sapropterin dihydrochloride
Drug Details
- Generic Name
- sapropterin dihydrochloride
- Brand Names
- sapropterin dihydrochloride, ZELVYSIA, Kuvan
- Application Number
- ANDA215534
- Sponsor
- NorthStar RxLLC
- NDC Codes
- 6
- Dosage Forms
- TABLET, POWDER, FOR SOLUTION
- Routes
- ORAL
- Active Ingredients
- SAPROPTERIN DIHYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE JAVYGTOR (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet. JAVYGTOR (sapropterin dihydrochloride) is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet. ( 1 )