calcium, magnesium, potassium, and sodium oxybates

FDA Drug Profile — XYWAV

Drug Details

Generic Name
calcium, magnesium, potassium, and sodium oxybates
Brand Names
XYWAV
Application Number
NDA212690
Sponsor
Jazz Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
CALCIUM OXYBATE, MAGNESIUM OXYBATE, POTASSIUM OXYBATE, SODIUM OXYBATE

Indications and Usage

1 INDICATIONS AND USAGE XYWAV is a central nervous system depressant indicated for the treatment of: • Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1.1 ). • Idiopathic Hypersomnia (IH) in adults ( 1.2 ). 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. 1.2 Idiopathic Hypersomnia XYWAV is indicated for the treatment of idiopathic hypersomnia (IH) in adults.