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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 2 days agoSource updated unknown3 authority · jurisdiction pairs ingested
Feed
Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 20, 2008 | Bendamustine | FDA US | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a… | ORIGNDA022249 | approved | openfda |
| Mar 20, 2008 | Bendamustine | FDA US | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | ORIGNDA022249 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 22, 2008 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-02-22 (see label) | SUPPLBLA125085 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 14, 2007 | Thyrotropin Alfa | FDA US | cancer not stated in this record | Efficacy supplement 2007-12-14 (see label) | SUPPLBLA020898 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 29, 2007 | Nilotinib | FDA US | cancer not stated in this record | Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid… | ORIGNDA022068 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 26, 2007 | Tretinoin | FDA US | cancer not stated in this record | Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne… | ORIGNDA022070 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 2007 | Temsirolimus | FDA US | Renal Cell Carcinoma | TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of… | ORIGNDA022088 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 16, 2007 | Zoledronic Acid | FDA US | cancer not stated in this record | Treatment and prevention of postmenopausal osteoporosis • Treatment to increase bone mass in men with osteoporosis • Treatment and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 13, 2007 | Lapatinib | FDA US | Malignant Breast Neoplasm | TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 15, 2007 | Paclitaxel | FDA US | cancer not stated in this record | Efficacy supplement 2007-02-15 (see label) | SUPPLNDA021660 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 16, 2006 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2006-11-16 (see label) | SUPPLBLA103792 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 20, 2006 | Interferon Beta-1b | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-20 (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.
| Jan 18, 2008 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-18 (see label) | SUPPLBLA103792 | approved | openfda |
| Jan 14, 2008 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-14 (see label) | SUPPLNDA021083 | approved | openfda |
| Jan 14, 2008 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-14 (see label) | SUPPLNDA021110 | approved | openfda |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 8, 2007 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-08 (see label) | SUPPLNDA021986 | approved | openfda |
| Nov 8, 2007 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-08 (see label) | SUPPLNDA021986 | approved | openfda |
| approved |
| openfda |
| Oct 29, 2007 | Nilotinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase… | ORIGNDA022068 | approved | openfda |
| Oct 29, 2007 | Nilotinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included… | ORIGNDA022068 | approved | openfda |
| Oct 11, 2007 | Topotecan | FDA US | Lung Small Cell Carcinoma | HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial… | ORIGNDA020981 | approved | openfda |
| Oct 10, 2007 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2007-10-10 (see label) | SUPPLNDA021602 | approved | openfda |
| Oct 2, 2007 | Cetuximab | FDA US | cancer not stated in this record | Efficacy supplement 2007-10-02 (see label) | SUPPLBLA125084 | approved | openfda |
| Sep 19, 2007 | Alemtuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2007-09-19 (see label) | SUPPLBLA103948 | approved | openfda |
| Sep 13, 2007 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-09-13 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 13, 2007 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-09-13 (see label) | SUPPLNDA021588 | approved | openfda |
| openfda |
| approved |
| openfda |
| May 17, 2007 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 2007-05-17 (see label) | SUPPLNDA050718 | approved | openfda |
| May 3, 2007 | Histrelin | FDA US | Conventional Osteosarcoma | SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).… | ORIGNDA022058 | approved | openfda |
| ORIGNDA021817 |
| approved |
| openfda |
| Apr 16, 2007 | Zoledronic Acid | FDA US | Paget Disease | Treatment of Paget’s disease of bone in men and women | ORIGNDA021817 | approved | openfda |
| ORIGNDA022059 |
| approved |
| openfda |
| Feb 2, 2007 | Sunitinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-02-02 (see label) | SUPPLNDA021938 | approved | openfda |
| Feb 2, 2007 | Sunitinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-02-02 (see label) | SUPPLNDA021938 | approved | openfda |
| Feb 2, 2007 | Sunitinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-02-02 (see label) | SUPPLNDA021938 | approved | openfda |
| Jan 30, 2007 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2007-01-30 (see label) | SUPPLNDA021110 | approved | openfda |
| Jan 26, 2007 | Azacitidine | FDA US | cancer not stated in this record | Efficacy supplement 2007-01-26 (see label) | SUPPLNDA050794 | approved | openfda |
| Dec 8, 2006 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2006-12-08 (see label) | SUPPLNDA021602 | approved | openfda |
| Oct 19, 2006 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |