| Enzalutamide | CA Health Canada | — | Marketed in Canada as PMS-ENZALUTAMIDE (DIN 02570831) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Enzalutamide | EU EMA | Castration-Resistant Prostate Carcinoma | Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | approved | Aug 22, 2024 | ema |
| Enzalutamide | EU EMA | Castration-Resistant Prostate Carcinoma | Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | approved | Jun 21, 2013 | ema |
| Enzalutamide | EU EMA | Malignant Prostate Neoplasm | Treatment of prostate cancer. | approved | — | ema |
| Enzalutamide | US FDA | — | Efficacy supplement 2026-07-24 (see label) | approved | Jul 24, 2026 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2026-07-24 (see label) | approved | Jul 24, 2026 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2023-11-16 (see label) | approved | Nov 16, 2023 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2023-11-16 (see label) | approved | Nov 16, 2023 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2022-09-09 (see label) | approved | Sep 9, 2022 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2022-09-09 (see label) | approved | Sep 9, 2022 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2020-10-23 (see label) | approved | Oct 23, 2020 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer. ( 1 ) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Malignant Prostate Neoplasm | non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 ) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Malignant Prostate Neoplasm | metastatic castration-sensitive prostate cancer (mCSPC) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Nonmetastatic Castration-Sensitive Prostate Carcinoma | non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer (CRPC) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Malignant Prostate Neoplasm | metastatic castration-sensitive prostate cancer. ( 1 ) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2019-12-16 (see label) | approved | Dec 16, 2019 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2018-07-13 (see label) | approved | Jul 13, 2018 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2017-07-24 (see label) | approved | Jul 24, 2017 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2016-10-20 (see label) | approved | Oct 20, 2016 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2015-07-21 (see label) | approved | Jul 21, 2015 | openfda |
| Enzalutamide | US FDA | — | Efficacy supplement 2014-09-10 (see label) | approved | Sep 10, 2014 | openfda |
| Enzalutamide | US FDA | Malignant Prostate Neoplasm | non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 ) | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Malignant Prostate Neoplasm | metastatic castration-sensitive prostate cancer (mCSPC) | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer (CRPC) | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Nonmetastatic Castration-Sensitive Prostate Carcinoma | non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Malignant Prostate Neoplasm | metastatic castration-sensitive prostate cancer. ( 1 ) | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer. ( 1 ) | approved | Aug 31, 2012 | openfda |
| Flutamide | CA Health Canada | — | Marketed in Canada as FLUTAMIDE-250 (DIN 02239388) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 23, 2009 | Feb 22, 1999 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as FLUTAMIDE (DIN 02239045) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 25, 2016 | Dec 1, 1998 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as FLUTAMIDE (DIN 02238560) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 8, 1998 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as FLUTAMIDE (DIN 02230875) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 28, 2016 | Oct 31, 1997 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as PMS-FLUTAMIDE (DIN 02230104) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 4, 2025 | Feb 21, 1997 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as TEVA-FLUTAMIDE (DIN 02230089) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | Jan 16, 1997 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as FLUTAMIDE (DIN 02059673) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 31, 2014 | Dec 31, 1996 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as EUFLEX (DIN 00637726) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jun 1, 2015 | Dec 31, 1984 | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as PENTA-FLUTAMIDE (DIN 02233019) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018 | — | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as NU-FLUTAMIDE TABLETS (DIN 02239082) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled (Unreturned Annual)since Mar 28, 2018 | — | health-canada-dpd |
| Flutamide | CA Health Canada | — | Marketed in Canada as DOM-FLUTAMIDE (DIN 02230524) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Mar 26, 2025 | — | health-canada-dpd |
| Flutamide | US FDA | 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 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression. | approved | Sep 18, 2001 | openfda |
| Nilutamide | CA Health Canada | — | Marketed in Canada as ANANDRON (DIN 02221861) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Aug 3, 2024 | Aug 20, 1997 | health-canada-dpd |
| Nilutamide | CA Health Canada | — | Marketed in Canada as ANANDRON - TAB 100MG (DIN 02221888) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 22, 2003 | Aug 20, 1997 | health-canada-dpd |
| Nilutamide | CA Health Canada | — | Marketed in Canada as ANANDRON TAB 50MG (DIN 01989642) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 11, 1999 | Dec 31, 1994 | health-canada-dpd |
| Nilutamide | CA Health Canada | — | Marketed in Canada as ANANDRON TAB 100MG (DIN 00863904) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Sep 9, 1996 | Dec 31, 1992 | health-canada-dpd |
| Nilutamide | CA Health Canada | — | Marketed in Canada as ANANDRON TAB 50MG (DIN 00863890) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Sep 9, 1996 | Dec 31, 1992 | health-canada-dpd |
| Nilutamide | CA Health Canada | — | Marketed in Canada as ANANDRON TAB 100MG (DIN 01989650) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 11, 1999 | Dec 31, 1992 | health-canada-dpd |
| Nilutamide | US FDA | Malignant Prostate Neoplasm | Metastatic Prostate Cancer Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D 2 ). For maximum benefit, treatment with Nilutamide Tablets must begin on the same day as or on the day after surgical castration. | approved | Jul 15, 2016 | openfda |