NDA 212099, held by Bayer Healthcare. Darolutamide.
As of Nov 13, 2026, NDA 212099 (Nubeqa), held by Bayer Healthcare, was first approved by FDA on Jul 30, 2019, with 5 approved supplements and 0 published complete response letters.
NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). metastatic castration-sensitive prostate cancer (mCSPC). metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
| Jun 3, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 2022 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jan 7, 2021 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nubeqa300MG · tablet;oral | Darolutamide | RxReference drug |
| Sep 22, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Jun 3, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Oct 13, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Aug 5, 2022 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jan 7, 2021 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | 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
