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Regulatory
Every record is one authority's decision for one application or DIN, shown with its jurisdiction, date, indication text as published and status. A molecule approved in one jurisdiction for one indication is not 'approved' in general.
RegulatoryDevelopment pipeline →Methodology
Coverage
Counts of records, not of drugs approved: one application can carry several dated records (original approval, efficacy supplements, one row per DIN in Canada).
Approval records
4,342
Distinct drugs
373
Records naming a cancer
982
Dated in the last 12 months
177
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |
|---|---|---|---|---|---|---|---|
| FDA | US | 2,343 | 304 | 2,343 | 0 | 115 | Sep 18, 2026 |
| Health Canada | CA | 1,538 | 273 | 979 | 559 | 42 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 2 days agoSource updated unknown3 authority · jurisdiction pairs ingested
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Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 25, 2005 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | Efficacy supplement 2005-02-25 (see label) | SUPPLBLA103964 | approved | openfda |
| Feb 7, 2005 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-PACLITAXEL INJECTABLE (DIN 02248844) under ATC L01CD01 PACLITAXEL. Indications are not published in the Drug… | DIN02248844 | withdrawnsource: Dormantsince Aug 4, 2017 | health-canada-dpd |
| Feb 1, 2005 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VELCADE (DIN 02262452) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug Product Database — see… | DIN02262452 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 28, 2005 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 2005-01-28 (see label) | SUPPLNDA050718 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 22, 2004 | Vinorelbine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINORELBINE TARTRATE FOR INJECTION (DIN 02257777) under ATC L01CA04 VINORELBINE. Indications are not published in the… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 15, 2004 | Anagrelide | EMA EU | cancer not stated in this record | Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 20, 2004 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 19, 2004 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2004-08-19 (see label) | SUPPLNDA020990 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2004 | Cetuximab | EMA EU | cancer not stated in this record | Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2004 | Peginterferon Alfa-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEGASYS RBV (DIN 02253429) under ATC L03AB61 PEGINTERFERON ALFA-2A, COMBINATIONS. Indications are not published in… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 2004 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELIGARD (DIN 02248999) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database —… | DIN02248999 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 26, 2004 | Interferon Beta-1a | FDA US | cancer not stated in this record | Efficacy supplement 2004-03-26 (see label) | SUPPLBLA103780 | approved | openfda |
A record is one authority's decision for one application/DIN; the same molecule appears once per jurisdiction and indication. Health Canada DPD does not publish indications — its records state the brand, DIN and ATC class only, and a cancelled or dormant DIN is the status of one product, not of the molecule. FDA cancer mappings come from label text and are flagged probabilistic on the drug page.
| Jan 12, 2005 | Bevacizumab | EMA EU | cancer not stated in this record | Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma… | centralisedEMEA/H/C/000582 | approved | ema |
| Jan 7, 2005 | Paclitaxel | FDA US | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | ORIGNDA021660 | approved | openfda |
| Jan 7, 2005 | Paclitaxel | FDA US | Lung Non-Small Cell Carcinoma | Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who… | ORIGNDA021660 | approved | openfda |
| Jan 7, 2005 | Paclitaxel | FDA US | Malignant Breast Neoplasm | Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant… | ORIGNDA021660 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Apr 6, 2021 |
| health-canada-dpd |
| Dec 14, 2004 | Leuprolide | FDA US | Malignant Prostate Neoplasm | VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated… | ORIGNDA021731 | approved | openfda |
| Dec 10, 2004 | Anagrelide | FDA US | cancer not stated in this record | Efficacy supplement 2004-12-10 (see label) | SUPPLNDA020333 | approved | openfda |
| centralisedEMEA/H/C/000480 |
| approved |
| ema |
| Nov 5, 2004 | Anagrelide | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ ANAGRELIDE (DIN 02260107) under ATC L01XX35 ANAGRELIDE. Indications are not published in the Drug Product… | DIN02260107 | withdrawnsource: Cancelled Post Marketsince Feb 4, 2020 | health-canada-dpd |
| Oct 27, 2004 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 2004-10-27 (see label) | SUPPLNDA050718 | approved | openfda |
| Oct 25, 2004 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as GLEEVEC (DIN 02253283) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see… | DIN02253283 | approvedsource: Marketed | health-canada-dpd |
| Oct 22, 2004 | Ibritumomab Tiuxetan | FDA US | cancer not stated in this record | Efficacy supplement 2004-10-22 (see label) | SUPPLBLA125019 | approved | openfda |
| Oct 22, 2004 | Cinacalcet | EMA EU | cancer not stated in this record | Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Mimpara… | centralisedEMEA/H/C/000575 | withdrawnsince Dec 5, 2008 | ema |
| Oct 22, 2004 | Cinacalcet | EMA EU | Parathyroid Carcinoma | Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD)… | centralisedEMEA/H/C/000570 | withdrawnsince Dec 18, 2025 | ema |
| centralisedEMEA/H/C/000564 |
| approved |
| ema |
| Sep 17, 2004 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEGETRON (DIN 02254646) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published in the… | DIN02254646 | withdrawnsource: Cancelled Post Marketsince Oct 5, 2017 | health-canada-dpd |
| Sep 17, 2004 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEGETRON (DIN 02254638) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published in the… | DIN02254638 | withdrawnsource: Cancelled Post Marketsince Oct 5, 2017 | health-canada-dpd |
| Sep 17, 2004 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEGETRON (DIN 02254603) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published in the… | DIN02254603 | withdrawnsource: Cancelled Post Marketsince Oct 5, 2017 | health-canada-dpd |
| Sep 17, 2004 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEGETRON (DIN 02254581) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published in the… | DIN02254581 | withdrawnsource: Cancelled Post Marketsince Oct 5, 2017 | health-canada-dpd |
| Aug 19, 2004 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2004-08-19 (see label) | SUPPLNDA019839 | approved | openfda |
| Aug 18, 2004 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 2004-08-18 (see label) | SUPPLNDA020449 | approved | openfda |
| Aug 3, 2004 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as ALIMTA (DIN 02253437) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see… | DIN02253437 | withdrawnsource: Cancelled Post Marketsince Sep 17, 2021 | health-canada-dpd |
| centralisedEMEA/H/C/000558 |
| approved |
| ema |
| Jun 24, 2004 | Irinotecan | FDA US | cancer not stated in this record | Efficacy supplement 2004-06-24 (see label) | SUPPLNDA020571 | approved | openfda |
| Jun 14, 2004 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FASLODEX (DIN 02248624) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product Database —… | DIN02248624 | approvedsource: Marketed | health-canada-dpd |
| Jun 3, 2004 | Aminolevulinic Acid | Health Canada CA | cancer not stated in this record | Marketed in Canada as LEVULAN KERASTICK (DIN 02243933) under ATC L01XD04 AMINOLEVULINIC ACID. Indications are not published in the Drug… | DIN02243933 | approvedsource: Marketed | health-canada-dpd |
| Jun 1, 2004 | Meloxicam | FDA US | cancer not stated in this record | Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older | ORIGNDA021530 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jul 10, 2018 |
| health-canada-dpd |
| May 26, 2004 | Peginterferon Alfa-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEGASYS RBV (DIN 02253410) under ATC L03AB61 PEGINTERFERON ALFA-2A, COMBINATIONS. Indications are not published in… | DIN02253410 | withdrawnsource: Cancelled Post Marketsince Jul 10, 2018 | health-canada-dpd |
| May 19, 2004 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 2004-05-19 (see label) | SUPPLNDA020449 | approved | openfda |
| May 19, 2004 | Azacitidine | FDA US | cancer not stated in this record | Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed… | ORIGNDA050794 | approved | openfda |
| May 19, 2004 | Azacitidine | FDA US | Juvenile Myelomonocytic Leukemia | Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). | ORIGNDA050794 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Apr 28, 2004 | Mitotane | EMA EU | Adrenal Cortical Carcinoma | Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on… | centralisedEMEA/H/C/000521 | approved | ema |
| Apr 28, 2004 | Fludarabine | FDA US | Chronic Lymphocytic Leukemia | Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic… | ORIGANDA076661 | approved | openfda |
| Apr 26, 2004 | Bortezomib | EMA EU | cancer not stated in this record | Velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult… | centralisedEMEA/H/C/000539 | approved | ema |
| Apr 14, 2004 | Cladribine | EMA EU | Hairy Cell Leukemia | Litak is indicated for the treatment of hairy-cell leukaemia. | centralisedEMEA/H/C/000504 | approved | ema |
| Apr 12, 2004 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE TABLETS, USP (DIN 02182750) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02182750 | approvedsource: Marketed | health-canada-dpd |
| Mar 25, 2004 | Porfimer | EMA EU | cancer not stated in this record | Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus… | centralisedEMEA/H/C/000493 | withdrawnsince Apr 20, 2012 | ema |
| Mar 12, 2004 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NEULASTA (DIN 02249790) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02249790 | approvedsource: Marketed | health-canada-dpd |
| Mar 9, 2004 | Fulvestrant | EMA EU | Malignant Breast Neoplasm | Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in… | centralisedEMEA/H/C/000540 | approved | ema |
| Mar 8, 2004 | Cinacalcet | FDA US | cancer not stated in this record | Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. • Hypercalcemia in adult patients with… | ORIGNDA021688 | approved | openfda |
| Mar 8, 2004 | Cinacalcet | FDA US | Parathyroid Carcinoma | Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with… | ORIGNDA021688 | approved | openfda |