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These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral useKUVAN (sapropterin dihydrochloride) powder, for oral solutionInitial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
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.
- generic_name
- sapropterin dihydrochloride
- product_names
- SAPROPTERIN DIHYDROCHLORIDE, sapropterin dihydrochloride
- ndc
- 68135-300, 68135-300-02, 68135-301, 68135-301-11, 68135-301-22, 68135-482, 68135-482-10, 68135-482-11
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en