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

This list is current as of: 2025-03-31.

An Excel version of the updated SUR List is available from the Overview page.

Submissions formerly under review: New drug submissions
Submission Control Number Medicinal Ingredient(s) Therapeutic Area Year, Month Submission was Accepted into Review Outcome of Submission (Hyperlinked if applicable)Footnote a Year, Month Submission Concluded
234673 5-aminolevulinic acid Antineoplastic agents 2020-03 Issued Notice of Compliance 2020-09
259301 Abaloparatide Calcium homeostasis 2022-03 Cancelled by sponsor 2023-01
215268 Abemaciclib Antineoplastic agents 2018-06 Issued Notice of Compliance 2019-04
265223 Abiraterone acetate, niraparib Endocrine therapy 2022-08 Issued Notice of Compliance under the NOC/c Guidance 2023-06
245854 Abrocitinib Other dermatological preparations 2020-12 Issued Notice of Compliance 2022-06
214504 Acalabrutinib Antineoplastic agents 2018-04 Issued Notice of Compliance 2019-08
259246 Acalabrutinib Antineoplastic agents 2022-05 Issued Notice of Compliance 2023-02
209478 Acetaminophen Analgesics 2018-02 Issued Notice of Compliance 2018-11
244695 Acetaminophen Analgesics 2021-04 Issued Notice of Compliance 2023-02
260262 Acetaminophen, ibuprofen sodium dihydrate Analgesics 2022-06 Issued Notice of Compliance 2024-02
234460 Acetylsalicylic acid, atorvastatin calcium, ramipril Cardiac therapy 2020-02 Cancelled by sponsor 2021-03
246758 Ad26.COV2.s (recombinant) *For use in relation to COVID-19 Vaccines 2020-11 Authorized under Interim Order 2021-03
253702 Ad26.COV2.s (recombinant) *For use in relation to COVID-19 Vaccines 2021-07 Issued Notice of Compliance 2021-11
203250 Adalimumab Immunosuppressants 2017-04 Issued Notice of Compliance 2018-05
203292 Adalimumab Immunosuppressants 2017-04 Issued Notice of Compliance 2018-05
230637 Adalimumab Immunosuppressants 2019-10 Issued Notice of Compliance 2020-10
229124 Adalimumab Immunosuppressants 2019-09 Issued Notice of Compliance 2020-11
217314 Adalimumab Immunosuppressants 2018-11 Issued Notice of Compliance 2020-11
235685 Adalimumab Immunosuppressants 2020-03 Issued Notice of Compliance 2021-01
247265 Adalimumab Immunosuppressants 2021-03 Issued Notice of Compliance 2021-12
244990 Adalimumab Immunosuppressants 2021-02 Issued Notice of Compliance 2022-01
271199 Adapalene, benzoyl peroxide, clindamycin phosphate Anti-acne preparations 2023-10 Issued Notice of Compliance 2024-08
251005 Aducanumab Other nervous system drugs 2021-06 Cancelled by sponsor 2022-05
189442 Alectinib Antineoplastic agents 2016-02 Issued Notice of Compliance under the NOC/c Guidance 2016-09
246730 Alfa 1-proteinase inhibitor (human) Antihemorrhagics 2021-01 Issued Notice of Compliance 2021-11
183116 Alirocumab Lipid modifying agents 2015-06 Issued Notice of Compliance 2016-04
226941 Alpelisib Antineoplastic agents 2019-05 Issued Notice of Compliance 2020-03
273683 Alpha1-proteinase inhibitor (human) Antihemorrhagics 2023-05 Issued Notice of Compliance 2023-11
189825 Alvimopan Drugs for constipation 2016-03 Cancelled by sponsor 2017-03
234655 Amifampridine Other nervous system drugs 2020-02 Issued Notice of Compliance 2023-01
232685 Amifampridine phosphate Other nervous system drugs 2020-02 Issued Notice of Compliance 2020-07
235705 Amisulpride Psycholeptics 2020-03 Cancelled by sponsor 2021-01
254440 Amivantamab Antineoplastic agents 2021-07 Issued Notice of Compliance under the NOC/c Guidance 2022-03
211854 Amlodipine besylate Calcium channel blockers 2018-07 Issued Notice of Compliance 2019-01
221964 Amoxicillin sodium, clavulanic acid Antibacterials for systemic use 2019-04 Issued Notice of Compliance 2020-01
266464 Andexanet alfa All other therapeutic products 2022-10 Issued Notice of Compliance under the NOC/c Guidance 2023-06
275936 Andusomeran *For use in relation to COVID-19 Vaccines 2023-06 Issued Notice of Compliance 2023-09
246187 Anifrolumab Immunosuppressants 2020-12 Issued Notice of Compliance 2021-11
212387 Anthrax antigen filtrate Vaccines 2018-02 Issued Notice of Compliance 2018-12
200446 Anthrax immunoglobulin (human) Immune sera and immunoglobulins 2017-01 Issued Notice of Compliance 2017-11
194071 Antihemophilic factor (human), von Willebrand factor (human) Antihemorrhagics 2016-06 Issued Notice of Compliance 2018-05
189709 Antihemophilic factor (recombinant), pegylated Antihemorrhagics 2016-01 Issued Notice of Compliance 2016-11
210935 Antihemophilic factor (recombinant, B-domain deleted, pegylated) Antihemorrhagics 2017-12 Issued Notice of Compliance 2018-10
218531 Antihemophilic factor VIII (recombinant, B-domain truncated), pegylated Antihemorrhagics 2018-09 Issued Notice of Compliance 2019-07
211942 Apalutamide Endocrine therapy 2018-01 Issued Notice of Compliance 2018-07
217320 Apomorphine hydrochloride Anti-parkinson drugs 2018-08 Issued Notice of Compliance 2020-06
247924 Aprotinin Antihemorrhagics 2021-02 Cancelled by sponsor 2022-02
286599 Aripiprazole Psycholeptics 2024-07 Issued Notice of Compliance 2025-01
255700 Asciminib hydrochloride Antineoplastic agents 2021-08 Issued Notice of Compliance 2022-06
273065 Ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate Drugs for constipation 2023-07 Issued Notice of Compliance 2024-08
186992 Ataluren All other therapeutic products 2015-09 Cancelled by sponsor 2016-03
217349 Ataluren Other drugs for disorders of the musculo-skeletal system 2018-09 Cancelled by sponsor 2019-10
196843 Atezolizumab Antineoplastic agents 2016-08 Issued Notice of Compliance under the NOC/c Guidance 2017-04
253186 Atogepant Analgesics 2021-07 Issued Notice of Compliance 2022-12
262121 Atropine sulfate Ophthalmologicals 2023-04 Cancelled by sponsor 2024-07
248255 Avacopan Immunosuppressants 2021-05 Issued Notice of Compliance 2022-04
245680 Avalglucosidase alfa Other alimentary tract and metabolism products 2020-11 Issued Notice of Compliance 2021-11
220887 Avanafil Urologicals 2019-06 Issued Notice of Deficiency - Withdrawal 2021-10
278913 Avapritinib Antineoplastic agents 2023-11 Issued Notice of Compliance 2024-09
251688 Avatrombopag maleate Antihemorrhagics 2021-06 Issued Notice of Compliance 2023-11
204052 Avelumab Antineoplastic agents 2017-04 Issued Notice of Compliance under the NOC/c Guidance 2017-12
208742 Avelumab Antineoplastic agents 2017-09 Issued Notice of Compliance under the NOC/c Guidance 2018-05
218389 Axicabtagene ciloleucel Antineoplastic agents 2018-08 Issued Notice of Compliance 2019-02
240668 Azacitidine Antineoplastic agents 2020-07 Issued Notice of Compliance 2021-01
221579 Bacillus Calmette-Guerin BCG - Strain Russian BCG-I Immunostimulants 2018-12 Issued Notice of Compliance under the NOC/c Guidance 2020-12
227361 Baloxavir marboxil Antivirals for systemic use 2019-05 Issued Notice of Compliance 2020-02
193687 Bamlanivimab *For use in relation to COVID-19 Antiinflammatory and antirheumatic products 2016-05 Issued Notice of Compliance 2018-08
244947 Bamlanivimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2020-10 Authorized under Interim Order 2020-11
253646 Bamlanivimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-07 Cancelled by sponsor 2023-02
208886 Belinostat Antineoplastic agents 2017-12 Cancelled by sponsor 2019-11
245791 Belumosudil mesylate Immunosuppressants 2021-01 Issued Notice of Compliance 2022-03
254495 Belzutifan Antineoplastic agents 2021-09 Issued Notice of Compliance 2022-07
248962 Bendamustine hydrochloride Antineoplastic agents 2021-03 Issued Notice of Compliance 2022-01
249957 Bendamustine hydrochloride Antineoplastic agents 2021-07 Issued Notice of Compliance 2022-05
204008 Benralizumab Immunosuppressants 2017-04 Issued Notice of Compliance 2018-02
179294 Bepotastine besilate Ophthalmologicals 2015-10 Issued Notice of Compliance 2016-07
252301 Berotralstat hydrochloride Other hematological agents 2021-08 Issued Notice of Compliance 2022-06
203765 Betamethasone valerate, fusidic acid Corticosteroids, dermatological preparations 2017-06 Issued Notice of Compliance 2018-04
227270 Betula verrucosa extract Nasal preparations 2019-06 Issued Notice of Compliance 2020-04
201427 Bevacizumab Antineoplastic agents 2017-02 Issued Notice of Compliance 2018-04
218183 Bevacizumab Antineoplastic agents 2018-08 Issued Notice of Compliance 2019-06
217524 Bevacizumab Antineoplastic agents 2018-08 Issued Notice of Compliance 2021-01
244450 Bevacizumab Antineoplastic agents 2020-11 Issued Notice of Compliance 2021-09
242395 Bevacizumab Antineoplastic agents 2020-10 Cancelled by sponsor 2021-09
237499 Bevacizumab Antineoplastic agents 2020-07 Issued Notice of Compliance 2021-11
247724 Bevacizumab Antineoplastic agents 2021-02 Issued Notice of Compliance 2021-11
247369 Bevacizumab Antineoplastic agents 2021-02 Issued Notice of Compliance 2021-11
258973 Bevacizumab Antineoplastic agents 2022-03 Issued Notice of Compliance 2023-01
203718 Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 2017-09 Issued Notice of Compliance 2018-07
184231 Bilastine Antihistamines for systemic use 2015-06 Issued Notice of Compliance 2016-04
259843 Bimatoprost Ophthalmologicals 2022-02 Issued Notice of Compliance 2022-12
238499 Bimekizumab Immunosuppressants 2021-04 Issued Notice of Compliance 2022-02
237410 Binimetinib Antineoplastic agents 2020-05 Issued Notice of Compliance 2021-03
203050 Bisoprolol fumarate Beta blocking agents 2017-07 Issued Notice of Compliance 2019-11
231842 Bisoprolol fumarate Beta blocking agents 2020-05 Cancelled by sponsor 2020-09
232423 Bivalirudin Antithrombotic agents 2019-11 Issued Notice of Compliance 2020-09
181723 Blinatumomab Antineoplastic agents 2015-04 Issued Notice of Compliance under the NOC/c Guidance 2015-12
273611 Bortezomib Antineoplastic agents 2023-07 Issued Notice of Compliance 2024-07
190645 Botulinum antitoxin, serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins 2016-02 Issued Notice of Compliance 2016-12
192684 Brexpiprazole Psycholeptics 2016-04 Issued Notice of Compliance 2017-02
246355 Brexucabtagene autoleucel Antineoplastic agents 2020-12 Issued Notice of Compliance 2021-06
210369 Brigatinib Antineoplastic agents 2017-11 Issued Notice of Compliance under the NOC/c Guidance 2018-07
232449 Brilliant blue G Ophthalmologicals 2020-03 Issued Notice of Compliance 2021-01
262030 Brincidofovir Antivirals for systemic use 2022-05 Issued Notice of Compliance 2023-12
183355 Brivaracetam Antiepileptics 2015-05 Issued Notice of Compliance 2016-03
195317 Brodalumab Immunosuppressants 2016-07 Issued Notice of Compliance 2018-03
226224 Brolucizumab Ophthalmologicals 2019-05 Issued Notice of Compliance 2020-03
227232 Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2019-05 Issued Notice of Compliance 2019-11
220876 Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2019-06 Issued Notice of Compliance 2020-04
242357 Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 2020-09 Issued Notice of Compliance 2021-07
231224 Bupivacaine Anesthetics 2019-12 Cancelled by sponsor 2021-08
233561 Bupivacaine, meloxicam Antiinflammatory and antirheumatic products 2020-01 Issued Notice of Compliance 2022-03
215660 Buprenorphine Other nervous system drugs 2018-05 Issued Notice of Compliance 2018-11
196428 Buprenorphine hydrochloride Other nervous system drugs 2016-08 Issued Notice of Compliance 2017-06
204746 Buprenorphine hydrochloride Other nervous system drugs 2017-06 Issued Notice of Compliance 2018-04
202774 Bupropion hydrochloride, naltrexone hydrochloride Antiobesity preparations, excluding diet products 2017-04 Issued Notice of Compliance 2018-02
216239 Burosumab Drugs for treatment of bone diseases 2018-06 Issued Notice of Compliance 2018-12
198308 C1 esterase inhibitor (human) Other hematological agents 2016-11 Issued Notice of Compliance 2017-09
280033 Cabotegravir, cabotegravir sodium Antivirals for systemic use 2023-11 Issued Notice of Compliance 2024-05
227315 Cabotegravir, rilpivirine Antivirals for systemic use 2019-05 Issued Notice of Compliance 2020-03
206230 Cabozantinib Antineoplastic agents 2017-07 Issued Notice of Compliance 2018-09
225810 Caffeine citrate Psychoanaleptics 2019-05 Issued Notice of Compliance 2020-03
268282 Calaspargase pegol Antineoplastic agents 2022-11 Issued Notice of Compliance 2023-11
205392 Calcifediol Vitamins 2017-09 Issued Notice of Compliance 2018-07
262870 Calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate Other nervous system drugs 2022-07 Issued Notice of Compliance 2023-05
213303 Canakinumab Immunosuppressants 2018-06 Cancelled by sponsor 2018-12
255032 Cangrelor tetrasodium Antithrombotic agents 2021-11 Issued Notice of Compliance 2023-01
268559 Cannabidiol Antiepileptics 2023-01 Issued Notice of Compliance 2023-11
274859 Capivasertib Antineoplastic agents 2023-06 Issued Notice of Compliance 2024-01
230001 Caplacizumab Antithrombotic agents 2019-08 Issued Notice of Compliance 2020-02
255972 Capmatinib dihydrochloride Antineoplastic agents 2021-09 Issued Notice of Compliance under the NOC/c Guidance 2022-05
248574 Captopril Agents acting on the renin-angiotensin system 2021-04 Issued Notice of Compliance 2023-12
257242 Carbidopa, levodopa Anti-parkinson drugs 2022-04 Issued Notice of Compliance 2022-10
184479 Carfilzomib Antineoplastic agents 2015-07 Issued Notice of Compliance 2016-01
249774 Cariprazine hydrochloride Psycholeptics 2021-06 Issued Notice of Compliance 2022-04
249830 Casirivimab, imdevimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-02 Authorized under Interim Order 2021-06
256264 Casirivimab, imdevimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-09 Cancelled by sponsor 2024-06
234610 Cedazuridine, decitabine Antineoplastic agents 2020-01 Issued Notice of Compliance 2020-07
261973 Cefditoren pivoxil Antibacterials for systemic use 2022-07 Cancelled by sponsor 2024-03
189720 Cefixime Antibacterials for systemic use 2016-05 Issued Notice of Compliance 2017-10
218718 Cemiplimab Antineoplastic agents 2018-08 Issued Notice of Compliance under the NOC/c Guidance 2019-04
218145 Cenegermin Ophthalmologicals 2018-08 Issued Notice of Compliance 2019-02
261689 Cenobamate Antiepileptics 2022-07 Issued Notice of Compliance 2023-06
216539 Cerliponase alfa Other alimentary tract and metabolism products 2018-06 Issued Notice of Compliance 2018-12
240337 Cevimeline hydrochloride Other nervous system drugs 2020-09 Issued Notice of Non-compliance - Withdrawal 2022-04
244627 ChAdOx1-S (recombinant) *For use in relation to COVID-19 Vaccines 2020-10 Authorized under Interim Order 2021-02
248651 ChAdOx1-S (recombinant) *For use in relation to COVID-19 Vaccines 2021-01 Authorized under Interim Order 2021-02
253700 ChAdOx1-S (recombinant) *For use in relation to COVID-19 Vaccines   Issued Notice of Compliance 2021-11
275762 Chikungunya virus live-attenuated Vaccines 2023-08 Issued Notice of Compliance 2024-06
238994 Chlormethine Antineoplastic agents 2020-08 Issued Notice of Compliance 2021-06
270862 Chloroprocaine hydrochloride Anesthetics 2023-05 Issued Notice of Compliance 2024-08
223801 Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride Blood substitutes and perfusion solutions 2019-06 Issued Notice of Compliance 2020-04
200865 Cidofovir Antivirals for systemic use 2017-04 Issued Notice of Compliance 2018-03
258295 Cilgavimab, tixagevimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-11 Issued Notice of Compliance 2022-04
240368 Cilostazol Antithrombotic agents 2021-02 Cancelled by sponsor 2022-07
262122 Ciltacabtagene autoleucel Antineoplastic agents 2022-04 Issued Notice of Compliance under the NOC/c Guidance 2023-02
195151 Cinnarizine, dimenhydrinate Other nervous system drugs 2016-09 Issued Notice of Non-compliance - Withdrawal 2018-11
200943 Cladribine Immunosuppressants 2017-02 Issued Notice of Compliance 2017-11
265619 Clascoterone Anti-acne preparations 2022-08 Issued Notice of Compliance 2023-06
193638 Clozapine Psycholeptics 2016-05 Issued Notice of Compliance 2016-11
201114 Coagulation factor IX (recombinant), pegylated Antihemorrhagics 2017-02 Issued Notice of Compliance 2017-11
199705 Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 2017-05 Issued Notice of Compliance 2018-03
182788 Cobimetinib fumarate Antineoplastic agents 2015-04 Issued Notice of Compliance 2016-02
248423 Colchicine Antigout preparations 2021-02 Issued Notice of Compliance 2021-08
248711 Colchicine *For use in relation to COVID-19 Antigout preparations 2021-01 Cancelled by sponsor 2021-06
267120 Concizumab Antihemorrhagics 2022-09 Issued Notice of Compliance 2023-03
267314 Concizumab Antihemorrhagics 2022-09 Issued Notice of Compliance 2023-07
255077 Copanlisib dihydrochloride Antineoplastic agents 2021-08 Cancelled by sponsor 2021-12
246125 Copper, manganese sulfate, selenious acid, sodium iodide, zinc sulfate Blood substitutes and perfusion solutions 2021-03 Issued Notice of Compliance 2023-03
253111 Corynebacterium diphtheria 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 2021-07 Issued Notice of Compliance 2022-05
247042 Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F Vaccines 2021-01 Issued Notice of Compliance 2021-11
281914 Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B Vaccines 2024-01 Issued Notice of Compliance 2024-07
206906 Crisaborole Other dermatological preparations 2017-08 Issued Notice of Compliance 2018-06
257092 Crisantaspase, recombinant Antineoplastic agents 2021-11 Issued Notice of Compliance 2022-09
194580 Cyclosporine Ophthalmologicals 2016-08 Issued Notice of Non-compliance - Withdrawal 2018-04
215813 Cyclosporine Ophthalmologicals 2018-07 Issued Notice of Compliance 2018-12
234677 Cyclosporine Ophthalmologicals 2020-04 Issued Notice of Compliance 2021-02
211635 Cysteamine hydrochloride Ophthalmologicals 2018-02 Issued Notice of Compliance 2019-02
242743 Cytarabine, daunorubicin Antineoplastic agents 2020-11 Issued Notice of Compliance 2021-04
190458 Daclizumab Immunosuppressants 2016-02 Issued Notice of Compliance 2016-12
214572 Dacomitinib Antineoplastic agents 2018-05 Issued Notice of Compliance 2019-02
212390 Dalbavancin Antibacterials for systemic use 2018-03 Issued Notice of Compliance 2018-09
274338 Danicopan Other hematological agents 2023-09 Issued Notice of Compliance 2024-07
263001 Daprodustat Antianemic preparations 2022-05 Cancelled by sponsor 2023-07
187648 Daratumumab Antineoplastic agents 2015-11 Issued Notice of Compliance under the NOC/c Guidance 2016-06
255507 Daridorexant hydrochloride Other nervous system drugs 2021-10 Issued Notice of Compliance 2023-04
226146 Darolutamide Endocrine therapy 2019-04 Issued Notice of Compliance 2020-02
217347 Darvadstrocel Unassigned 2018-08 Cancelled by sponsor 2019-06
284807 Datopotamab deruxtecan Antineoplastic agents 2024-07 Cancelled by sponsor 2025-03
267589 Davesomeran, elasomeran *For use in relation to COVID-19 Vaccines 2022-09 Issued Notice of Compliance 2022-11
207372 Decitabine Antineoplastic agents 2018-03 Issued Notice of Compliance 2019-01
217663 Decitabine Antineoplastic agents 2018-09 Issued Notice of Compliance 2019-07
200808 Defibrotide Antithrombotic agents 2017-01 Issued Notice of Compliance 2017-07
284667 Delafloxacin meglumine Antibacterials for systemic use 2024-06 Issued Notice of Compliance 2025-01
271806 Denosumab Drugs for treatment of bone diseases 2023-03 Issued Notice of Compliance 2024-02
267788 Denosumab Drugs for treatment of bone diseases 2023-03 Issued Notice of Compliance 2024-03
227886 Dequalinium chloride Gynecological antiinfectives and antiseptics 2019-07 Issued Notice of Compliance 2021-07
195186 Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 2016-07 Issued Notice of Compliance 2017-05
208152 Dermatophagoides farinae, dermatophagoides pteronyssinus Allergens 2017-09 Cancelled by sponsor 2020-07
199626 Desvenlafaxine Psychoanaleptics 2017-02 Issued Notice of Compliance 2017-08
259397 Deucravacitinib Immunosuppressants 2022-01 Issued Notice of Compliance 2022-11
212391 Dexamethasone sodium phosphate, netilmicin sulfate Ophthalmologicals 2018-02 Issued Notice of Compliance 2019-10
258157 Dexamethasone, levofloxacin Ophthalmologicals 2021-12 Issued Notice of Compliance 2023-12
254850 Diamorphine hydrochloride Other nervous system drugs 2021-08 Issued Notice of Compliance 2022-02
254548 Difelikefalin All other therapeutic products 2021-10 Issued Notice of Compliance 2022-08
212066 Dinutuximab Antineoplastic agents 2018-02 Issued Notice of Compliance 2018-11
240071 Diroximel fumarate Immunosuppressants 2020-07 Cancelled by sponsor 2023-02
220402 Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic All other non-therapeutic products 2018-11 Issued Notice of Compliance 2019-09
206402 Dolutegravir sodium, rilpivirine hydrochloride Antivirals for systemic use 2017-07 Issued Notice of Compliance 2018-05
220275 Dolutegravir, lamivudine Antivirals for systemic use 2018-10 Issued Notice of Compliance 2019-08
211293 Doravirine Antivirals for systemic use 2017-12 Issued Notice of Compliance 2018-10
211708 Doravirine, lamivudine, tenofovir disoproxil fumarate Antivirals for systemic use 2018-01 Issued Notice of Compliance 2018-11
251105 Dostarlimab Antineoplastic agents 2021-04 Issued Notice of Compliance under the NOC/c Guidance 2021-12
218346 Dotatate Diagnostic radiopharmaceuticals 2018-09 Issued Notice of Compliance 2019-07
240372 Dronabinol Antiemetics and antinauseants 2021-05 Cancelled by sponsor 2023-05
242176 Drospirenone Sex hormones and modulators of the genital system 2021-02 Issued Notice of Compliance 2021-11
236197 Drospirenone, estetrol monohydrate Sex hormones and modulators of the genital system 2020-05 Issued Notice of Compliance 2021-03
201285 Dupilumab Immunosuppressants 2017-02 Issued Notice of Compliance 2017-11
202953 Durvalumab Antineoplastic agents 2017-03 Issued Notice of Compliance under the NOC/c Guidance 2017-11
208834 Durvalumab Antineoplastic agents 2017-09 Issued Notice of Compliance under the NOC/c Guidance 2018-05
256568 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live, attenuated) Vaccines 2021-10 Issued Notice of Compliance 2022-11
214391 Edaravone Other nervous system drugs 2018-04 Issued Notice of Compliance 2018-10
187363 Edoxaban Antithrombotic agents 2015-12 Issued Notice of Compliance 2016-11
283753 Efanesoctocog alfa Antihemorrhagics 2024-05 Issued Notice of Compliance 2025-03
267438 Efgartigimod alfa Immunosuppressants 2022-11 Issued Notice of Compliance 2023-09
209513 Elagolix Sex hormones and modulators of the genital system 2017-12 Issued Notice of Compliance 2018-10
244946 Elasomeran *For use in relation to COVID-19 Vaccines 2020-10 Authorized under Interim Order 2020-12
252733 Elasomeran *For use in relation to COVID-19 Vaccines   Issued Notice of Compliance 2021-09
265656 Elasomeran, imelasomeran *For use in relation to COVID-19 Vaccines 2022-06 Issued Notice of Compliance 2022-09
185866 Elbasvir, grazoprevir Antivirals for systemic use 2015-07 Issued Notice of Compliance 2016-01
246955 Elexacaftor, ivacaftor, tezacaftor Other respiratory system products 2020-12 Issued Notice of Compliance 2021-06
183050 Eliglustat tartrate Other alimentary tract and metabolism products 2015-05 Issued Notice of Compliance 2017-04
188144 Elotuzumab Antineoplastic agents 2015-12 Issued Notice of Compliance 2016-06
273519 Elranatamab Antineoplastic agents 2023-04 Issued Notice of Compliance under the NOC/c Guidance 2023-12
190162 Eluxadoline Drugs for functional gastrointestinal disorders 2016-04 Issued Notice of Compliance 2017-01
237121 Emapalumab Immunosuppressants 2020-05 Cancelled by sponsor 2021-01
212635 Emicizumab Antihemorrhagics 2018-02 Issued Notice of Compliance 2018-08
217033 Enasidenib mesylate Antineoplastic agents 2018-07 Issued Notice of Compliance under the NOC/c Guidance 2019-02
237413 Encorafenib Antineoplastic agents 2020-05 Issued Notice of Compliance 2021-03
238571 Encorafenib Antineoplastic agents 2020-06 Issued Notice of Compliance 2021-03
251438 Enfortumab vedotin Antineoplastic agents 2021-05 Issued Notice of Compliance 2021-10
233058 Enoxaparin sodium Antithrombotic agents 2019-12 Issued Notice of Compliance 2020-10
233987 Enoxaparin sodium Antithrombotic agents 2020-01 Issued Notice of Compliance 2020-11
231767 Enoxaparin sodium Antithrombotic agents 2019-11 Issued Notice of Compliance 2020-12
243026 Enoxaparin sodium Antithrombotic agents 2021-12 Issued Notice of Compliance 2022-10
266545 Enoxaparin sodium Antithrombotic agents 2022-09 Issued Notice of Compliance 2023-07
262815 Enterococcus faecalis inactivated, Escherichia coli inactivated, Klebsiella pneumoniae inactivated, Proteus vulgaris inactivated Vaccines 2022-05 Cancelled by sponsor 2023-05
227517 Entrectinib Antineoplastic agents 2019-06 Issued Notice of Compliance under the NOC/c Guidance 2020-02
228159 Entrectinib Antineoplastic agents 2019-07 Issued Notice of Compliance 2020-05
271331 Epcoritamab Antineoplastic agents 2023-02 Issued Notice of Compliance under the NOC/c Guidance 2023-10
274598 Eplontersen Other nervous system drugs 2023-08 Issued Notice of Compliance 2024-06
233288 Eptinezumab Analgesics 2020-03 Issued Notice of Compliance 2021-01
224529 Erdafitinib Antineoplastic agents 2019-03 Issued Notice of Compliance under the NOC/c Guidance 2019-10
208607 Erenumab Analgesics 2017-10 Issued Notice of Compliance 2018-08
204724 Ertugliflozin pidolate Drugs used in diabetes 2017-07 Issued Notice of Compliance 2018-05
201005 Ertugliflozin pidolate, metformin hydrochloride Drugs used in diabetes 2017-08 Issued Notice of Compliance 2018-05
201006 Ertugliflozin pidolate, sitagliptin phosphate monohydrate Drugs used in diabetes 2017-07 Issued Notice of Compliance 2018-05
255132 Erwinia L-asparaginase Antineoplastic agents 2021-09 Cancelled by sponsor 2023-07
222855 Esketamine hydrochloride Psychoanaleptics 2019-01 Issued Notice of Compliance 2020-05
223938 Estradiol hemihydrate Sex hormones and modulators of the genital system 2019-10 Issued Notice of Compliance 2020-08
224010 Estradiol hemihydrate, progesterone Sex hormones and modulators of the genital system 2019-11 Issued Notice of Compliance 2020-09
267148 Estradiol, norethindrone acetate, relugolix Pituitary and hypothalamic hormones and analogues 2022-11 Issued Notice of Compliance 2023-09
268111 Estradiol, norethindrone acetate, relugolix Pituitary and hypothalamic hormones and analogues 2022-12 Issued Notice of Compliance 2023-10
203472 Estriol, lactobacillus acidophilus Sex hormones and modulators of the genital system 2017-06 Issued Notice of Deficiency - Withdrawal 2019-01
193864 Etanercept Immunosuppressants 2016-06 Issued Notice of Compliance 2017-04
234562 Etanercept Immunosuppressants 2020-02 Issued Notice of Compliance 2022-08
256653 Etesevimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-09 Cancelled by sponsor 2023-02
279315 Ethinyl estradiol, segesterone acetate Sex hormones and modulators of the genital system 2023-11 Issued Notice of Compliance 2024-12
231245 Etomidate Anesthetics 2019-12 Issued Notice of Compliance 2020-07
226314 Etonogestrel Sex hormones and modulators of the genital system 2019-05 Issued Notice of Compliance 2020-05
273721 Etranacogene dezaparvovec Other hematological agents 2023-04 Issued Notice of Compliance 2023-10
271038 Etrasimod L-arginine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2023-03 Issued Notice of Compliance 2024-01
272688 Evinacumab Lipid modifying agents 2023-03 Issued Notice of Compliance 2023-09
284351 Exagamglogene autotemcel Other hematological agents 2024-03 Issued Notice of Compliance 2024-09
267502 Famtozinameran, tozinameran *For use in relation to COVID-19 Vaccines 2022-09 Issued Notice of Compliance 2022-10
253904 Faricimab Ophthalmologicals 2021-08 Issued Notice of Compliance 2022-05
256417 Favipiravir *For use in relation to COVID-19 Antivirals for systemic use 2021-09 Cancelled by sponsor 2022-02
285129 Fecal microbiota Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2024-05 Issued Notice of Compliance 2025-03
229866 Fedratinib dihydrochloride monohydrate Antineoplastic agents 2019-10 Issued Notice of Compliance 2020-07
272960 Ferric carboxymaltose Antianemic preparations 2023-04 Issued Notice of Compliance 2024-03
260666 Ferric maltol Antianemic preparations 2022-06 Issued Notice of Compliance 2024-08
239850 Ferric pyrophosphate citrate Antianemic preparations 2020-06 Issued Notice of Compliance 2021-04
258248 Ferumoxytol Antianemic preparations 2022-03 Cancelled by sponsor 2023-02
280470 Fezolinetant Other gynecologicals 2024-01 Issued Notice of Compliance 2024-12
195870 Fibrinogen (human) Antihemorrhagics 2016-08 Issued Notice of Compliance 2017-06
239016 Fibrinogen (human), thrombin (human) Antihemorrhagics 2020-05 Issued Notice of Compliance 2021-03
275853 Fidanacogene elaparvovec Antihemorrhagics 2023-06 Issued Notice of Compliance 2023-12
235219 Filgotinib Immunosuppressants 2020-04 Cancelled by sponsor 2021-01
212016 Filgrastim (r-metHuG-CSF) Immunostimulants 2018-02 Cancelled by sponsor 2019-08
214080 Filgrastim (r-metHuG-CSF) Immunostimulants 2018-04 Issued Notice of Compliance 2020-04
220512 Filgrastim (r-metHuG-CSF) Immunostimulants 2019-03 Issued Notice of Compliance 2021-10
267597 Filgrastim (r-metHuG-CSF) Immunostimulants 2023-01 Cancelled by sponsor 2024-07
273870 Filgrastim (r-metHuG-CSF) Immunostimulants 2024-05 Issued Notice of Compliance 2025-03
249486 Finerenone Diuretics 2021-04 Cancelled by sponsor 2021-10
258231 Finerenone Diuretics 2021-12 Issued Notice of Compliance 2022-10
189352 Flibanserin Other gynecologicals 2016-04 Issued Notice of Compliance 2018-02
193105 Florbetaben (18F) Diagnostic radiopharmaceuticals 2016-04 Issued Notice of Compliance 2017-02
201510 Fluocinolone acetonide Ophthalmologicals 2017-02 Issued Notice of Compliance 2018-11
211768 Fluorouracil Antineoplastic agents 2018-04 Issued Notice of Compliance 2019-02
198520 Fluoxetine hydrochloride Psychoanaleptics 2016-12 Issued Notice of Compliance 2017-06
204880 Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 2017-06 Issued Notice of Compliance 2018-04
197873 Fluticasone propionate Drugs for obstructive airway diseases 2016-10 Issued Notice of Compliance 2017-08
197974 Fluticasone propionate, salmeterol xinafoate Drugs for obstructive airway diseases 2016-11 Issued Notice of Compliance 2018-04
188743 Follitropin delta Sex hormones and modulators of the genital system 2016-01 Issued Notice of Compliance 2018-03
201306 Formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 2017-02 Issued Notice of Compliance 2018-03
263826 Foscarbidopa, foslevodopa Anti-parkinson drugs 2022-07 Issued Notice of Compliance 2023-05
233046 Foscarnet sodium Antivirals for systemic use 2019-12 Issued Notice of Compliance 2020-10
219662 Fosfomycin sodium Antibacterials for systemic use 2018-11 Issued Notice of Compliance 2019-05
232078 Fostamatinib disodium Antihemorrhagics 2020-01 Issued Notice of Compliance 2020-11
250213 Fostemsavir tromethamine Antivirals for systemic use 2021-04 Issued Notice of Compliance 2021-10
226828 Fremanezumab Analgesics 2019-06 Issued Notice of Compliance 2020-04
275803 Fruquintinib Antineoplastic agents 2023-11 Issued Notice of Compliance 2024-09
186333 Gadoteric acid Contrast media 2015-12 Issued Notice of Compliance 2016-11
219521 Galcanezumab Analgesics 2018-10 Issued Notice of Compliance 2019-07
221824 Gallium (68Ga) chloride Diagnostic radiopharmaceuticals 2019-04 Issued Notice of Compliance 2019-11
227804 Gallium (68Ga) chloride, germanium (68Ge) chloride Diagnostic radiopharmaceuticals 2019-10 Issued Notice of Compliance 2020-08
242332 Gallium (68Ga) gozetotide Diagnostic radiopharmaceuticals 2021-02 Issued Notice of Compliance 2022-10
263638 Gallium (68Ga) gozetotide Diagnostic radiopharmaceuticals 2022-06 Issued Notice of Compliance 2023-04
248874 Gallium oxodotreotide Diagnostic radiopharmaceuticals 2021-05 Issued Notice of Compliance 2022-02
221456 Ganciclovir Ophthalmologicals 2019-02 Issued Notice of Compliance 2022-09
255697 Gefapixant Cough and cold preparations 2021-12 Cancelled by sponsor 2024-06
223091 Gemtuzumab ozogamicin Antineoplastic agents 2019-02 Issued Notice of Compliance 2019-11
227918 Gilteritinib fumarate Antineoplastic agents 2019-06 Issued Notice of Compliance 2019-12
237194 Givosiran Bile and liver therapy 2020-04 Issued Notice of Compliance 2020-10
225793 Glasdegib Antineoplastic agents 2019-07 Issued Notice of Compliance 2020-04
202233 Glecaprevir, pibrentasvir Antivirals for systemic use 2017-02 Issued Notice of Compliance 2017-08
265517 Glofitamab Antineoplastic agents 2022-07 Issued Notice of Compliance under the NOC/c Guidance 2023-03
220839 Glucagon Pancreatic hormones 2018-11 Issued Notice of Compliance 2019-09
231585 Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine Blood substitutes and perfusion solutions 2020-03 Issued Notice of Compliance 2020-12
197038 Glycopyrrolate Drugs for functional gastrointestinal disorders 2017-01 Issued Notice of Compliance 2017-10
228353 Glycopyrronium bromide, indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 2019-09 Issued Notice of Compliance 2020-07
232286 Goserelin acetate Endocrine therapy 2020-07 Cancelled by sponsor 2021-10
200590 Guselkumab Immunosuppressants 2017-01 Issued Notice of Compliance 2017-11
235556 Haemagglutinin, neuraminidase antigen Vaccines 2020-03 Issued Notice of Compliance 2021-01
289304 Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain A(Yam) Vaccines 2024-09 Issued Notice of Compliance 2024-12
200726 Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B Vaccines 2017-05 Issued Notice of Compliance 2019-03
203436 Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 2017-04 Issued Notice of Compliance 2018-02
222669 Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 2019-01 Issued Notice of Compliance 2019-11
234113 Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) Vaccines 2020-01 Cancelled by sponsor 2020-11
212718 Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations 2018-05 Issued Notice of Compliance 2020-06
212276 Hemin Other alimentary tract and metabolism products 2018-01 Issued Notice of Compliance 2018-07
259302 Hepatitis B surface antigen (recombinant) Vaccines 2022-02 Issued Notice of Compliance 2022-12
205160 Human heterologous liver cells Other alimentary tract and metabolism products 2017-06 Cancelled by sponsor 2018-07
251360 Human insulin (recombinant) Drugs used in diabetes 2021-05 Issued Notice of Compliance 2022-08
247727 Hyaluronidase (human recombinant), immunoglobulin (human) Immune sera and immunoglobulins 2021-02 Issued Notice of Compliance 2022-01
212396 Hydrochlorothiazide, zofenopril calcium Agents acting on the renin-angiotensin system 2018-06 Cancelled by sponsor 2019-06
216854 Hydrogen peroxide Other dermatological preparations 2018-12 Cancelled by sponsor 2019-08
227235 Icosapent ethyl Lipid modifying agents 2019-07 Issued Notice of Compliance 2019-12
182503 Idarucizumab All other therapeutic products 2015-05 Issued Notice of Compliance under the NOC/c Guidance 2016-04
244266 Idecabtagene vicleucel Antineoplastic agents 2020-10 Issued Notice of Compliance under the NOC/c Guidance 2021-05
194291 Immunoglobulin (human) Immune sera and immunoglobulins 2016-10 Issued Notice of Compliance 2017-08
226576 Immunoglobulin (human) Immune sera and immunoglobulins 2019-06 Issued Notice of Compliance 2019-12
202924 Immunoglobulin g (human) Immune sera and immunoglobulins 2017-04 Issued Notice of Compliance 2018-02
288071 Inavolisib Antineoplastic agents 2024-08 Issued Notice of Compliance 2025-02
243470 Inclisiran sodium Lipid modifying agents 2020-09 Issued Notice of Compliance 2021-07
227987 Indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 2019-07 Issued Notice of Compliance 2020-05
271065 Inebilizumab Immunosuppressants 2023-02 Issued Notice of Compliance 2023-12
246904 Infigratinib phosphate Antineoplastic agents 2021-01 Issued Notice of Compliance under the NOC/c Guidance 2021-09
226189 Infliximab Immunosuppressants 2019-05 Issued Notice of Compliance 2020-03
248134 Infliximab Immunosuppressants 2021-02 Issued Notice of Compliance 2021-12
267444 Influenza virus type A (H1N1) Vaccines 2022-10 Issued Notice of Compliance 2023-10
214274 Inotersen sodium Other nervous system drugs 2018-04 Issued Notice of Compliance 2018-10
204077 Inotuzumab ozogamicin Antineoplastic agents 2017-05 Issued Notice of Compliance 2018-03
226573 Insulin aspart Drugs used in diabetes 2019-12 Issued Notice of Compliance 2020-10
243229 Insulin aspart Drugs used in diabetes 2020-12 Issued Notice of Compliance 2021-10
198124 Insulin degludec Drugs used in diabetes 2016-10 Issued Notice of Compliance 2017-08
194513 Insulin degludec, liraglutide Drugs used in diabetes 2017-06 Issued Notice of Compliance 2018-04
202772 Insulin glargine Drugs used in diabetes 2017-04 Cancelled by sponsor 2019-02
252068 Insulin glargine Drugs used in diabetes 2021-06 Issued Notice of Compliance 2022-04
207006 Insulin glargine, lixisenatide Drugs used in diabetes 2017-09 Issued Notice of Compliance 2018-07
273850 Insulin icodec Drugs used in diabetes 2023-05 Issued Notice of Compliance 2024-03
189076 Insulin injection human biosynthetic Drugs used in diabetes 2016-09 Issued Notice of Compliance 2017-07
200792 Insulin lispro Drugs used in diabetes 2017-01 Issued Notice of Compliance 2017-11
244611 Insulin lispro Drugs used in diabetes 2020-11 Issued Notice of Compliance 2021-09
196107 Iodine Contrast media 2016-09 Issued Notice of Compliance 2017-07
201481 Ioflupane (123I) Diagnostic radiopharmaceuticals 2017-02 Issued Notice of Compliance 2017-12
283206 Iptacopan hydrochloride Immunosuppressants 2024-03 Issued Notice of Compliance 2025-01
189897 Iron dextran Antianemic preparations 2016-05 Cancelled by sponsor 2017-06
193890 Iron isomaltoside 1000 Antianemic preparations 2016-07 Issued Notice of Compliance 2018-06
229245 Isatuximab Antineoplastic agents 2019-07 Issued Notice of Compliance 2020-04
208919 Isavuconazonium sulfate Antimycotics for systemic use 2018-02 Issued Notice of Compliance 2018-12
263460 Isotretinoin Anti-acne preparations 2022-08 Issued Notice of Compliance 2023-06
211292 Ivacaftor, tezacaftor Other respiratory system products 2017-12 Issued Notice of Compliance 2018-06
211000 Ivermectin Anthelmintics 2017-12 Issued Notice of Compliance 2018-09
277139 Ivosidenib Antineoplastic agents 2023-09 Issued Notice of Compliance 2024-07
190498 Ixazomib citrate Antineoplastic agents 2016-02 Issued Notice of Compliance 2016-08
184993 Ixekizumab Immunosuppressants 2015-07 Issued Notice of Compliance 2016-05
213920 Lanadelumab Other hematological agents 2018-03 Issued Notice of Compliance 2018-09
259953 Landiolol hydrochloride Beta blocking agents 2022-02 Issued Notice of Compliance 2023-11
219998 Larotrectinib Antineoplastic agents 2018-11 Issued Notice of Compliance under the NOC/c Guidance 2019-07
236369 Lasmiditan Analgesics 2020-04 Cancelled by sponsor 2021-01
211732 Latanoprostene bunod Ophthalmologicals 2018-03 Issued Notice of Compliance 2018-12
285014 Lazertinib mesylate monohydrate Antineoplastic agents 2024-04 Issued Notice of Compliance 2025-03
272660 Lebrikizumab Other dermatological preparations 2023-05 Issued Notice of Compliance 2024-06
233292 Lefamulin acetate Antibacterials for systemic use 2020-01 Issued Notice of Compliance 2020-07
231286 Lemborexant Psycholeptics 2020-01 Issued Notice of Compliance 2020-11
262999 Lenacapavir sodium Antivirals for systemic use 2022-05 Issued Notice of Compliance 2022-11
250805 Leronlimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-03 Interim Order expired 2021-09
204165 Letermovir Antivirals for systemic use 2017-05 Issued Notice of Compliance 2017-11
251157 LetibotulinumtoxinA Muscle relaxants 2021-08 Issued Notice of Compliance 2022-06
246800 Leuprolide mesylate Endocrine therapy 2021-01 Issued Notice of Compliance 2021-11
213656 Levetiracetam Antiepileptics 2018-09 Issued Notice of Compliance 2019-07
232047 Levothyroxine sodium Thyroid therapy 2020-01 Issued Notice of Compliance 2020-11
265823 Lidocaine hydrochloride, nifedipine Vasoprotectives 2022-11 Issued Notice of Compliance 2024-05
199810 Lifitegrast Ophthalmologicals 2016-12 Issued Notice of Compliance 2017-12
247562 Lisocabtagene maraleucel Antineoplastic agents 2021-02 Issued Notice of Compliance 2022-05
193862 Lixisenatide Drugs used in diabetes 2016-06 Issued Notice of Compliance 2017-05
284436 Loncastuximab tesirine Antineoplastic agents 2024-06 Issued Notice of Compliance under the NOC/c Guidance 2025-03
190891 Lonoctocog alfa Antihemorrhagics 2016-02 Issued Notice of Compliance 2016-12
198689 Lorcaserin hydrochloride Antiobesity preparations, excluding diet products 2016-11 Cancelled by sponsor 2018-02
215733 Lorlatinib Antineoplastic agents 2018-06 Issued Notice of Compliance under the NOC/c Guidance 2019-02
254883 Lumasiran Other alimentary tract and metabolism products 2021-08 Issued Notice of Compliance 2022-03
247485 Lurbinectedin Antineoplastic agents 2021-01 Issued Notice of Compliance under the NOC/c Guidance 2021-09
236441 Luspatercept Antianemic preparations 2020-03 Issued Notice of Compliance 2020-09
236625 Luspatercept Antianemic preparations 2020-04 Issued Notice of Compliance 2021-02
217184 Lutetium (177Lu) oxodotretotide Therapeutic radiopharmaceuticals 2018-07 Issued Notice of Compliance 2019-01
260951 Lutetium (177Lu) vipivotide tetraxetan Therapeutic radiopharmaceuticals 2022-02 Issued Notice of Compliance 2022-08
245848 Macitentan, tadalafil Antihypertensives 2020-12 Issued Notice of Compliance 2021-10
217446 Mannitol Diagnostic agents 2018-08 Issued Notice of Compliance 2019-06
271030 Maralixibat chloride Bile and liver therapy 2023-01 Issued Notice of Compliance 2023-07
259676 Maribavir Antivirals for systemic use 2022-03 Issued Notice of Compliance 2022-09
280462 Marstacimab Antihemorrhagics 2023-12 Cancelled by sponsor 2024-10
263505 Masitinib mesylate Antineoplastic agents 2022-05 Issued Notice of Deficiency - Withdrawal 2024-02
258772 Mavacamten Cardiac therapy 2022-01 Issued Notice of Compliance 2022-11
235023 Mecasermin Pituitary and hypothalamic hormones and analogues 2020-02 Issued Notice of Compliance 2020-12
233632 Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate Vaccines 2020-01 Issued Notice of Compliance 2020-10
191347 Mercaptamine bitartrate Other alimentary tract and metabolism products 2016-03 Issued Notice of Compliance 2017-06
266553 Meropenem trihydrate Antibacterials for systemic use 2023-03 Issued Notice of Compliance 2024-01
280730 Meropenem trihydrate, vaborbactam Antibacterials for systemic use 2024-01 Issued Notice of Compliance 2024-12
204605 Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2017-05 Issued Notice of Compliance 2018-03
198475 Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2017-02 Cancelled by sponsor 2020-08
194646 Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2016-09 Issued Notice of Compliance 2021-05
247241 Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2021-03 Issued Notice of Compliance 2022-01
263913 Metformin hydrochloride Drugs used in diabetes 2022-07 Issued Notice of Compliance 2023-01
262108 Methotrexate Immunosuppressants 2022-05 Issued Notice of Compliance 2024-03
254599 Methotrexate sodium Immunosuppressants 2021-11 Issued Notice of Compliance 2022-09
204879 Methoxyflurane Analgesics 2017-06 Issued Notice of Compliance 2018-04
219788 Methylene blue Diagnostic agents 2018-10 Issued Notice of Non-compliance - Withdrawal 2021-05
243224 Methylphenidate hydrochloride Psychoanaleptics 2021-01 Issued Notice of Compliance 2023-09
281510 Methylphenidate hydrochloride Psychoanaleptics 2024-01 Issued Notice of Compliance 2024-11
273908 Metreleptin Other alimentary tract and metabolism products 2023-04 Issued Notice of Compliance 2024-01
201101 Midostaurin Antineoplastic agents 2017-01 Issued Notice of Compliance 2017-07
196956 Migalastat hydrochloride Other alimentary tract and metabolism products 2016-11 Issued Notice of Compliance 2017-09
266471 Mirikizumab Immunosuppressants 2022-09 Issued Notice of Compliance 2023-07
251277 Mogamulizumab Antineoplastic agents 2021-05 Issued Notice of Compliance 2022-06
255584 Molnupiravir *For use in relation to COVID-19 Antivirals for systemic use 2021-08 Cancelled by sponsor 2023-04
281695 Momelotinib dihydrochloride monohydrate Antineoplastic agents 2024-01 Issued Notice of Compliance 2024-11
199704 Mometasone furoate Corticosteroids, dermatological preparations 2017-09 Cancelled by sponsor 2019-10
238027 Mometasone furoate monohydrate, olopatadine hydrochloride Nasal preparations 2020-07 Issued Notice of Compliance 2022-09
193199 Naloxone hydrochloride All other therapeutic products 2016-04 Issued Notice of Compliance 2016-10
211970 Naloxone hydrochloride dihydrate All other therapeutic products 2018-01 Cancelled by sponsor 2019-06
281754 Naloxone hydrochloride dihydrate All other therapeutic products 2024-04 Issued Notice of Compliance 2025-02
225848 Naproxen sodium, sumatriptan succinate Analgesics 2019-05 Issued Notice of Compliance 2020-02
193689 Necitumumab Antineoplastic agents 2016-05 Issued Notice of Compliance 2017-03
195550 Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines 2016-07 Issued Notice of Compliance 2017-10
218224 Neratinib maleate Antineoplastic agents 2018-09 Issued Notice of Compliance 2019-07
196495 Netupitant, palonosetron hydrochloride Antiemetics and antinauseants 2016-12 Issued Notice of Compliance 2017-09
216257 Nicardipine hydrochloride Calcium channel blockers 2018-07 Issued Notice of Non-compliance - Withdrawal 2020-04
216792 Niraparib Antineoplastic agents 2018-09 Issued Notice of Compliance 2019-06
259186 Nirmatrelvir, ritonavir *For use in relation to COVID-19 Antivirals for systemic use 2021-12 Issued Notice of Compliance 2022-01
269388 Nirsevimab Immune sera and immunoglobulins 2022-12 Issued Notice of Compliance 2023-04
190564 Nitisinone Other alimentary tract and metabolism products 2016-03 Issued Notice of Compliance 2016-09
193770 Nitisinone Other alimentary tract and metabolism products 2016-05 Issued Notice of Compliance 2016-11
193226 Nitisinone Other alimentary tract and metabolism products 2016-07 Issued Notice of Compliance 2016-12
253630 Nitric oxide *For use in relation to COVID-19 Other nervous system drugs 2021-06 Cancelled by sponsor 2021-09
256629 Nivolumab, relatlimab Antineoplastic agents 2022-09 Issued Notice of Compliance 2023-09
200070 Nusinersen Other drugs for disorders of the musculo-skeletal system 2016-12 Issued Notice of Compliance 2017-06
198418 Obeticholic acid Bile and liver therapy 2016-10 Issued Notice of Compliance under the NOC/c Guidance 2017-05
230825 Obiltoxaximab Immune sera and immunoglobulins 2019-10 Issued Notice of Compliance 2020-07
198094 Ocrelizumab Immunosuppressants 2016-10 Issued Notice of Compliance 2017-08
197969 Ocrelizumab Immunosuppressants 2016-10 Issued Notice of Compliance under the NOC/c Guidance 2018-02
273741 Odevixibat Bile and liver therapy 2023-05 Issued Notice of Compliance 2023-10
237346 Ofatumumab Antineoplastic agents 2020-05 Issued Notice of Compliance 2021-01
182823 Olaparib Antineoplastic agents 2015-06 Issued Notice of Compliance under the NOC/c Guidance 2016-04
203478 Olaratumab Antineoplastic agents 2017-04 Issued Notice of Compliance under the NOC/c Guidance 2017-11
275236 Olipudase alfa Other alimentary tract and metabolism products 2023-06 Issued Notice of Compliance 2024-02
279053 Omalizumab Drugs for obstructive airway diseases 2024-02 Issued Notice of Compliance 2024-12
289541 Omaveloxolone Other nervous system drugs 2024-09 Issued Notice of Compliance 2025-03
239719 Onasemnogene abeparvovec Other drugs for disorders of the musculo-skeletal system 2020-06 Issued Notice of Compliance 2020-12
188171 Osimertinib Antineoplastic agents 2015-11 Issued Notice of Compliance under the NOC/c Guidance 2016-07
222001 Ospemifene Sex hormones and modulators of the genital system 2019-03 Issued Notice of Compliance 2021-07
198865 Oxycodone Analgesics 2016-11 Cancelled by sponsor 2018-07
232761 Ozanimod hydrochloride Immunosuppressants 2019-12 Issued Notice of Compliance 2020-10
192925 Ozenoxacin Antibiotics and chemotherapy for dermatological use 2016-07 Issued Notice of Compliance 2017-05
252065 Palovarotene Other drugs for disorders of the musculo-skeletal system 2021-07 Issued Notice of Compliance 2022-01
187504 Panobinostat Antineoplastic agents 2015-11 Cancelled by sponsor 2016-06
210368 Patiromer sorbitex calcium All other therapeutic products 2017-12 Issued Notice of Compliance 2018-10
221896 Patisiran Other nervous system drugs 2018-12 Issued Notice of Compliance 2019-06
189795 Pegaspargase Antineoplastic agents 2016-05 Issued Notice of Compliance 2017-02
263432 Pegcetaclopan Immunosuppressants 2022-06 Issued Notice of Compliance 2022-12
272381 Pegcetaclopan Immunosuppressants 2023-03 Cancelled by sponsor 2025-01
204841 Pegfilgrastim Immunostimulants 2017-06 Issued Notice of Compliance 2018-04
200807 Pegfilgrastim Immunostimulants 2017-01 Issued Notice of Compliance 2018-12
220445 Pegfilgrastim Immunostimulants 2019-05 Issued Notice of Compliance 2020-04
233373 Pegfilgrastim Immunostimulants 2020-01 Issued Notice of Compliance 2020-10
232048 Pegfilgrastim Immunostimulants 2019-11 Cancelled by sponsor 2021-07
262438 Pegfilgrastim Immunostimulants 2022-05 Issued Notice of Compliance 2024-04
271699 Pegfilgrastim Immunostimulants 2023-06 Cancelled by sponsor 2024-07
262990 Pegfilgrastim Immunostimulants 2022-05 Issued Notice of Compliance 2024-08
273871 Pegfilgrastim Immunostimulants 2023-12 Issued Notice of Compliance 2024-12
251687 Pegvaliase Other alimentary tract and metabolism products 2021-06 Issued Notice of Compliance 2022-03
242569 Pemigatinib Antineoplastic agents 2020-10 Issued Notice of Compliance under the NOC/c Guidance 2021-09
191280 Peramivir Antivirals for systemic use 2016-03 Issued Notice of Compliance 2017-01
272066 Perfluorohexyloctane Ophthalmologicals 2023-08 Issued Notice of Compliance 2024-09
201189 Perindopril arginine Agents acting on the renin-angiotensin system 2017-08 Issued Notice of Compliance 2018-03
237402 Pertuzumab, trastuzumab Antineoplastic agents 2020-05 Issued Notice of Compliance 2021-03
238175 Pitolisant Other nervous system drugs 2020-05 Issued Notice of Compliance 2021-05
215288 Plecanatide Drugs for constipation 2018-12 Issued Notice of Compliance 2019-10
232303 Polatuzumab vedotin Antineoplastic agents 2019-11 Issued Notice of Compliance under the NOC/c Guidance 2020-07
239537 Ponesimod Immunosuppressants 2020-07 Issued Notice of Compliance 2021-04
208364 PrabotulinumtoxinA Muscle relaxants 2017-10 Issued Notice of Compliance 2018-08
207545 Pralatrexate Antineoplastic agents 2017-11 Issued Notice of Compliance under the NOC/c Guidance 2018-10
243731 Pralsetinib Antineoplastic agents 2020-11 Issued Notice of Compliance under the NOC/c Guidance 2021-06
252270 Pralsetinib Antineoplastic agents 2021-06 Cancelled by sponsor 2022-04
198822 Prasterone Anabolic agents for systemic use 2016-12 Issued Notice of Compliance 2019-11
211548 Progesterone Sex hormones and modulators of the genital system 2018-02 Issued Notice of Compliance 2018-08
239820 Progesterone Sex hormones and modulators of the genital system 2020-07 Issued Notice of Compliance 2021-04
188323 Propiverine hydrochloride Urologicals 2016-03 Issued Notice of Compliance 2017-01
211541 Rabies immune globulin human Immune sera and immunoglobulins 2018-01 Issued Notice of Compliance 2018-11
251162 Ranibizumab Ophthalmologicals 2021-05 Issued Notice of Compliance 2022-03
254848 Ranibizumab Ophthalmologicals 2021-09 Issued Notice of Compliance 2022-09
268288 Ranibizumab Ophthalmologicals 2022-12 Issued Notice of Compliance 2023-10
239943 Ranolazine Cardiac therapy 2020-07 Issued Notice of Compliance 2020-12
217955 Ravulizumab Immunosuppressants 2018-11 Issued Notice of Compliance 2019-08
276302 Raxtozinameran *For use in relation to COVID-19 Vaccines 2023-06 Issued Notice of Compliance 2023-09
180793 Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) Antihemorrhagics 2015-04 Issued Notice of Compliance 2016-01
230211 Recombinant haemagglutinin-strain A (H1N1) virus-like particles, Recombinant haemagglutinin-strain A (H3N2) virus-like particles, Recombinant haemagglutinin-strain B (Victoria lineage) virus-like particles, Recombinant haemagglutinin-strain B (Yamagata lineage) virus-like particles Vaccines 2019-09 Cancelled by sponsor 2021-09
235672 Recombinant influenza strain A H1N1 HA protein, recombinant influenza strain A H3N2 HA protein, recombinant influenza strain B (Victoria lineage) HA protein, recombinant influenza strain B (Yamagata lineage) HA protein Vaccines 2020-03 Issued Notice of Compliance 2021-01
252929 Regdanvimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-05 Cancelled by sponsor 2024-07
271756 RelabotulinumtoxinA Muscle relaxants 2023-03 Cancelled by sponsor 2024-01
269372 Relugolix Endocrine therapy 2022-12 Issued Notice of Compliance 2023-10
240551 Remdesivir Antivirals for systemic use 2020-06 Issued Notice of Compliance under the NOC/c Guidance 2020-07
185873 Reslizumab Immunosuppressants 2015-09 Issued Notice of Compliance 2016-07
269021 Respiratory syncytial virus prefusion F protein (RSVPreF3) Vaccines 2022-11 Issued Notice of Compliance 2023-08
284125 Retifanlimab Antineoplastic agents 2024-04 Issued Notice of Compliance 2025-02
203884 Ribociclib Antineoplastic agents 2017-05 Issued Notice of Compliance 2018-03
266189 Riltozinameran, tozinameran *For use in relation to COVID-19 Vaccines 2022-07 Issued Notice of Compliance 2022-10
268384 Rimegepant Analgesics 2023-01 Issued Notice of Compliance 2023-12
234688 Ripretinib Antineoplastic agents 2020-03 Issued Notice of Compliance 2020-06
215753 Risankizumab Immunosuppressants 2018-06 Issued Notice of Compliance 2019-04
242373 Risdiplam Other drugs for disorders of the musculo-skeletal system 2020-10 Issued Notice of Compliance 2021-04
233331 Risperidone Psycholeptics 2020-01 Issued Notice of Compliance 2020-11
264840 Risperidone Psycholeptics 2022-12 Issued Notice of Compliance 2024-03
268723 Ritlecitinib Immunosuppressants 2023-02 Issued Notice of Compliance 2023-11
207702 Rituximab Antineoplastic agents 2017-09 Cancelled by sponsor 2019-03
208107 Rituximab Antineoplastic agents 2017-09 Cancelled by sponsor 2019-03
208204 Rituximab Antineoplastic agents 2017-09 Issued Notice of Compliance 2019-04
224672 Rituximab Antineoplastic agents 2019-03 Cancelled by sponsor 2019-04
214058 Rituximab Antineoplastic agents 2018-04 Issued Notice of Compliance 2020-04
224164 Rituximab Antineoplastic agents 2019-03 Issued Notice of Compliance 2020-05
237814 Rituximab Antineoplastic agents 2020-05 Issued Notice of Compliance 2021-03
264296 Roflumilast Other dermatological preparations 2022-07 Issued Notice of Compliance 2023-04
197713 Romosozumab Drugs for treatment of bone diseases 2016-10 Issued Notice of Compliance 2019-06
271972 Ropivacaine hydrochloride Anesthetics 2023-05 Issued Notice of Compliance 2025-03
236566 Roxadustat Antianemic preparations 2020-03 Cancelled by sponsor 2021-10
274979 Rozanolixizumab Other drugs for disorders of the musculo-skeletal system 2023-11 Issued Notice of Compliance 2025-03
279310 RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) Vaccines 2024-01 Issued Notice of Compliance 2024-11
272785 RSV subgroups A, B stabilized prefusion F protein Vaccines 2023-03 Issued Notice of Compliance 2023-12
186488 Rupatadine fumarate Antihistamines for systemic use 2015-09 Issued Notice of Compliance 2016-07
269729 Ruxolitinib phosphate Other dermatological preparations 2023-03 Issued Notice of Compliance 2024-10
270055 Sabizabulin *For use in relation to COVID-19 Antivirals for systemic use 2022-11 Cancelled by sponsor 2023-06
248753 Sacituzumab govitecan Antineoplastic agents 2021-03 Issued Notice of Compliance 2021-09
207115 Safinamide Anti-parkinson drugs 2018-03 Issued Notice of Compliance 2019-01
189577 Salbutamol sulfate Drugs for obstructive airway diseases 2016-11 Issued Notice of Compliance 2017-11
191745 Sarilumab Immunosuppressants 2016-03 Issued Notice of Compliance 2017-01
254715 SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 Vaccines 2021-07 Cancelled by sponsor 2023-02
269939 SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 Vaccines 2022-12 Cancelled by sponsor 2023-02
278519 SARS-CoV-2 recombinant spike protein (Omicron XBB.1.5) *For use in relation to COVID-19 Vaccines 2023-09 Issued Notice of Compliance 2023-12
255370 SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 Vaccines 2021-08 Issued Notice of Compliance 2022-02
233642 Satralizumab Immunosuppressants 2019-12 Issued Notice of Compliance 2020-06
204085 Sebelipase alfa Other alimentary tract and metabolism products 2017-04 Issued Notice of Compliance under the NOC/c Guidance 2017-12
253182 Selinexor Antineoplastic agents 2021-08 Issued Notice of Compliance 2022-05
243748 Selpercatinib Antineoplastic agents 2020-10 Issued Notice of Compliance under the NOC/c Guidance 2021-06
243733 Selumetinib Antineoplastic agents 2020-11 Issued Notice of Compliance 2022-08
202059 Semaglutide Drugs used in diabetes 2017-03 Issued Notice of Compliance 2018-01
226906 Semaglutide Drugs used in diabetes 2019-06 Issued Notice of Compliance 2020-03
247235 Semaglutide Drugs used in diabetes 2021-01 Issued Notice of Compliance 2021-11
268412 Setmelanotide acetate Antiobesity preparations, excluding diet products 2022-11 Issued Notice of Compliance 2023-05
283047 Sipavibart Immune sera and immunoglobulins 2024-03 Issued Notice of Compliance 2025-03
223225 Siponimod Immunosuppressants 2019-02 Issued Notice of Compliance 2020-02
205568 Sirukumab Immunosuppressants 2017-06 Cancelled by sponsor 2017-10
270800 Smallpox vaccine dried Vaccines 2023-02 Issued Notice of Compliance 2023-12
225953 Sodium chloride, sodium citrate Blood substitutes and perfusion solutions 2019-05 Issued Notice of Compliance 2020-03
231915 Sodium pertechnetate Tc-99m Diagnostic radiopharmaceuticals 2020-01 Issued Notice of Compliance 2020-11
253502 Sodium phenylbutyrate, ursodoxicoltaurine Other nervous system drugs 2021-08 Issued Notice of Compliance under the NOC/c Guidance 2022-06
218799 Sodium zirconium cyclosilicate All other therapeutic products 2018-09 Issued Notice of Compliance 2019-07
190521 Sofosbuvir, velpatasvir Antivirals for systemic use 2016-01 Issued Notice of Compliance 2016-07
202324 Sofosbuvir, velpatasvir, voxilaprevir Antivirals for systemic use 2017-02 Issued Notice of Compliance 2017-08
237511 Solriamfetol hydrochloride Psychoanaleptics 2020-07 Issued Notice of Compliance 2021-05
267443 Somapacitan Pituitary and hypothalamic hormones and analogues 2022-09 Issued Notice of Compliance 2023-07
246729 Somatrogon Pituitary and hypothalamic hormones and analogues 2020-12 Issued Notice of Compliance 2021-10
229407 Sonidegib Antineoplastic agents 2019-08 Issued Notice of Compliance 2020-06
217853 Sotagliflozin Drugs used in diabetes 2018-08 Cancelled by sponsor 2019-06
283307 Sotatercept Antihypertensives 2024-03 Issued Notice of Compliance 2024-08
248435 Sotorasib Antineoplastic agents 2021-02 Issued Notice of Compliance under the NOC/c Guidance 2021-09
251285 Sotrovimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-04 Authorized under Interim Order 2021-07
257895 Sotrovimab *For use in relation to COVID-19 Immune sera and immunoglobulins 2021-10 Cancelled by sponsor 2024-04
267362 Spesolimab Immunosuppressants 2022-09 Issued Notice of Compliance 2023-03
201492 Sucroferric oxyhydroxide All other therapeutic products 2017-02 Issued Notice of Compliance 2018-01
180385 Sugammadex All other therapeutic products 2015-04 Issued Notice of Compliance 2016-02
196367 Suvorexant Psycholeptics 2016-08 Issued Notice of Compliance 2018-11
209210 Tacrolimus Immunosuppressants 2018-04 Issued Notice of Compliance 2019-02
240239 Tafamidis Other nervous system drugs 2020-09 Issued Notice of Compliance 2021-07
228368 Tafamidis meglumine Other nervous system drugs 2019-07 Issued Notice of Compliance 2020-01
247025 Tafasitamab Antineoplastic agents 2020-12 Issued Notice of Compliance 2021-08
220584 Talazoparib Antineoplastic agents 2018-11 Issued Notice of Compliance 2019-09
278277 Talquetamab Antineoplastic agents 2023-09 Issued Notice of Compliance under the NOC/c Guidance 2024-04
281963 Tarlatamab Antineoplastic agents 2024-01 Issued Notice of Compliance under the NOC/c Guidance 2024-09
236286 Tazarotene Antipsoriatics 2020-09 Issued Notice of Compliance 2021-07
258717 Tebentafusp Antineoplastic agents 2021-12 Issued Notice of Compliance 2022-06
269369 Teclistamab Antineoplastic agents 2022-12 Issued Notice of Compliance under the NOC/c Guidance 2023-07
247561 Tecovirimat monohydrate Antivirals for systemic use 2021-02 Issued Notice of Compliance 2021-11
208730 Telotristat etiprate Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 2017-12 Issued Notice of Compliance 2018-10
224850 Tenapanor Drugs for constipation 2019-06 Issued Notice of Compliance 2020-04
193066 Tenofovir alafenamide hemifumarate Antivirals for systemic use 2016-07 Issued Notice of Compliance 2017-05
242300 Tepotinib Antineoplastic agents 2020-10 Issued Notice of Compliance under the NOC/c Guidance 2021-05
215409 Teriparatide Calcium homeostasis 2018-06 Issued Notice of Compliance 2020-01
256188 Tezepelumab Drugs for obstructive airway diseases 2021-10 Issued Notice of Compliance 2022-07
206099 Tibolone Sex hormones and modulators of the genital system 2017-10 Issued Notice of Compliance 2019-05
224036 Tildrakizumab Immunosuppressants 2019-02 Issued Notice of Compliance 2021-05
205852 Tipiracil hydrochloride, trifluridine Antineoplastic agents 2017-07 Issued Notice of Compliance 2018-01
262080 Tirbanibulin Antibiotics and chemotherapy for dermatological use 2022-07 Issued Notice of Compliance 2023-05
259103 Tirzepatide Drugs used in diabetes 2022-02 Issued Notice of Compliance 2022-11
213547 Tisagenlecleucel-T Antineoplastic agents 2018-03 Issued Notice of Compliance 2018-09
213698 Tisagenlecleucel-T Antineoplastic agents 2018-03 Issued Notice of Compliance 2018-09
280011 Tocilizumab Immunosuppressants 2023-12 Issued Notice of Compliance 2024-10
283158 Tofersen Other nervous system drugs 2024-03 Issued Notice of Compliance under the NOC/c Guidance 2025-02
244906 Tozinameran *For use in relation to COVID-19 Vaccines 2020-10 Authorized under Interim Order 2020-12
252736 Tozinameran *For use in relation to COVID-19 Vaccines   Issued Notice of Compliance 2021-09
245877 Tralokinumab Other dermatological preparations 2020-12 Issued Notice of Compliance 2021-10
204579 Trastuzumab Antineoplastic agents 2017-06 Issued Notice of Compliance 2019-05
212140 Trastuzumab Antineoplastic agents 2018-02 Issued Notice of Compliance 2019-08
210238 Trastuzumab Antineoplastic agents 2017-11 Issued Notice of Compliance 2019-09
208836 Trastuzumab Antineoplastic agents 2017-10 Issued Notice of Compliance 2020-02
235995 Trastuzumab Antineoplastic agents 2020-04 Issued Notice of Compliance 2022-01
253850 Trastuzumab Antineoplastic agents 2021-08 Cancelled by sponsor 2023-06
275910 Trastuzumab Antineoplastic agents 2023-07 Issued Notice of Compliance 2024-08
242104 Trastuzumab deruxtecan Antineoplastic agents 2020-08 Issued Notice of Compliance under the NOC/c Guidance 2021-04
262740 Tremelimumab Antineoplastic agents 2022-05 Issued Notice of Compliance 2023-08
231223 Treosulfan Antineoplastic agents 2020-01 Issued Notice of Deficiency - Withdrawal 2021-06
244137 Treosulfan Antineoplastic agents 2020-12 Issued Notice of Compliance 2021-06
201546 Triamcinolone hexacetonide Corticosteroids for systemic use 2017-02 Issued Notice of Compliance 2017-12
228708 Trientine hydrochloride Other alimentary tract and metabolism products 2019-11 Issued Notice of Compliance 2020-09
237287 Trientine hydrochloride All other therapeutic products 2020-06 Issued Notice of Compliance 2021-04
221945 Trifarotene Anti-acne preparations 2019-01 Issued Notice of Compliance 2019-11
242196 Triheptanoin Other alimentary tract and metabolism products 2020-08 Issued Notice of Compliance 2021-02
285051 Trofinetide Other nervous system drugs 2024-04 Issued Notice of Compliance 2024-10
235295 Tucatinib Antineoplastic agents 2020-02 Issued Notice of Compliance 2020-06
256191 Ubrogepant Analgesics 2021-10 Issued Notice of Compliance 2022-11
223734 Upadacitinib Immunosuppressants 2019-03 Issued Notice of Compliance 2019-12
268742 Ustekinumab Immunosuppressants 2023-01 Issued Notice of Compliance 2023-11
269097 Ustekinumab Immunosuppressants 2023-03 Issued Notice of Compliance 2023-12
274939 Ustekinumab Immunosuppressants 2023-08 Issued Notice of Compliance 2024-07
277532 Ustekinumab Immunosuppressants 2023-10 Issued Notice of Compliance 2024-08
278712 Ustekinumab Immunosuppressants 2023-10 Issued Notice of Compliance 2024-08
279373 Ustekinumab Immunosuppressants 2024-03 Issued Notice of Compliance 2024-12
200244 Varicella-zoster virus glycoprotein E (GE) Vaccines 2016-12 Issued Notice of Compliance 2017-10
190761 Venetoclax Antineoplastic agents 2016-02 Issued Notice of Compliance under the NOC/c Guidance 2016-09
240862 Vericiguat Cardiac therapy 2021-01 Issued Notice of Compliance 2023-04
190817 Vernakalant hydrochloride Cardiac therapy 2016-05 Issued Notice of Compliance 2017-03
264995 Vibrio cholerae, strain CVD 103-HgR, live Vaccines 2022-07 Issued Notice of Compliance 2023-05
254598 Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 Vaccines 2021-08 Issued Notice of Compliance 2022-02
219321 Vitamin D3 Vitamins 2019-01 Issued Notice of Compliance 2021-02
225983 Vitamin K1 Antihemorrhagics 2019-08 Issued Notice of Deficiency - Withdrawal 2021-06
209280 Volanesorsen Lipid modifying agents 2017-11 Issued Notice of Non-compliance - Withdrawal 2018-11
213188 Vonicog alfa Antihemorrhagics 2018-03 Issued Notice of Compliance 2019-01
282910 Vorasidenib citrate Antineoplastic agents 2024-03 Issued Notice of Compliance 2024-08
233097 Voretigene neparvovec Ophthalmologicals 2019-12 Issued Notice of Compliance 2020-10
267923 Vutrisiran Other nervous system drugs 2022-12 Issued Notice of Compliance 2023-10
254518 Whole virion inactivated coronavirus *For use in relation to COVID-19 Vaccines 2021-07 Cancelled by sponsor 2022-08
242748 Zanubrutinib Antineoplastic agents 2020-09 Issued Notice of Compliance 2021-03
242885 Zanubrutinib Antineoplastic agents 2020-09 Issued Notice of Compliance 2021-07
276757 Zilucoplan Immunosuppressants 2023-08 Issued Notice of Compliance 2024-07
212392 Zofenopril calcium Agents acting on the renin-angiotensin system 2018-06 Cancelled by sponsor 2019-06
282144 Zolbetuximab Antineoplastic agents 2024-02 Issued Notice of Compliance 2024-12
Footnote a

For more information about Notices of Compliance issued under the Guidance Document: Notice of Compliance with Conditions (available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html), including whether conditions have been met, please visit "Notice of Compliance with conditions (NOC/c)" (available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html).

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