diazoxide choline

FDA Drug Profile — VYKAT XR

Drug Details

Generic Name
diazoxide choline
Brand Names
VYKAT XR
Application Number
NDA216665
Sponsor
Soleno Therapeutics, Inc.
NDC Codes
3
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DIAZOXIDE CHOLINE

Indications and Usage

1 INDICATIONS AND USAGE VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). ( 1 )