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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Feb 7, 2003 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2003-02-07 (see label) | SUPPLNDA019839 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2003 | Interferon Beta-1a | FDA US | cancer not stated in this record | Efficacy supplement 2003-01-31 (see label) | SUPPLBLA103628 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 3, 2002 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | Efficacy supplement 2002-12-03 (see label) | SUPPLBLA103964 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 16, 2002 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | PEGASYS is an inducer of the innate immune response indicated for the treatment of Chronic Hepatitis C (CHC) • Adult Patients: In… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 20, 2002 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2002-09-20 (see label) | SUPPLNDA020990 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 28, 2002 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2002-08-28 (see label) | SUPPLBLA103792 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 24, 2002 | Leuprolide | FDA US | Malignant Prostate Neoplasm | VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 16, 2002 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2002-05-16 (see label) | SUPPLNDA020990 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease… | ORIGNDA021344 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 7, 2002 | Interferon Beta-1a | FDA US | cancer not stated in this record | REBIF 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 |
|---|---|---|---|---|---|---|---|
| Feb 19, 2002 | Ibritumomab Tiuxetan | FDA US | cancer not stated in this record | . previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy | ORIGBLA125019 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2002 | Pegfilgrastim | FDA US | cancer not stated in this record | Neulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 11, 2001 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2001-12-11 (see label) | SUPPLBLA103792 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 21, 2001 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2001-09-21 (see label) | SUPPLNDA020708 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 22, 2001 | Verteporfin | FDA US | cancer not stated in this record | Efficacy supplement 2001-08-22 (see label) | SUPPLNDA021119 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2001 | 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… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2001 | Irbesartan | FDA US | cancer not stated in this record | Efficacy supplement 2001-05-26 (see label) | SUPPLNDA020757 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 30, 2001 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2001-04-30 (see label) | SUPPLNDA020896 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 25, 2000 | Arsenic Trioxide | FDA US | cancer not stated in this record | For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline… |
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 17, 2003 | Letrozole | FDA US | cancer not stated in this record | Efficacy supplement 2003-01-17 (see label) | SUPPLNDA020726 | approved | openfda |
| Nov 12, 2002 | Interferon Beta-1a | FDA US | cancer not stated in this record | Efficacy supplement 2002-11-12 (see label) | SUPPLBLA103628 | approved | openfda |
| ORIGBLA103964 |
| approved |
| openfda |
| Sep 20, 2002 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2002-09-20 (see label) | SUPPLNDA020990 | approved | openfda |
| Sep 20, 2002 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2002-09-20 (see label) | SUPPLNDA019839 | approved | openfda |
| Sep 20, 2002 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2002-09-20 (see label) | SUPPLNDA019839 | approved | openfda |
| Sep 17, 2002 | Irbesartan | FDA US | cancer not stated in this record | Efficacy supplement 2002-09-17 (see label) | SUPPLNDA020757 | approved | openfda |
| Sep 5, 2002 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2002-09-05 (see label) | SUPPLNDA020541 | approved | openfda |
| approved |
| openfda |
| May 16, 2002 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2002-05-16 (see label) | SUPPLNDA019839 | approved | openfda |
| May 10, 2002 | Tretinoin | FDA US | cancer not stated in this record | Efficacy supplement 2002-05-10 (see label) | SUPPLNDA020475 | approved | openfda |
| approved |
| openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not… | ORIGNDA021344 | approved | openfda |
| ORIGBLA103780 |
| approved |
| openfda |
| openfda |
| Feb 19, 2002 | Ibritumomab Tiuxetan | FDA US | B-Cell Non-Hodgkin Lymphoma | relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) | ORIGBLA125019 | approved | openfda |
| ORIGBLA125031 |
| approved |
| openfda |
| Jan 23, 2002 | Leuprolide | FDA US | Malignant Prostate Neoplasm | VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated… | ORIGNDA021343 | approved | openfda |
| Oct 12, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-10-12 (see label) | SUPPLNDA020990 | approved | openfda |
| Oct 12, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-10-12 (see label) | SUPPLNDA019839 | approved | openfda |
| Sep 21, 2001 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2001-09-21 (see label) | SUPPLNDA020011 | approved | openfda |
| Sep 18, 2001 | Flutamide | FDA US | Prostate Carcinoma | Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D… | ORIGANDA075298 | approved | openfda |
| Sep 7, 2001 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2001-09-07 (see label) | SUPPLNDA020896 | approved | openfda |
| Aug 6, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-08-06 (see label) | SUPPLNDA020990 | approved | openfda |
| Aug 6, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-08-06 (see label) | SUPPLNDA019839 | approved | openfda |
| approved |
| openfda |
| May 7, 2001 | Alemtuzumab | FDA US | Chronic Lymphocytic Leukemia | CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed… | ORIGBLA103948 | approved | openfda |
| ORIGNDA021248 |
| approved |
| openfda |
| Sep 25, 2000 | Arsenic Trioxide | FDA US | Acute Promyelocytic Leukemia | In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is… | ORIGNDA021248 | approved | openfda |