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sapropterin dihydrochloride

FDA Drug Profile — sapropterin dihydrochloride, ZELVYSIA, Kuvan

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 Sapropterin dihydrochloride powder for oral solution 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). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride powder for oral solution 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). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet. ( 1 )