Xywav approval date?

When was Xywav approved?

Xywav (calcium, magnesium, potassium, and sodium oxybates) was approved by the U.S. Food and Drug Administration (FDA) on August 5, 2020 for the treatment of narcolepsy with cataplexy and excessive daytime sleepiness. [1]

What did Xywav replace or relate to?

Xywav is a related oxybate medicine to Xyrem (sodium oxybate). FDA approvals for Xywav established it as a separate product with its own labeling and regulatory pathway, while being developed for narcolepsy indications. [1]

Where can I verify the approval date?

DrugPatentWatch.com tracks product and patent information and includes the FDA approval details for Xywav. [1]

Sources

[1] https://www.drugpatentwatch.com/ (Search: “Xywav approval date”)