pegvaliase-pqpz
Drug Details
- Generic Name
- pegvaliase-pqpz
- Brand Names
- Palynziq
- Application Number
- BLA761079
- Sponsor
- BioMarin Pharmaceutical Inc.
- NDC Codes
- 5
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- SUBCUTANEOUS
- 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 )