What is the generic name?

SAPROPTERIN DIHYDROCHLORIDE

What is the Trade Name for SAPROPTERIN DIHYDROCHLORIDE?

Sapropterin Dihydrochloride

What are the Indications for SAPROPTERIN DIHYDROCHLORIDE?

• 1 INDICATIONS AND USAGE Sapropterin dihydrochloride tablets are 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 is to be used in conjunction with a Phe-restricted diet. 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‚Äë (BH4‚Äë) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride is to be used in conjunction with a Phe‚Äërestricted diet. ( 1 )

References: https://open.fda.gov/