Manages moderate to severe pain associated with endometriosis. NDA 210450, held by Abbvie. Elagolix Sodium.
As of Nov 13, 2026, NDA 210450 (Orilissa), held by Abbvie, was first approved by FDA on Jul 23, 2018, with 6 approved supplements and 0 published complete response letters.
ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2021 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 23, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OrilissaEQ 150MG BASE · tablet;oral | Elagolix Sodium | RxReference drug |
| OrilissaEQ 200MG BASE · tablet;oral | Elagolix Sodium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2025 | Supplement 11Labeling · Standard review | Approved | |
| Jun 5, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Feb 1, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2021 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 28, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Jul 23, 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
