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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
183
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 48 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 15 hours 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 |
|---|---|---|---|---|---|---|---|
| May 14, 1996 | Docetaxel | FDA US | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with… | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Malignant Breast Neoplasm | Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and… | ORIGNDA020449 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 11, 1996 | Goserelin | FDA US | Prostate Carcinoma | Use as palliative treatment of advanced carcinoma of the prostate | ORIGNDA020578 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 28, 1995 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1995-12-28 (see label) | SUPPLBLA103353 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 17, 1995 | Doxorubicin | FDA US | Multiple Myeloma | Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one… | ORIGNDA050718 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 4, 1995 | Bicalutamide | FDA US | Prostate Carcinoma | 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 29, 1995 | Prednisolone | FDA US | cancer not stated in this record | Efficacy supplement 1995-08-29 (see label) | SUPPLNDA017469 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 16, 1995 | Ibuprofen | FDA US | cancer not stated in this record | Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever | ORIGNDA020516 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 19, 1994 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1994-12-19 (see label) | SUPPLBLA103353 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 15, 1994 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1994-06-15 (see label) | SUPPLBLA103353 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 1, 1994 | Pegaspargase | FDA US | Acute Lymphoblastic Leukemia | Acute lymphoblastic leukemia and hypersensitivity to asparaginase | ORIGBLA103411 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 29, 1993 | Pentostatin | FDA US | cancer not stated in this record | Efficacy supplement 1993-09-29 (see label) | SUPPLNDA020122 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 23, 1993 | Interferon Beta-1b | FDA US | cancer not stated in this record | BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 5, 1992 | Aldesleukin | FDA US | Melanoma | The treatment of adults with metastatic melanoma. | ORIGBLA103293 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 1992 | Amphotericin B | FDA US | cancer not stated in this record | INDICATIONS & USAGE Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 30, 1991 | Sertraline | FDA US | cancer not stated in this record | Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 11, 1991 | Pentostatin | FDA US | Hairy Cell Leukemia | NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 20, 1991 | Filgrastim | FDA US | cancer not stated in this record | NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 22, 1990 | Leuprolide | FDA US | cancer not stated in this record | Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. • In combination with a… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 4, 1990 | Cytarabine | FDA US | cancer not stated in this record | Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 29, 1989 | Goserelin | FDA US | cancer not stated in this record | The management of endometriosis • Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding | ORIGNDA019726 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 26, 1989 | Leuprolide | FDA US | Malignant Prostate Neoplasm | LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 16, 1988 | Tretinoin | FDA US | cancer not stated in this record | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this… | ORIGNDA019049 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 8, 1988 | Megestrol | FDA US | Breast Carcinoma | Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 19, 1988 | Vincristine | FDA US | cancer not stated in this record | Vincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 3, 1988 | Sulindac | FDA US | cancer not stated in this record | Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 23, 1987 | Doxorubicin | FDA US | cancer not stated in this record | for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 14, 1987 | Ifosfamide | FDA US | Malignant Testicular Neoplasm | Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line… |
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 11, 1996 | Goserelin | FDA US | Prostate Carcinoma | Use in combination with flutamide for the management of locally confined carcinoma of the prostate | ORIGNDA020578 | approved | openfda |
| Dec 27, 1995 | Anastrozole | FDA US | Malignant Breast Neoplasm | Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative… | ORIGNDA020541 | approved | openfda |
| Dec 27, 1995 | Anastrozole | FDA US | Malignant Breast Neoplasm | First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic… | ORIGNDA020541 | approved | openfda |
| Dec 27, 1995 | Anastrozole | FDA US | Malignant Breast Neoplasm | Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer | ORIGNDA020541 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | cancer not stated in this record | Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy | ORIGNDA020451 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | Lung Non-Small Cell Carcinoma | Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated… | ORIGNDA020451 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | Malignant Esophageal Neoplasm | Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in… | ORIGNDA020451 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | Malignant Esophageal Neoplasm | Esophageal Cancer | ORIGNDA020451 | approved | openfda |
| Dec 22, 1995 | Leuprolide | FDA US | Malignant Prostate Neoplasm | LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month… | ORIGNDA020517 | approved | openfda |
| openfda |
| Nov 17, 1995 | Doxorubicin | FDA US | AIDS-Related Kaposi Sarcoma | AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy | ORIGNDA050718 | approved | openfda |
| Nov 17, 1995 | Doxorubicin | FDA US | Malignant Ovarian Neoplasm | Ovarian cancer: After failure of platinum-based chemotherapy | ORIGNDA050718 | approved | openfda |
| ORIGNDA020498 |
| approved |
| openfda |
| openfda |
| Feb 1, 1994 | Pegaspargase | FDA US | Acute Lymphoblastic Leukemia | First-line acute lymphoblastic leukemia | ORIGBLA103411 | approved | openfda |
| ORIGBLA103471 |
| approved |
| openfda |
| Apr 16, 1993 | Leuprolide | FDA US | Conventional Osteosarcoma | LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP). LUPRON DEPOT-PED is a… | ORIGNDA020263 | approved | openfda |
| May 5, 1992 | Aldesleukin | FDA US | Renal Cell Carcinoma | The treatment of adults with metastatic renal cell carcinoma. | ORIGBLA103293 | approved | openfda |
| ORIGANDA063206 |
| approved |
| openfda |
| ORIGNDA019839 |
| approved |
| openfda |
| ORIGNDA020122 |
| approved |
| openfda |
| ORIGBLA103353 |
| approved |
| openfda |
| Feb 20, 1991 | Filgrastim | FDA US | Acute Myeloid Leukemia | Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients… | ORIGBLA103353 | approved | openfda |
| ORIGNDA020011 |
| approved |
| openfda |
| ORIGANDA071868 |
| approved |
| openfda |
| openfda |
| Dec 29, 1989 | Goserelin | FDA US | Malignant Breast Neoplasm | Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women | ORIGNDA019726 | approved | openfda |
| Dec 29, 1989 | Goserelin | FDA US | Prostate Carcinoma | Palliative treatment of advanced carcinoma of the prostate | ORIGNDA019726 | approved | openfda |
| Dec 29, 1989 | Goserelin | FDA US | Prostate Carcinoma | Use in combination with flutamide for the management of locally confined carcinoma of the prostate | ORIGNDA019726 | approved | openfda |
| ORIGNDA019732 |
| approved |
| openfda |
| approved |
| openfda |
| ORIGANDA072423 |
| approved |
| openfda |
| ORIGANDA071484 |
| approved |
| openfda |
| Apr 7, 1988 | Methotrexate | FDA US | cancer not stated in this record | Efficacy supplement 1988-04-07 (see label) | SUPPLNDA011719 | approved | openfda |
| ORIGANDA071795 |
| approved |
| openfda |
| ORIGNDA050629 |
| approved |
| openfda |
| Dec 23, 1987 | Doxorubicin | FDA US | Malignant Breast Neoplasm | as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of… | ORIGNDA050629 | approved | openfda |
| ORIGNDA019763 |
| approved |
| openfda |