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These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR™ (sapropterin dihydrochloride) powder for oral solution. Initial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
JAVYGTOR 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.
- generic_name
- sapropterin dihydrochloride
- product_names
- Sapropterin Dihydrochloride
- ndc
- 43598-162, 43598-162-11, 43598-162-30
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en