arimoclomol citrate

FDA Drug Profile — MIPLYFFA

Drug Details

Generic Name
arimoclomol citrate
Brand Names
MIPLYFFA
Application Number
NDA214927
Sponsor
Acer Therapeutics Inc.
NDC Codes
8
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
ARIMOCLOMOL CITRATE

Indications and Usage

1 INDICATIONS AND USAGE MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. ( 1 )