Application Nr Approved Date Route Status External Links
NDA022181 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Kuvan ® 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). Kuvan Is To Be Used In Conjunction With A Phe-Restricted Diet. Kuvan 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). Kuvan Is To Be Used In Conjunction With A Phe‑restricted Diet. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sapropterin Dihydrochloride SAPROPTERIN DIHYDROCHLORIDE ZINC13585233

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