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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Jun 17, 2010 | Nilotinib | FDA US | cancer not stated in this record | Efficacy supplement 2010-06-17 (see label) | SUPPLNDA022068 | approved | openfda |
| Jun 17, 2010 | Cabazitaxel | FDA US | Castration-Resistant Prostate Carcinoma | JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer… | ORIGNDA201023 | approved | openfda |
| Jun 14, 2010 | Pazopanib | EMA EU | cancer not stated in this record | Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for… | centralisedEMEA/H/C/001141 | approved | ema |
| Jun 9, 2010 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the… | centralisedEMEA/H/C/001192 | approved | ema |
| Jun 7, 2010 | Filgrastim | EMA EU | cancer not stated in this record | Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/001142 | approved | ema |
| Jun 1, 2010 | Denosumab | FDA US | cancer not stated in this record | of postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for… | ORIGBLA125320 | approved | openfda |
| Jun 1, 2010 | Denosumab | FDA US | Malignant Breast Neoplasm | to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer | ORIGBLA125320 | approved | openfda |
| Jun 1, 2010 | Denosumab | FDA US | Malignant Prostate Neoplasm | to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer | ORIGBLA125320 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2010 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 25, 2010 | Imiquimod | FDA US | cancer not stated in this record | ZYCLARA 2.5% and 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 25, 2010 | Hydroxyurea | Health Canada CA | cancer not stated in this record | Marketed in Canada as HYDROXYUREA (DIN 02343096) under ATC L01XX05 HYDROXYCARBAMIDE. Indications are not published in the Drug Product… | DIN02343096 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 30, 2009 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2009-12-30 (see label) | SUPPLNDA021602 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 24, 2009 | Degarelix | Health Canada CA | cancer not stated in this record | Marketed in Canada as FIRMAGON (DIN 02337037) under ATC L02BX02 DEGARELIX. Indications are not published in the Drug Product Database — see… | DIN02337037 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 26, 2009 | Ofatumumab | FDA US | cancer not stated in this record | KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… |
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.
| centralisedEMEA/H/C/001120 |
| approved |
| ema |
| May 13, 2010 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 2010-05-13 (see label) | SUPPLNDA020449 | approved | openfda |
| May 10, 2010 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with… | centralisedEMEA/H/C/001074 | withdrawnsince May 25, 2012 | ema |
| May 5, 2010 | Interferon Beta-1b | Health Canada CA | cancer not stated in this record | Marketed in Canada as EXTAVIA (DIN 02337819) under ATC L03AB08 INTERFERON BETA-1B. Indications are not published in the Drug Product… | DIN02337819 | withdrawnsource: Cancelled Post Marketsince Mar 8, 2022 | health-canada-dpd |
| May 5, 2010 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ACH-BICALUTAMIDE (DIN 02325985) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02325985 | approvedsource: Marketed | health-canada-dpd |
| May 3, 2010 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as ACH-LETROZOLE (DIN 02338459) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database… | DIN02338459 | approvedsource: Marketed | health-canada-dpd |
| Apr 28, 2010 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as LETROZOLE (DIN 02348969) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database —… | DIN02348969 | withdrawnsource: Cancelled Post Marketsince Jun 18, 2018 | health-canada-dpd |
| Apr 28, 2010 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as LETROZOLE (DIN 02347997) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database —… | DIN02347997 | withdrawnsource: Cancelled Post Marketsince Dec 10, 2013 | health-canada-dpd |
| Apr 28, 2010 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as MED-LETROZOLE (DIN 02322315) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database… | DIN02322315 | withdrawnsource: Dormantsince May 25, 2018 | health-canada-dpd |
| Apr 28, 2010 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-LETROZOLE (DIN 02309114) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database… | DIN02309114 | approvedsource: Marketed | health-canada-dpd |
| Apr 27, 2010 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ LETROZOLE (DIN 02344815) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product… | DIN02344815 | approvedsource: Marketed | health-canada-dpd |
| Apr 26, 2010 | Temsirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2010-04-26 (see label) | SUPPLNDA022088 | approved | openfda |
| Apr 20, 2010 | Everolimus | FDA US | cancer not stated in this record | Kidney Transplant : at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids… | ORIGNDA021560 | approved | openfda |
| Apr 19, 2010 | Ofatumumab | EMA EU | Chronic Lymphocytic Leukemia | Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the… | centralisedEMEA/H/C/001131 | withdrawnsince Feb 28, 2019 | ema |
| Apr 13, 2010 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDARUBICIN HYDROCHLORIDE INJECTION (DIN 02337584) under ATC L01DB06 IDARUBICIN. Indications are not published in the… | DIN02337584 | withdrawnsource: Cancelled Post Marketsince Oct 7, 2021 | health-canada-dpd |
| ORIGNDA022483 |
| approved |
| openfda |
| Mar 15, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… | centralisedEMEA/H/C/001128 | withdrawnsince Sep 15, 2022 | ema |
| Mar 15, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… | centralisedEMEA/H/C/001127 | withdrawn | ema |
| Mar 15, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… | centralisedEMEA/H/C/001125 | approved | ema |
| Mar 15, 2010 | Thiotepa | EMA EU | cancer not stated in this record | TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as… | centralisedEMEA/H/C/001046 | approved | ema |
| Mar 12, 2010 | Aminolevulinic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2010-03-12 (see label) | SUPPLNDA020965 | approved | openfda |
| Mar 10, 2010 | Triptorelin | FDA US | Malignant Prostate Neoplasm | TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing… | ORIGNDA022437 | approved | openfda |
| Mar 2, 2010 | Letrozole | FDA US | cancer not stated in this record | Efficacy supplement 2010-03-02 (see label) | SUPPLNDA020726 | approved | openfda |
| Mar 2, 2010 | Letrozole | FDA US | cancer not stated in this record | Efficacy supplement 2010-03-02 (see label) | SUPPLNDA020726 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jul 31, 2017 |
| health-canada-dpd |
| Feb 18, 2010 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2010-02-18 (see label) | SUPPLBLA103705 | approved | openfda |
| Feb 18, 2010 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2010-02-18 (see label) | SUPPLBLA103705 | approved | openfda |
| Feb 10, 2010 | Clofarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CLOLAR (DIN 02330407) under ATC L01BB06 CLOFARABINE. Indications are not published in the Drug Product Database — see… | DIN02330407 | approvedsource: Marketed | health-canada-dpd |
| Jan 28, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… | centralisedEMEA/H/C/001126 | approved | ema |
| Jan 26, 2010 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:… | centralisedEMEA/H/C/001107 | withdrawn | ema |
| Jan 25, 2010 | Temozolomide | EMA EU | Glioblastoma | Temomedac hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with… | centralisedEMEA/H/C/001124 | approved | ema |
| Jan 4, 2010 | Azacitidine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VIDAZA (DIN 02336707) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see… | DIN02336707 | approvedsource: Marketed | health-canada-dpd |
| Dec 30, 2009 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2009-12-30 (see label) | SUPPLNDA021602 | approved | openfda |
| Dec 10, 2009 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02321262) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02321262 | withdrawnsource: Cancelled Post Marketsince Feb 1, 2016 | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 24, 2009 | Degarelix | Health Canada CA | cancer not stated in this record | Marketed in Canada as FIRMAGON (DIN 02337029) under ATC L02BX02 DEGARELIX. Indications are not published in the Drug Product Database — see… | DIN02337029 | approvedsource: Marketed | health-canada-dpd |
| Nov 5, 2009 | Romidepsin | FDA US | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic… | ORIGNDA022393 | approved | openfda |
| ORIGBLA125326 |
| approved |
| openfda |
| Oct 19, 2009 | Pazopanib | FDA US | Soft Tissue Sarcoma | Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal… | ORIGNDA022465 | approved | openfda |