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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
179
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 44 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated yesterdaySource 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 26, 2004 | Bevacizumab | FDA US | Malignant Colon Neoplasm | Limitations of Use : Avastin is not indicated for adjuvant treatment of colon cancer. | ORIGBLA125085 | approved | openfda |
| Feb 26, 2004 | Bevacizumab | FDA US | Malignant Colorectal Neoplasm | Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for… | ORIGBLA125085 | approved | openfda |
| Feb 26, 2004 | Bevacizumab | FDA US | Malignant Colorectal Neoplasm | Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. | ORIGBLA125085 | approved | openfda |
| Feb 12, 2004 | Cetuximab | FDA US | Malignant Colorectal Neoplasm | Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests… | ORIGBLA125084 | approved | openfda |
| Feb 12, 2004 | Cetuximab | FDA US | Malignant Colorectal Neoplasm | Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with… | ORIGBLA125084 | approved | openfda |
| Feb 12, 2004 | Cetuximab | FDA US | Head and Neck Squamous Cell Carcinoma | Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. | ORIGBLA125084 | approved | openfda |
| Feb 12, 2004 | Cetuximab | FDA US | Head and Neck Squamous Cell Carcinoma | Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with… | ORIGBLA125084 | approved | openfda |
| Feb 12, 2004 | Cetuximab | FDA US | Head and Neck Squamous Cell Carcinoma | Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. | ORIGBLA125084 | approved | openfda |
| Feb 4, 2004 | Pemetrexed | FDA US | Pleural Malignant Mesothelioma | initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are… | ORIGNDA021462 | approved | openfda |
| Feb 4, 2004 | Pemetrexed | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | ORIGNDA021462 | approved | openfda |
| Feb 4, 2004 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | ORIGNDA021462 | approved | openfda |
| Feb 4, 2004 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not… | ORIGNDA021462 | approved | openfda |
| Feb 4, 2004 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. | ORIGNDA021462 | approved | openfda |
| Feb 4, 2004 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small… | ORIGNDA021462 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 24, 2003 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2003-12-24 (see label) | SUPPLNDA021344 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 16, 2003 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2003-09-16 (see label) | SUPPLNDA020990 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 26, 2003 | Hydroxyurea | FDA US | cancer not stated in this record | Efficacy supplement 2003-06-26 (see label) | SUPPLNDA016295 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 20, 2003 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2003-05-20 (see label) | SUPPLNDA021588 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 18, 2003 | Imatinib Mesylate | FDA US | cancer not stated in this record | Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. •… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 14, 2003 | Interferon Beta-1b | FDA US | cancer not stated in this record | Efficacy supplement 2003-03-14 (see label) | SUPPLBLA103471 | 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.
| Dec 8, 2003 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2003-12-08 (see label) | SUPPLNDA021588 | approved | openfda |
| Dec 8, 2003 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2003-12-08 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 16, 2003 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2003-09-16 (see label) | SUPPLNDA019839 | approved | openfda |
| Sep 11, 2003 | Metformin | FDA US | cancer not stated in this record | RIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and… | ORIGNDA021591 | approved | openfda |
| May 20, 2003 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2003-05-20 (see label) | SUPPLNDA021588 | approved | openfda |
| May 13, 2003 | Bortezomib | FDA US | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | ORIGNDA021602 | approved | openfda |
| May 13, 2003 | Bortezomib | FDA US | Multiple Myeloma | treatment of adult patients with multiple myeloma | ORIGNDA021602 | approved | openfda |
| May 8, 2003 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 2003-05-08 (see label) | SUPPLNDA050629 | approved | openfda |
| May 2, 2003 | Interferon Beta-1a | FDA US | cancer not stated in this record | Efficacy supplement 2003-05-02 (see label) | SUPPLBLA103780 | approved | openfda |
| ORIGNDA021588 |
| approved |
| openfda |
| Apr 18, 2003 | Imatinib Mesylate | FDA US | Malignant Gastrointestinal Stromal Tumor | Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib Mesylate | FDA US | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib Mesylate | FDA US | Aggressive Systemic Mastocytosis | Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib Mesylate | FDA US | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR)… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib Mesylate | FDA US | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib Mesylate | FDA US | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | cancer not stated in this record | Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. •… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | Malignant Gastrointestinal Stromal Tumor | Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | Aggressive Systemic Mastocytosis | Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR)… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with… | ORIGNDA021588 | approved | openfda |
| Apr 18, 2003 | Imatinib | FDA US | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | ORIGNDA021588 | approved | openfda |
| Apr 11, 2003 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2003-04-11 (see label) | SUPPLNDA021083 | approved | openfda |
| Apr 11, 2003 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2003-04-11 (see label) | SUPPLNDA021110 | approved | openfda |
| Mar 11, 2003 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2003-03-11 (see label) | SUPPLNDA021029 | approved | openfda |
| Feb 26, 2003 | Letrozole | FDA US | cancer not stated in this record | Efficacy supplement 2003-02-26 (see label) | SUPPLNDA020726 | approved | openfda |
| Feb 25, 2003 | Carmustine | FDA US | cancer not stated in this record | Efficacy supplement 2003-02-25 (see label) | SUPPLNDA020637 | approved | openfda |
| Feb 13, 2003 | 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… | ORIGNDA021488 | approved | openfda |
| Feb 7, 2003 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2003-02-07 (see label) | SUPPLNDA020990 | approved | openfda |