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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Sep 1, 2000 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2000-09-01 (see label) | SUPPLNDA020541 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 31, 2000 | Tretinoin | FDA US | cancer not stated in this record | (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 2000 | Bexarotene | FDA US | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 20, 2000 | Irinotecan | FDA US | cancer not stated in this record | Efficacy supplement 2000-04-20 (see label) | SUPPLNDA020571 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 10, 2000 | Bleomycin | FDA US | cancer not stated in this record | Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 29, 1999 | Bexarotene | FDA US | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 21, 1999 | Exemestane | FDA US | Malignant Breast Neoplasm | treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). | ORIGNDA020753 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 15, 1999 | Sirolimus | FDA US | cancer not stated in this record | Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 11, 1999 | Temozolomide | FDA US | Anaplastic Astrocytoma | Treatment of adults with refractory anaplastic astrocytoma. | ORIGNDA021029 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 1999 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 1999-06-28 (see label) | SUPPLNDA050718 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 11, 1999 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 1999-02-11 (see label) | SUPPLNDA020708 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1998 | Celecoxib | FDA US | cancer not stated in this record | Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older • Ankylosing… | ORIGNDA020998 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 30, 1998 | Thyrotropin Alfa | FDA US | Malignant Thyroid Gland Neoplasm | Limitations of Use : The effect of THYROGEN on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated. | ORIGBLA020898 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 22, 1998 | Irinotecan | FDA US | cancer not stated in this record | Efficacy supplement 1998-10-22 (see label) | SUPPLNDA020571 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 25, 1998 | Valrubicin | FDA US | cancer not stated in this record | VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 27, 1998 | Dacarbazine | FDA US | cancer not stated in this record | Dacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection is also… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 30, 1998 | Capecitabine | FDA US | cancer not stated in this record | Gastric, Esophageal, or Gastroesophageal Junction Cancer treatment of adults with unresectable or metastatic gastric, esophageal, or… | ORIG |
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.
| ORIGNDA021108 |
| approved |
| openfda |
| Aug 31, 2000 | Tretinoin | FDA US | Malignant Skin Neoplasm | Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin… | ORIGNDA021108 | approved | openfda |
| Aug 25, 2000 | Sirolimus | FDA US | cancer not stated in this record | - Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended… | ORIGNDA021110 | approved | openfda |
| ORIGNDA021056 |
| approved |
| openfda |
| Jun 15, 2000 | 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… | ORIGNDA020715 | approved | openfda |
| Apr 12, 2000 | Verteporfin | FDA US | cancer not stated in this record | VISUDYNE ® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal… | ORIGNDA021119 | approved | openfda |
| ORIGANDA065031 |
| approved |
| openfda |
| ORIGNDA021055 |
| approved |
| openfda |
| Dec 23, 1999 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 1999-12-23 (see label) | SUPPLNDA020449 | approved | openfda |
| Dec 7, 1999 | 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… | ORIGNDA020990 | approved | openfda |
| Dec 7, 1999 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1999-12-07 (see label) | SUPPLNDA019839 | approved | openfda |
| Dec 3, 1999 | Aminolevulinic Acid | FDA US | cancer not stated in this record | The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is… | ORIGNDA020965 | approved | openfda |
| openfda |
| Oct 21, 1999 | Exemestane | FDA US | Malignant Breast Neoplasm | adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of… | ORIGNDA020753 | approved | openfda |
| ORIGNDA021083 |
| approved |
| openfda |
| Sep 15, 1999 | Epirubicin | FDA US | Malignant Breast Neoplasm | ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of… | ORIGNDA050778 | approved | openfda |
| Aug 11, 1999 | Temozolomide | FDA US | Anaplastic Astrocytoma | Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. | ORIGNDA021029 | approved | openfda |
| Aug 11, 1999 | Temozolomide | FDA US | Anaplastic Astrocytoma | Anaplastic astrocytoma. | ORIGNDA021029 | approved | openfda |
| Aug 11, 1999 | Temozolomide | FDA US | Glioblastoma | Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. | ORIGNDA021029 | approved | openfda |
| Feb 2, 1999 | Alitretinoin | FDA US | AIDS-Related Kaposi Sarcoma | Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS).… | ORIGNDA020886 | approved | openfda |
| approved |
| openfda |
| Dec 22, 1998 | Porfimer | FDA US | cancer not stated in this record | Efficacy supplement 1998-12-22 (see label) | SUPPLNDA020451 | approved | openfda |
| Dec 18, 1998 | Ibuprofen | FDA US | cancer not stated in this record | USES temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches | ORIGNDA020944 | approved | openfda |
| Dec 17, 1998 | Prednisolone | FDA US | cancer not stated in this record | Efficacy supplement 1998-12-17 (see label) | SUPPLNDA019157 | approved | openfda |
| Dec 16, 1998 | Anagrelide | FDA US | cancer not stated in this record | Efficacy supplement 1998-12-16 (see label) | SUPPLNDA020333 | approved | openfda |
| approved |
| openfda |
| Nov 30, 1998 | Thyrotropin Alfa | FDA US | Differentiated Thyroid Gland Carcinoma | Limitations of Use : THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone… | ORIGBLA020898 | approved | openfda |
| Nov 30, 1998 | Thyrotropin Alfa | FDA US | Differentiated Thyroid Gland Carcinoma | Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg)… | ORIGBLA020898 | approved | openfda |
| Nov 30, 1998 | Topotecan | FDA US | cancer not stated in this record | Efficacy supplement 1998-11-30 (see label) | SUPPLNDA020671 | approved | openfda |
| ORIGNDA020892 |
| approved |
| openfda |
| Sep 25, 1998 | Trastuzumab | FDA US | cancer not stated in this record | Select patients for therapy based on an FDA-authorized companion diagnostic for Herceptin ( 1 , 2.2 ). | ORIGBLA103792 | approved | openfda |
| Sep 25, 1998 | Trastuzumab | FDA US | Gastroesophageal Junction Adenocarcinoma | The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. | ORIGBLA103792 | approved | openfda |
| Sep 25, 1998 | Trastuzumab | FDA US | Malignant Breast Neoplasm | The treatment of HER2-overexpressing breast cancer. | ORIGBLA103792 | approved | openfda |
| approved |
| openfda |
| Jul 27, 1998 | Goserelin | FDA US | cancer not stated in this record | Efficacy supplement 1998-07-27 (see label) | SUPPLNDA019726 | approved | openfda |
| Jul 16, 1998 | Thalidomide | FDA US | cancer not stated in this record | THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).… | ORIGNDA020785 | approved | openfda |
| Jul 16, 1998 | Thalidomide | FDA US | Multiple Myeloma | THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). | ORIGNDA020785 | approved | openfda |
| approved |
| openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Pancreatic Adenocarcinoma | Pancreatic Cancer adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Gastroesophageal Junction Adenocarcinoma | treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior… | ORIGNDA020896 | approved | openfda |