Pegvaliase

FDA Drug Profile

Drug Details

Generic Name
Pegvaliase
Brand Names
N/A
Application Number
Sponsor
Boehringer Ingelheim RCV GmbH & Co KG
NDC Codes
1
Dosage Forms
LIQUID
Routes
N/A
Active Ingredients
PEGVALIASE

Indications and Usage

1 INDICATIONS AND USAGE PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. PALYNZIQ is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. ( 1 )