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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| 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 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 19, 1999 | Paclitaxel | EMA EU | cancer not stated in this record | Paxene is indicated for the treatment of patients with: advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal… |
| 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 |
|---|---|---|---|---|---|---|---|
| Mar 31, 1999 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBETRON READY TO USE SOLUTION (ALBUMIN(HUMAN)FREE) (6000000 IU/ML AND 200MG CAPSULES) (DIN 02239730) under ATC… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 22, 1999 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUTAMIDE-250 (DIN 02239388) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database… | DIN02239388 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 26, 1999 | Temozolomide | EMA EU | Glioblastoma | Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1998 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A - KIT (PWS+DILUENT) 5000000IU/VIAL (DIN 02223392) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not… | DIN |
| 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 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION USP (DIN 02182777) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN |
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/000216 |
| withdrawnsince Mar 1, 2010 |
| ema |
| Jul 12, 1999 | Interferon Alfacon-1 | Health Canada CA | cancer not stated in this record | Marketed in Canada as INFERGEN (DIN 02239832) under ATC L03AB09 INTERFERON ALFACON-1. Indications are not published in the Drug Product… | DIN02239832 | withdrawnsource: Cancelled Post Marketsince Oct 31, 2012 | health-canada-dpd |
| DIN02239730 |
| withdrawnsource: Cancelled Post Marketsince Oct 27, 2004 |
| health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Jul 23, 2009 |
| health-canada-dpd |
| Feb 11, 1999 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 1999-02-11 (see label) | SUPPLNDA020708 | 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 |
| centralisedEMEA/H/C/000229 |
| approved |
| ema |
| withdrawnsource: Cancelled Post Marketsince Jul 11, 2000 |
| health-canada-dpd |
| 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 | 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 |
| Dec 10, 1998 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02238675) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02238675 | withdrawnsource: Cancelled Post Marketsince Apr 12, 2021 | health-canada-dpd |
| Dec 10, 1998 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02238674) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02238674 | withdrawnsource: Cancelled Post Marketsince Aug 31, 2021 | health-canada-dpd |
| Dec 1, 1998 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUTAMIDE (DIN 02239045) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02239045 | withdrawnsource: Cancelled Post Marketsince Oct 25, 2016 | health-canada-dpd |
| Dec 1, 1998 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-TAMOXIFEN (DIN 02237460) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database… | DIN02237460 | withdrawnsource: Cancelled Post Marketsince Oct 28, 2016 | health-canada-dpd |
| Dec 1, 1998 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-TAMOXIFEN (DIN 02237459) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database… | DIN02237459 | withdrawnsource: Cancelled Post Marketsince Oct 28, 2016 | health-canada-dpd |
| 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 |
| Nov 25, 1998 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUOROURACIL INJECTION USP (DIN 02182742) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug… | DIN02182742 | withdrawnsource: Cancelled Post Marketsince Nov 27, 2020 | health-canada-dpd |
| Oct 13, 1998 | Pegaspargase | Health Canada CA | cancer not stated in this record | Marketed in Canada as ONCASPAR (DIN 02236849) under ATC L01XX24 PEGASPARGASE. Indications are not published in the Drug Product Database —… | DIN02236849 | withdrawnsource: Cancelled Post Marketsince Jan 2, 2004 | health-canada-dpd |
| Oct 8, 1998 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUTAMIDE (DIN 02238560) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02238560 | approvedsource: Marketed | health-canada-dpd |
| 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 |
| Sep 18, 1998 | Imiquimod | EMA EU | Superficial Basal Cell Carcinoma | Imiquimod cream is indicated for the topical treatment of : External genital and perianal warts (condylomata acuminata) in adults. Small… | centralisedEMEA/H/C/000179 | approved | ema |
| Sep 10, 1998 | Capecitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as XELODA (DIN 02238454) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database —… | DIN02238454 | withdrawnsource: Cancelled Post Marketsince Dec 7, 2022 | health-canada-dpd |
| Sep 10, 1998 | Capecitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as XELODA (DIN 02238453) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database —… | DIN02238453 | withdrawnsource: Cancelled Post Marketsince Dec 7, 2022 | health-canada-dpd |
| approved |
| openfda |
| Aug 19, 1998 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CAELYX (DIN 02238389) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product Database — see… | DIN02238389 | approvedsource: Marketed | health-canada-dpd |
| 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 |
| Jul 15, 1998 | Mitomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02237745) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug… | DIN02237745 | withdrawnsource: Cancelled Post Marketsince Feb 28, 2020 | health-canada-dpd |
| Jul 13, 1998 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION USP (DIN 02182955) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02182955 | approvedsource: Marketed | health-canada-dpd |
| Jun 19, 1998 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as AVONEX (DIN 02237770) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product… | DIN02237770 | withdrawnsource: Cancelled Post Marketsince Oct 30, 2010 | health-canada-dpd |
| Jun 2, 1998 | Rituximab | EMA EU | cancer not stated in this record | MabThera is indicated in adults for the following indications: Non Hodgkin’s lymphoma (NHL) MabThera is indicated for the treatment of… | centralisedEMEA/H/C/000165 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |