Treats migraine with or without aura. NDA 212157, held by Scilex Pharms. Celecoxib.
As of Nov 13, 2026, NDA 212157 (Elyxyb), held by Scilex Pharms, was first approved by FDA on May 5, 2020, with 2 approved supplements and 0 published complete response letters.
ELYXYB is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ELYXYB is not indicated for the preventive treatment of migraine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Elyxyb25MG/ML · solution;oral | Celecoxib | RxReference drug |
| Nov 21, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 2Labeling · Standard review | Approved | |
| May 5, 2020 | Original applicationNew dosage form · Standard 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
