sodium oxybate

FDA Drug Profile — Lumryz, Xyrem, sodium oxybate

Drug Details

Generic Name
sodium oxybate
Brand Names
Lumryz, Xyrem, sodium oxybate
Application Number
NDA214755
Sponsor
Catalent Pharma Solutions, LLC
NDC Codes
15
Dosage Forms
FOR SUSPENSION, EXTENDED RELEASE, KIT, SOLUTION
Routes
ORAL
Active Ingredients
SODIUM OXYBATE

Indications and Usage

1 INDICATIONS AND USAGE Sodium Oxybate Oral Solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Sodium Oxybate Oral Solution 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 ).