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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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
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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 |
|---|---|---|---|---|---|---|---|
| Sep 24, 2009 | Pralatrexate | FDA US | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colorectal Neoplasm | treatment of advanced colorectal cancer. ( 1 ) | ORIGANDA078813 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2009 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2009-07-31 (see label) | SUPPLBLA125085 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 17, 2009 | Dexamethasone | FDA US | cancer not stated in this record | The treatment of non-infectious uveitis affecting the posterior segment of the eye • The treatment of diabetic macular edema | ORIGNDA022315 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2009 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-29 (see label) | SUPPLNDA021817 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 30, 2009 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2009-04-30 (see label) | SUPPLNDA020541 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 30, 2009 | Everolimus | FDA US | cancer not stated in this record | Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. • AFINITOR and AFINITOR DISPERZ are… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 27, 2009 | Glatiramer | FDA US | cancer not stated in this record | Efficacy supplement 2009-02-27 (see label) | SUPPLNDA020622 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 20, 2008 | 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 26, 2008 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-26 (see label) | SUPPLNDA021462 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 20, 2008 | Azacitidine | FDA US | cancer not stated in this record | Efficacy supplement 2008-08-20 (see label) | SUPPLNDA050794 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2008 | Verteporfin | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-30 (see label) | SUPPLNDA021119 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 22, 2008 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-05-22 (see label) | SUPPLBLA103792 | 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.
| ORIGNDA022468 |
| approved |
| openfda |
| Sep 23, 2009 | Vorinostat | FDA US | cancer not stated in this record | Efficacy supplement 2009-09-23 (see label) | SUPPLNDA021991 | approved | openfda |
| Sep 3, 2009 | Ibritumomab Tiuxetan | FDA US | cancer not stated in this record | Efficacy supplement 2009-09-03 (see label) | SUPPLBLA125019 | approved | openfda |
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colon Neoplasm | adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 ) | ORIGANDA078813 | approved | openfda |
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colorectal Neoplasm | treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and… | ORIGANDA078813 | approved | openfda |
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colon Neoplasm | adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. | ORIGANDA078813 | approved | openfda |
| Jul 22, 2009 | Vinorelbine | FDA US | Lung Non-Small Cell Carcinoma | Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic… | ORIGANDA078011 | approved | openfda |
| Jul 2, 2009 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2009-07-02 (see label) | SUPPLNDA021462 | approved | openfda |
| openfda |
| Jun 17, 2009 | Dexamethasone | FDA US | Conventional Osteosarcoma | The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) | ORIGNDA022315 | approved | openfda |
| Jun 11, 2009 | Ibuprofen | FDA US | cancer not stated in this record | CALDOLOR is indicated in adults and pediatric patients aged 3 months and older for the: management of mild to moderate pain, including… | ORIGNDA022348 | approved | openfda |
| Jun 9, 2009 | Melphalan | FDA US | Multiple Myeloma | Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is… | ORIGANDA090270 | approved | openfda |
| May 27, 2009 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-27 (see label) | SUPPLNDA021588 | approved | openfda |
| May 27, 2009 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-27 (see label) | SUPPLNDA021588 | approved | openfda |
| May 21, 2009 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-21 (see label) | SUPPLNDA021986 | approved | openfda |
| May 5, 2009 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-05 (see label) | SUPPLBLA125085 | approved | openfda |
| ORIGNDA022334 |
| approved |
| openfda |
| Mar 30, 2009 | Everolimus | FDA US | Renal Cell Carcinoma | Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. | ORIGNDA022334 | approved | openfda |
| Mar 30, 2009 | Everolimus | FDA US | Primitive Neuroectodermal Tumor | Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional… | ORIGNDA022334 | approved | openfda |
| Mar 30, 2009 | Everolimus | FDA US | Malignant Breast Neoplasm | Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of… | ORIGNDA022334 | approved | openfda |
| Mar 13, 2009 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2009-03-13 (see label) | SUPPLNDA021817 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Anaplastic Astrocytoma | Treatment of adults with refractory anaplastic astrocytoma. | ORIGNDA022277 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Anaplastic Astrocytoma | Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. | ORIGNDA022277 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Anaplastic Astrocytoma | Anaplastic astrocytoma. | ORIGNDA022277 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Glioblastoma | Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. | ORIGNDA022277 | approved | openfda |
| Dec 24, 2008 | Degarelix | FDA US | Malignant Prostate Neoplasm | FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for… | ORIGNDA022201 | approved | openfda |
| Dec 19, 2008 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2008-12-19 (see label) | SUPPLNDA021817 | approved | openfda |
| Dec 19, 2008 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2008-12-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Dec 19, 2008 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2008-12-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Dec 15, 2008 | Plerixafor | FDA US | Multiple Myeloma | Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and… | ORIGNDA022311 | approved | openfda |
| ORIGNDA021591 |
| approved |
| openfda |
| Sep 26, 2008 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-26 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 26, 2008 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-26 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 8, 2008 | Porfimer | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-08 (see label) | SUPPLNDA020451 | approved | openfda |
| Jun 23, 2008 | Panitumumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-23 (see label) | SUPPLBLA125147 | approved | openfda |
| Jun 20, 2008 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-20 (see label) | SUPPLNDA021602 | approved | openfda |
| Jun 10, 2008 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-10 (see label) | SUPPLNDA050718 | approved | openfda |
| Jun 3, 2008 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-03 (see label) | SUPPLNDA021817 | approved | openfda |
| May 22, 2008 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-05-22 (see label) | SUPPLBLA103792 | approved | openfda |