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Full Name:Amgen Inc. | Industry:biological products (diagnostic and non diagnostic) | CIK:318154 | Fiscal Year End:12-31 | State/Country:CALIFORNIA |
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Instructions
US clinical trial status
Size of symbol reflects the phase of clinical trial. E.g. Phase 3 trial has the largest size.
Shape definition
▲ Up-triangle: study first submitted.
◼ Square: study completion(actual/anticipated).
⬤ Circle: result first posted.
Color definition
▶ Green: study is ongoing.
▶ Blue: recruitment completed.
▶ Red: study aborted/terminated/withdrawn.
▶ Pink: study in abnormal state.
US FDA submission
Size of symbol reflects the type of submission. E.g. Type 1 drug has the largest size.
◆: Approved.
◆: Tentative Approval.
Drug marketing & current status
Circle bubble denotes new drug marketing. Size is determined by drug type and market(i.e. population) size. E.g. Type 1 drug marketed in US has the largest size. Drug marketed in CA has the smallest size due to small population size.
Color definition
⬤ Blue circle: drug marketed (EU,CA), FDA submission approved (US).
⬤ Cyan circle: drug approved (CA), tentative approval (US), received positive opinion (EU)
⬤ Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.
Drug marketing status change
Square bubble denotes marketing status change. Size is determined by drug type and market(i.e. population) size.
Color definition
◼ Blue square: change from other status to marketed.
◼ Cyan square: change from other status to tentative status.
◼ Red square: change from other status to abnormal or withdrawn status.
Clinical Trials Summary Statistics
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 1 ⬤ | 1 | ||||||
2024 | ||||||||
2023 | 1 ⬤ | |||||||
2022 |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 10 ⬤ | 9 ⬤ | 1 ⬤ | 155 ⬤ | 1 | 30 ⬤ | 6 ⬤ | |
2024 | 3 ⬤ | 1 ⬤ | 1 ⬤ | 1 | ||||
2023 | 2 ⬤ | 12 | 1 ⬤ | |||||
2022 | 3 ⬤ | 2 | 14 |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 5 ⬤ | 1 ⬤ | 25 ⬤ | 7 | 1 | |||
2024 | ||||||||
2023 | 1 ⬤ | |||||||
2022 | 1 ⬤ |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 2 ⬤ | 5 ⬤ | 2 ⬤ | 167 ⬤ | 4 | 22 ⬤ | 4 | |
2024 | 1 ⬤ | |||||||
2023 | 1 ⬤ | 1 | ||||||
2022 | 1 | 1 ⬤ | 2 ⬤ | 1 |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 5 | |||||||
2024 | ||||||||
2023 | ||||||||
2022 |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 25 ⬤ | 12 ⬤ | 4 ⬤ | 190 ⬤ | 22 ⬤ | 3 | ||
2024 | 1 ⬤ | 4 ⬤ | ||||||
2023 | 11 ⬤ | 2 ⬤ | 1 | |||||
2022 | 3 ⬤ | 3 ⬤ |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 5 ⬤ | 2 ⬤ | 1 ⬤ | 56 ⬤ | 5 | 1 | ||
2024 | 1 ⬤ | |||||||
2023 | 2 ⬤ | |||||||
2022 | 1 ⬤ |
Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
ALL | 6 | 1 | ||||||
2024 | ||||||||
2023 | ||||||||
2022 | 1 |
- Recruiting
- Active, Not Recruiting
- Not Yet Recruiting
- Completed
- Unknown Status
- Suspended
- Terminated
- Withdrawn
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 1 ⬤ | 10 ⬤ | 5 ⬤ | 2 ⬤ | 25 ⬤ | 5 ⬤ | ||
2024 | 3 ⬤ | 1 ⬤ | ||||||
2023 | 1 ⬤ | 2 ⬤ | 1 ⬤ | 1 ⬤ | 11 ⬤ | 2 ⬤ | ||
2022 | 3 ⬤ | 1 ⬤ | 3 ⬤ | 1 ⬤ |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 9 ⬤ | 1 ⬤ | 5 ⬤ | 12 ⬤ | 2 ⬤ | |||
2024 | 1 ⬤ | |||||||
2023 | 2 ⬤ | |||||||
2022 | 2 | 1 | 3 ⬤ |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 1 ⬤ | 2 ⬤ | 4 ⬤ | 1 ⬤ | ||||
2024 | 1 ⬤ | 1 ⬤ | 4 ⬤ | 1 ⬤ | ||||
2023 | 1 | |||||||
2022 |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 155 ⬤ | 25 ⬤ | 167 ⬤ | 5 | 190 ⬤ | 56 ⬤ | 6 | |
2024 | 1 | |||||||
2023 | 12 | 1 | ||||||
2022 | 14 | 1 ⬤ | 1 |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 4 | |||||||
2024 | ||||||||
2023 | ||||||||
2022 |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 1 | |||||||
2024 | ||||||||
2023 | ||||||||
2022 |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 1 | 30 ⬤ | 7 | 22 ⬤ | 22 ⬤ | 5 | 1 | |
2024 | ||||||||
2023 | ||||||||
2022 | 2 ⬤ |
Year | Early Phase 1 | Phase 1 | Phase 1|Phase 2 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 | Others |
---|---|---|---|---|---|---|---|---|
ALL | 6 ⬤ | 1 | 4 | 3 | 1 | |||
2024 | ||||||||
2023 | 1 ⬤ | |||||||
2022 | 1 |
Phase | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
Early Phase 1 | 1 ⬤ | 1 | ||||||
Phase 1 | 10 ⬤ | 9 ⬤ | 1 ⬤ | 155 ⬤ | 1 | 30 ⬤ | 6 ⬤ | |
Phase 1|Phase 2 | 5 ⬤ | 1 ⬤ | 25 ⬤ | 7 | 1 | |||
Phase 2 | 2 ⬤ | 5 ⬤ | 2 ⬤ | 167 ⬤ | 4 | 22 ⬤ | 4 | |
Phase 2|Phase 3 | 5 | |||||||
Phase 3 | 25 ⬤ | 12 ⬤ | 4 ⬤ | 190 ⬤ | 22 ⬤ | 3 | ||
Phase 4 | 5 ⬤ | 2 ⬤ | 1 ⬤ | 56 ⬤ | 5 | 1 | ||
Others | 6 | 1 |
Phase | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
Early Phase 1 | ||||||||
Phase 1 | 3 ⬤ | 1 ⬤ | 1 ⬤ | 1 | ||||
Phase 1|Phase 2 | ||||||||
Phase 2 | 1 ⬤ | |||||||
Phase 2|Phase 3 | ||||||||
Phase 3 | 1 ⬤ | 4 ⬤ | ||||||
Phase 4 | 1 ⬤ | |||||||
Others |
Phase | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
Early Phase 1 | 1 ⬤ | |||||||
Phase 1 | 2 ⬤ | 12 | 1 ⬤ | |||||
Phase 1|Phase 2 | 1 ⬤ | |||||||
Phase 2 | 1 ⬤ | 1 | ||||||
Phase 2|Phase 3 | ||||||||
Phase 3 | 11 ⬤ | 2 ⬤ | 1 | |||||
Phase 4 | 2 ⬤ | |||||||
Others |
Phase | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Unknown Status | Suspended | Terminated | Withdrawn |
---|---|---|---|---|---|---|---|---|
Early Phase 1 | ||||||||
Phase 1 | 3 ⬤ | 2 | 14 | |||||
Phase 1|Phase 2 | 1 ⬤ | |||||||
Phase 2 | 1 | 1 ⬤ | 2 ⬤ | 1 | ||||
Phase 2|Phase 3 | ||||||||
Phase 3 | 3 ⬤ | 3 ⬤ | ||||||
Phase 4 | 1 ⬤ | |||||||
Others | 1 |
Note: "Year" represents clinical trail start year determined by study first submit date.
Three grouping strategies present the same statistical data from different angles, choose any one you are comfortable with.
⬤ at least one study with latest update posted within 7 days.
⬤ at least one study with latest update posted within 30 days.
⬤ at least one study with latest update posted within 90 days.
Clinical Trials Records
Sponsor | Overall Status | Phase | Brief Title | Disease Condition | Intervention Name | Study First Submit Date | Last Update Post Date | Results First Post Date | Completion Date | Completion Date Type | Enrollment Count |
---|---|---|---|---|---|---|---|---|---|---|---|
Amgen | Not yet recruiting | Phase 3 | Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV | Vasculitis | Avacopan | 2024-03-14 | 2024-03-20 | 2030-04-28 | Anticipated | 20 | |
Amgen | Not yet recruiting | Phase 3 | A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer | Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer | ABP 234|Pembrolizumab (US)|Pembrolizumab (EU) | 2024-03-08 | 2024-04-02 | 2027-10-22 | Anticipated | 927 | |
Amgen | Recruiting | Phase 3 | A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD | Atopic Dermatitis | Rocatinlimab Prefilled Syringe | 2024-01-17 | 2024-04-19 | 2026-04-22 | Anticipated | 100 | |
Amgen | Not yet recruiting | Phase 3 | Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation | Metastatic Colorectal Cancer | FOLFIRI Regimen|Sotorasib|Panitumumab|Bevacizumab-awwb | 2024-01-15 | 2024-02-12 | 2030-11-27 | Anticipated | 450 | |
Amgen | Not yet recruiting | Phase 3 | Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab | Extensive-Stage Small-Cell Lung Cancer|Small-Cell Lung Cancer | Tarlatamab|Durvalumab | 2024-01-08 | 2024-01-18 | 2028-09-25 | Anticipated | 550 | |
Amgen | Recruiting | Phase 3 | A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO) | Plaque Psoriasis | apremilast|Placebo | 2023-11-03 | 2024-03-28 | 2025-12-24 | Anticipated | 200 | |
Amgen | Recruiting | Phase 3 | Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) | Limited Stage Small Cell Lung Cancer|Small Cell Lung Cancer | Tarlatamab|Placebo | 2023-10-31 | 2024-04-25 | 2029-10-31 | Anticipated | 400 | |
Amgen | Recruiting | Phase 3 | A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis | Plaque Psoriasis | Apremilast | 2023-10-12 | 2024-04-25 | 2026-12-17 | Anticipated | 50 | |
Amgen | Recruiting | Phase 3 | A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma | Melanoma | ABP 206|Nivolumab | 2023-09-20 | 2024-04-25 | 2027-01-25 | Anticipated | 620 | |
Amgen | Recruiting | Phase 3 | Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta | Osteogenesis Imperfecta | Romosozumab|Bisphosphonate | 2023-07-24 | 2024-04-23 | 2027-09-10 | Anticipated | 106 | |
Amgen | Recruiting | Phase 3 | A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma | Melanoma | ABP 206|FDA-licensed Nivolumab|EU-authorized Nivolumab | 2023-06-08 | 2024-04-25 | 2025-07-30 | Anticipated | 249 | |
Amgen | Active, not recruiting | Phase 3 | A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER) | Atopic Dermatitis|Moderate-to-severe Atopic Dermatitis | Rocatinlimab|Placebo | 2023-06-02 | 2024-03-07 | 2024-11-06 | Anticipated | 221 | |
Amgen | Recruiting | Phase 3 | A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202) | Non-Small Cell Lung Cancer (NSCLC) | Sotorasib|Pembrolizumab | 2023-05-23 | 2024-03-22 | 2031-03-01 | Anticipated | 750 | |
Amgen | Recruiting | Phase 3 | A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) | Atopic Dermatitis | Rocatinlimab|Placebo | 2023-05-22 | 2024-03-28 | 2027-06-04 | Anticipated | 2200 | |
Amgen | Recruiting | Phase 3 | A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis | Behçet's Disease|Juvenile Psoriatic Arthritis | Apremilast | 2023-03-08 | 2024-02-15 | 2032-12-29 | Anticipated | 48 | |
Amgen | Recruiting | Phase 3 | Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer | Small Cell Lung Cancer (SCLC) | Tarlatamab|Lurbinectedin|Topotecan|Amrubicin | 2023-02-07 | 2024-04-25 | 2027-08-01 | Anticipated | 490 | |
Amgen | Active, not recruiting | Phase 3 | A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) | Atopic Dermatitis | Rocatinlimab|Placebo | 2023-02-02 | 2024-04-24 | 2025-01-06 | Anticipated | 746 | |
Amgen | Recruiting | Phase 3 | A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) | Atopic Dermatitis | Rocatinlimab|Placebo | 2023-01-20 | 2024-04-25 | 2025-12-18 | Anticipated | 500 | |
Amgen | Completed | Phase 3 | A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) | Chorioretinal Vascular Disease | ABP 938|Aflibercept | 2023-01-20 | 2023-11-18 | 2023-03-24 | Actual | 49 | |
Amgen | Active, not recruiting | Phase 3 | A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) | Atopic Dermatitis | Rocatinlimab|Placebo | 2022-12-07 | 2024-01-08 | 2024-09-26 | Anticipated | 726 | |
Amgen | Recruiting | Phase 3 | A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) | Atopic Dermatitis | Rocatinlimab | 2022-11-22 | 2024-04-25 | 2025-07-21 | Anticipated | 170 | |
Amgen | Active, not recruiting | Phase 3 | Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial | Atherosclerotic Cardiovascular Disease | Placebo|Olpasiran | 2022-10-12 | 2024-04-04 | 2026-12-29 | Anticipated | 7297 | |
Amgen | Recruiting | Phase 3 | A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis | Plaque Psoriasis | Apremilast | 2022-09-20 | 2023-10-06 | 2026-09-06 | Anticipated | 33 | |
Amgen | Recruiting | Phase 3 | A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) | Atopic Dermatitis | Rocatinlimab|Placebo | 2022-05-24 | 2024-04-19 | 2025-03-30 | Anticipated | 700 | |
Amgen | Active, not recruiting | Phase 3 | Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation | Colorectal Cancer (CRC) | Sotorasib|Panitumumab|Trifluridine and Tipiracil|Regorafenib | 2022-01-06 | 2024-03-04 | 2025-03-12 | Anticipated | 160 |
Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "phase 3" (case insensitive, with double quote) to show Phase 3 trials.
⬤ latest update posted within 7 days.
⬤ latest update posted within 30 days.
⬤ latest update posted within 90 days.
US FDA Submission Summary Statistics*
Year | TYPE 1 | TYPE 2/4 | TYPE 3 | TYPE 5 | EFFICACY | UNKNOWN |
---|---|---|---|---|---|---|
ALL | 15 | 1 | 1 | 1 | 1 | 4 |
2024 | ||||||
2023 | 2 | |||||
2022 |
Note: "Year" determined by submission status date.
* Original submissions only. Supplementary records not counted.
⬤ at least one submission within 7 days.
⬤ at least one submission within 30 days.
⬤ at least one submission within 90 days.
US FDA Submission Records
Sponsor | Application Type | Drug Name | Active Ingredient | Submission Code | Submission Type | Submission Status | Status Date | Application Number |
---|---|---|---|---|---|---|---|---|
Amgen Inc | BLA | Wezlana | Ustekinumab Auub | Unknown | Orig | Approval | 2023-10-31 | 761285 |
Amgen Inc | BLA | Wezlana | Ustekinumab Auub | Unknown | Orig | Approval | 2023-10-31 | 761331 |
Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "NDA" (case insensitive) to show records with "NDA" (New Drug Applications) tag.
⬤ submission status date within 7 days.
⬤ submission status date within 30 days.
⬤ submission status date within 90 days.
Category | Sponsor | Marketing Date | Current Marketing Status | Drug Name | Active Ingredient | Submission Status Date | Submission Code | Submission Status | Marketing Status Change Date |
---|---|---|---|---|---|---|---|---|---|
Human Non-Bioproduct | Amgen Inc | 2023-10-31 | Prescription | Wezlana | Ustekinumab Auub | 2023-10-31 | Unknown | Approval | 2023-11-30 |
Human Non-Bioproduct | Amgen Inc | 2023-10-31 | Prescription | Wezlana | Ustekinumab Auub | 2023-10-31 | Unknown | Approval | 2023-11-30 |
Human Non-Bioproduct | Amgen Inc | 2023-10-31 | Prescription | Wezlana | Ustekinumab Auub | 2023-10-31 | Unknown | Approval | 2023-11-30 |
Human Non-Bioproduct | Amgen Inc | 2023-10-31 | Prescription | Wezlana | Ustekinumab Auub | 2023-10-31 | Unknown | Approval | 2023-11-30 |
Human Non-Bioproduct | Amgen Inc | 2023-10-31 | Prescription | Wezlana | Ustekinumab Auub | 2023-10-31 | Unknown | Approval | 2023-11-30 |
Human Non-Bioproduct | Amgen Inc | 2023-10-31 | Prescription | Wezlana | Ustekinumab Auub | 2023-10-31 | Unknown | Approval | 2023-11-30 |
Human Non-Bioproduct | Amgen Inc | 2021-05-28 | Prescription | Lumakras | Sotorasib | 2021-05-28 | Type 1 | Approval | 2023-11-30 |
Note: This table contains human and animal drugs regulated by US FDA, and biological products regulated by CBER (Center for Biologics Evaluation and Research).
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "discontinued" (case insensitive) to show discontinued drug products.
For human non-bioproduct, marketing date was set to submission approval date.
Possible marketing statuses: Marketed, Prescription, Over-the-counter, Discontinued, None (Tentative Approval).
⬤ any of (marketing/submission/status change) within 7 days.
⬤ any of (marketing/submission/status change) within 30 days.
⬤ any of (marketing/submission/status change) within 90 days.
Category | Sponsor | Authorization Date | Current Marketing Status | Latest Status Update | Drug Name | Active Ingredient | Withdraw Date | Opinion Date | Summary of Opinion |
---|---|---|---|---|---|---|---|---|---|
Human | Amgen Technology (Ireland) Uc | 2023-04-19 | Authorised | 2023-05-15 | Bekemv | Eculizumab | |||
Human | Amgen Europe Bv | 2022-01-06 | Authorised | 2022-03-31 | Lumykras | Sotorasib |
Note: This table contains human and animal drugs regulated by EMA (European Medicines Agency), and summary of opinion published by EMA based on the CHMP's or CVMP's positive or negative recommendation.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "withdrawn" (case insensitive) to show drugs withdrawn.
Possible marketing statuses: Authorised, Refused, Withdrawn, Summary of Opinion.
Summary of Opinion: published by European Medicines Agency (EMA) based on the CHMP's or CVMP's positive or negative recommendation. Further marketing authorization is partially based on this opinion.
⬤ any of (authorization/withdrawn/opinion/status change) date within 7 days.
⬤ any of (authorization/withdrawn/opinion/status change) date within 30 days.
⬤ any of (authorization/withdrawn/opinion/status change) date within 90 days.
Category | Sponsor | Authorization Date | Current Marketing Status | Status Date | Drug Name | Active Ingredient |
---|---|---|---|---|---|---|
Human | Amgen Canada Inc | 2023-12-27 | Marketed | 2024-03-01 | Wezlana | Ustekinumab (45 Mg) |
Human | Amgen Canada Inc | 2023-12-27 | Marketed | 2024-03-01 | Wezlana | Ustekinumab (90 Mg) |
Human | Amgen Canada Inc | 2023-12-27 | Marketed | 2024-03-01 | Wezlana | Ustekinumab (45 Mg) |
Human | Amgen Canada Inc | 2023-12-27 | Marketed | 2024-03-01 | Wezlana I.V. | Ustekinumab (5 Mg) |
Human | Amgen Canada Inc | 2021-03-11 | Dormant | 2023-12-03 | Riabni | Rituximab (10 Mg) |
Human | Amgen Canada Inc | 2014-11-12 | Marketed | 2022-01-10 | Otezla | Apremilast (10 Mg)|Apremilast (20 Mg)|Apremilast (30 Mg) |
Note: This table contains human, animal drugs, radiopharmaceutical and disinfectant regulated by CFIA(Canadian Food Inspection Agency) and Health Canada.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "marketed" (case insensitive) to show drugs marketed.
Possible marketing statuses: Marketed, Approved, Dormant, Cancelled Pre Market, Cancelled Post Market, Cancelled (Safety Issue), Cancelled (Unreturned Annual).
⬤ any of (authorization/status change) date within 7 days.
⬤ any of (authorization/status change) date within 30 days.
⬤ any of (authorization/status change) date within 90 days.