fosdenopterin hydrobromide

FDA Drug Profile — Nulibry

Drug Details

Generic Name
fosdenopterin hydrobromide
Brand Names
Nulibry
Application Number
NDA214018
Sponsor
Sentynl Therapeutics, Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
FOSDENOPTERIN HYDROBROMIDE

Indications and Usage

1 INDICATIONS AND USAGE NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. NULIBRY is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. ( 1 )