applicable |
2020-01-27 | Issued Notice of Compliance | 2021-10-19 |
| 289615 | Sugammadex | All other therapeutic products | Not applicable |
2024-10-04 | Issued Notice of Compliance | 2025-07-31 |
| 231944 | Sulfur hexafluoride | Contrast media | Not applicable |
2019-11-07 | Issued Notice of Compliance | 2020-08-20 |
| 208710 | Sunitinib malate | Antineoplastic agents | Not applicable |
2017-10-05 | Issued Notice of Non-compliance - Withdrawal | 2019-04-23 |
| 297626 | Tafasitamab | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-06-23 | Issued Notice of Compliance | 2026-04-17 |
| 271537 | Talazoparib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2023-05-09 | Issued Notice of Compliance | 2025-01-30 |
| 300037 | Tarlatamab | Antineoplastic agents | Reviewed under Project Orbis Type A |
2025-09-03 | Issued Notice of Compliance | 2026-06-25 |
| 305225 | Teclistamab | Antineoplastic agents | Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2026-02-03 | Issued Notice of Compliance | 2026-07-31 |
| 223862 | Teduglutide | Other alimentary tract and metabolism products | Being reviewed under the Priority Review Policy |
2019-02-15 | Issued Notice of Compliance | 2019-08-13 |
| 288031 | Tenecteplase | Antithrombotic agents | Not applicable |
2024-08-14 | Issued Notice of Compliance | 2025-11-13 |
| 231739 | Teriflunomide | Immunosuppressants | Not applicable |
2019-11-07 | Issued Notice of Compliance | 2020-09-02 |
| 295190 | Tezepelumab | Drugs for obstructive airway diseases | Part of an 'aligned review' with a health technology assessment organization |
2025-04-03 | Issued Notice of Compliance | 2026-02-09 |
| 199259 | Thioguanine | Antineoplastic agents | Not applicable |
2016-11-25 | Issued Notice of Compliance | 2017-09-21 |
| 231818 | Ticagrelor | Antithrombotic agents | Not applicable |
2019-10-31 | Issued Notice of Compliance | 2020-08-26 |
| 199839 | Tinzaparin sodium | Antithrombotic agents | Not applicable |
2016-12-19 | Cancelled by sponsor | 2018-11-22 |
| 227070 | Tipiracil hydrochloride, trifluridine | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2019-05-24 | Issued Notice of Compliance | 2019-11-19 |
| 293412 | Tirzepatide | Drugs used in diabetes | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-02-06 | Cancelled by sponsor | 2025-11-26 |
| 299409 | Tirzepatide | Drugs used in diabetes | Part of an 'aligned review' with a health technology assessment organization |
2025-08-15 | Issued Notice of Compliance | 2026-06-11 |
| 300244 | Tirzepatide | Drugs used in diabetes | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-08-29 | Issued Notice of Compliance | 2026-06-23 |
| 263500 | Tisagenlecleucel | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2022-05-20 | Issued Notice of Compliance under the NOC/c Guidance | 2022-12-19 |
| 204251 | Tocilizumab | Immunosuppressants | Being reviewed under the Priority Review Policy |
2017-05-01 | Issued Notice of Compliance | 2017-10-27 |
| 219690 | Tocilizumab | Immunosuppressants | Not applicable |
2018-10-02 | Issued Notice of Compliance | 2019-07-29 |
| 220039 | Tocilizumab | Immunosuppressants | Not applicable |
2018-10-22 | Issued Notice of Compliance | 2019-08-16 |
| 261220 | Tocilizumab *For use in relation to COVID-19 | Immunosuppressants | For use in relation to COVID-19 |
2022-02-04 | Issued Notice of Compliance | 2022-10-13 |
| 209522 | Tofacitinib | Immunosuppressants | Not applicable |
2017-11-15 | Issued Notice of Compliance | 2018-09-11 |
| 209643 | Tofacitinib | Immunosuppressants | Not applicable |
2017-12-08 | Issued Notice of Compliance | 2018-10-04 |
| 213578 | Tofacitinib | Immunosuppressants | Not applicable |
2018-04-07 | Issued Notice of Compliance | 2019-01-30 |
| 264582 | Tofacitinib citrate | Immunosuppressants | Not applicable |
2022-07-15 | Issued Notice of Compliance | 2023-05-12 |
| 271059 | Tofacitinib citrate | Immunosuppressants | Not applicable |
2023-03-28 | Issued Notice of Compliance | 2024-04-12 |
| 213262 | Tolvaptan | Diuretics | Not applicable |
2018-03-15 | Issued Notice of Compliance | 2019-01-19 |
| 251730 | Tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-04-16 | Authorized under Interim Order | 2021-05-05 |
| 257162 | Tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-10-01 | Issued Notice of Compliance | 2021-11-09 |
| 257698 | Tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2021-10-18 | Issued Notice of Compliance | 2021-11-19 |
| 261729 | Tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-02-23 | Issued Notice of Compliance | 2022-06-01 |
| 264621 | Tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-05-27 | Issued Notice of Compliance | 2022-08-19 |
| 265483 | Tozinameran *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-06-23 | Issued Notice of Compliance | 2022-09-09 |
| 261661 | Tralokinumab | Other dermatological preparations | Part of an 'aligned review' with a health technology assessment organization |
2022-04-13 | Issued Notice of Compliance | 2023-02-03 |
| 199382 | Trametinib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2016-11-17 | Issued Notice of Compliance | 2017-05-16 |
| 210760 | Trametinib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2017-11-22 | Issued Notice of Compliance | 2018-05-18 |
| 213580 | Trametinib | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance |
2018-03-08 | Issued Notice of Compliance | 2018-09-21 |
| 270386 | Trametinib | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-27 | Issued Notice of Compliance | 2023-07-24 |
| 226272 | Trastuzumab | Antineoplastic agents | Biosimilar |
2019-04-11 | Issued Notice of Compliance | 2019-08-15 |
| 239083 | Trastuzumab | Antineoplastic agents | Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2020-06-17 | Issued Notice of Compliance | 2021-04-14 |
| 242479 | Trastuzumab | Antineoplastic agents | Biosimilar |
2020-09-24 | Issued Notice of Compliance | 2021-04-14 |
| 237674 | Trastuzumab | Antineoplastic agents | Biosimilar |
2020-05-29 | Issued Notice of Compliance | 2021-04-16 |
| 247842 | Trastuzumab | Antineoplastic agents | Biosimilar |
2021-02-11 | Issued Notice of Compliance | 2021-12-06 |
| 259440 | Trastuzumab deruxtecan | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2022-01-06 | Issued Notice of Compliance | 2022-06-15 |
| 265333 | Trastuzumab deruxtecan | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2022-07-15 | Issued Notice of Compliance | 2023-01-06 |
| 285834 | Trastuzumab deruxtecan | Antineoplastic agents | Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2024-05-14 | Issued Notice of Compliance | 2025-01-17 |
| 288114 | Trastuzumab deruxtecan | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-08-07 | Issued Notice of Compliance under the NOC/c Guidance | 2025-07-03 |
| 291846 | Trastuzumab deruxtecan | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-12-19 | Issued Notice of Compliance | 2025-10-27 |
| 227372 | Trastuzumab emtansine | Antineoplastic agents | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-05-30 | Issued Notice of Compliance | 2019-11-25 |
| 282179 | Treosulfan | Antineoplastic agents | Not applicable |
2024-03-14 | Cancelled by sponsor | 2025-07-02 |
| 235656 | Tretinoin | Anti-acne preparations | Not applicable |
2020-03-16 | Issued Notice of Compliance | 2021-01-08 |
| 222505 | Umeclidinium bromide | Drugs for obstructive airway diseases | Not applicable |
2019-01-16 | Issued Notice of Compliance | 2020-09-23 |
| 241253 | Upadacitinib | Immunosuppressants | Not applicable |
2020-08-10 | Issued Notice of Compliance | 2021-06-03 |
| 245530 | Upadacitinib | Immunosuppressants | Not applicable |
2020-12-10 | Issued Notice of Compliance | 2021-10-06 |
| 247702 | Upadacitinib | Immunosuppressants | Not applicable |
2021-02-03 | Issued Notice of Compliance | 2022-07-14 |
| 264612 | Upadacitinib | Immunosuppressants | Not applicable |
2022-07-15 | Issued Notice of Compliance | 2023-05-02 |
| 257284 | Upadacitinib | Immunosuppressants | Part of an 'aligned review' with a health technology assessment organization |
2021-12-17 | Issued Notice of Compliance | 2023-07-21 |
| 267554 | Upadacitinib | Immunosuppressants | Not applicable |
2022-12-16 | Issued Notice of Compliance | 2023-10-12 |
| 290301 | Upadacitinib | Immunosuppressants | Not applicable |
2024-10-30 | Issued Notice of Compliance | 2025-08-21 |
| 224739 | Ustekinumab | Immunosuppressants | Not applicable |
2019-03-29 | Issued Notice of Compliance | 2020-01-23 |
| 230279 | Ustekinumab | Immunosuppressants | Not applicable |
2019-08-21 | Issued Notice of Compliance | 2020-06-16 |
| 285419 | Ustekinumab | Immunosuppressants | Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-05-17 | Issued Notice of Compliance | 2024-11-13 |
| 289290 | Ustekinumab | Immunosuppressants | Biosimilar |
2024-09-25 | Issued Notice of Compliance | 2025-02-28 |
| 291252 | Ustekinumab | Immunosuppressants | Biosimilar |
2024-12-06 | Issued Notice of Compliance | 2025-06-04 |
| 296870 | Ustekinumab | Immunosuppressants | Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2025-07-15 | Issued Notice of Compliance | 2026-02-02 |
| 246933 | Varicella-zoster virus glycoprotein E (GE) | Vaccines | Not applicable |
2021-01-14 | Issued Notice of Compliance | 2021-11-24 |
| 214078 | Venetoclax | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2018-03-27 | Issued Notice of Compliance | 2018-09-21 |
| 228475 | Venetoclax | Antineoplastic agents | Not applicable |
2019-07-04 | Issued Notice of Compliance | 2020-04-28 |
| 240541 | Venetoclax | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2020-06-17 | Issued Notice of Compliance | 2020-12-04 |
| 289982 | Venetoclax | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2024-10-08 | Issued Notice of Compliance | 2025-07-31 |
| 299192 | Venetoclax | Antineoplastic agents | Not applicable |
2025-08-07 | Issued Notice of Compliance | 2026-04-28 |
| 210066 | Vilazodone hydrochloride | Psychoanaleptics | Not applicable |
2017-11-27 | Cancelled by sponsor | 2018-10-24 |
| 267448 | Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 | Vaccines | For use in relation to COVID-19 |
2022-08-30 | Issued Notice of Compliance | 2023-03-30 |
| 294120 | Vutrisiran sodium | Other nervous system drugs | Part of an 'aligned review' with a health technology assessment organization |
2025-02-17 | Issued Notice of Compliance | 2025-12-12 |
| 254556 | Zanubrutinib | Antineoplastic agents | Being reviewed under the Priority Review Policy |
2021-09-01 | Issued Notice of Compliance | 2022-02-18 |
| 264963 | Zanubrutinib | Antineoplastic agents | Part of an 'aligned review' with a health technology assessment organization |
2022-07-29 | Issued Notice of Compliance | 2023-05-24 |
| 273215 | Zanubrutinib | Antineoplastic agents | Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-04-12 | Issued Notice of Compliance | 2024-02-02 |