Treats advanced prostate cancer. NDA 214621, held by Sumitomo Pharma Am. Relugolix.
As of Nov 13, 2026, NDA 214621 (Orgovyx), held by Sumitomo Pharma Am, was first approved by FDA on Dec 18, 2020, with 4 approved supplements and 0 published complete response letters.
ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer.
| Oct 18, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orgovyx120MG · tablet;oral | Relugolix | RxReference drug |
| Nov 4, 2026 | Supplement 15Labeling · Standard review | Approved | |
| Oct 8, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Oct 18, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Dec 18, 2020 | 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
