cysteamine bitartrate

FDA Drug Profile — Cystagon

Drug Details

Generic Name
cysteamine bitartrate
Brand Names
Cystagon
Application Number
NDA020392
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
CYSTEAMINE BITARTRATE

Indications and Usage

1 INDICATIONS AND USAGE PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. PROCYSBI is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. ( 1 )