Treats cataplexy or excessive daytime sleepiness (EDS). NDA 212690, held by Jazz. Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate.
As of Nov 13, 2026, NDA 212690 (Xywav), held by Jazz, was first approved by FDA on Jul 21, 2020, with 13 approved supplements and 0 published complete response letters.
XYWAV is a central nervous system depressant indicated for the treatment of:
| Aug 12, 2021 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jul 21, 2020 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xywav0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML · solution;oral | Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate | RxReference drug |
| Jul 28, 2025 | Supplement 19REMS | Approved | |
| May 21, 2025 | Supplement 17REMS | Approved | |
| Nov 18, 2024 | Supplement 16REMS | Approved | |
| May 22, 2024 | Supplement 15REMS | Approved | |
| Jan 16, 2024 | Supplement 12REMS | Approved | |
| Apr 4, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Aug 22, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Feb 9, 2022 | Supplement 9REMS | Approved | |
| Dec 9, 2021 | Supplement 8REMS | Approved | |
| Aug 12, 2021 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jun 23, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Feb 11, 2021 | Supplement 2REMS | Approved | |
| Feb 11, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Jul 21, 2020 | Original applicationNew active ingredient · 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
