← FDA DRUG APPROVALS

FDA NDA · NDA212690

XYWAV

calcium, magnesium, potassium, and sodium oxybates

Sponsor: JAZZ

APPLICATION
NDA212690
TYPE
NDA
ORIGINAL APPROVAL
2020-07-21
LATEST ACTION
2025-07-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XYWAV · ReferencePrescription
CALCIUM OXYBATE 0.234GM/ML, MAGNESIUM OXYBATE 0.096GM/ML, POTASSIUM OXYBATE 0.13GM/ML, SODIUM OXYBATE 0.04GM/ML · SOLUTION · ORAL

Approval history

2025-07-28REMS · Supplement 19 — Letter ↗AP
2025-05-21REMS · Supplement 17 — Letter ↗AP
2024-11-18REMS · Supplement 16 — Letter ↗AP
2024-05-22REMS · Supplement 15 — Letter ↗AP
2024-01-16REMS · Supplement 12 — Letter ↗AP
2023-04-04Labeling · Supplement 11 · standard — Letter ↗AP
2022-08-22Labeling · Supplement 10 · standard — Letter ↗AP
2022-02-09REMS · Supplement 9 — Letter ↗AP
2021-12-09REMS · Supplement 8 — Letter ↗AP
2021-08-12Efficacy · Supplement 6 · priority — Letter ↗AP
2021-06-23Labeling · Supplement 5 · standard — Letter ↗AP
2021-02-11Labeling · Supplement 1 · standard — Letter ↗AP
2021-02-11REMS · Supplement 2 — Letter ↗AP
2020-07-21Type 2 - New Active Ingredient · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →