NDA 210951, held by Janssen Biotech. Apalutamide.
As of Nov 13, 2026, NDA 210951 (Erleada), held by Janssen Biotech, was first approved by FDA on Feb 14, 2018, with 15 approved supplements and 0 published complete response letters.
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. non-metastatic castration-resistant prostate cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2023 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 7, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2020 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2019 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 14, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Erleada60MG · tablet;oral | Apalutamide | RxReference drug |
| Erleada240MG · tablet;oral | Apalutamide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2026 | Supplement 24Labeling · Standard review | Approved | |
| Mar 5, 2026 | Supplement 21Labeling · Standard review | Approved | |
| Aug 2, 2024 | Supplement 16Labeling · Standard review | Approved | |
| Jul 9, 2024 | Supplement 17Manufacturing | Approved | |
| Dec 19, 2023 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Feb 17, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Nov 8, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Nov 8, 2022 | Supplement 9Labeling · Standard review | Approved | |
| Apr 26, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Sep 7, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 14, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Nov 20, 2020 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Sep 1, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Jul 10, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Sep 17, 2019 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 14, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
