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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. JAVYGTORTM (sapropterin dihydrochloride) tablets, for oral use. Initial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
JAVYGTOR (sapropterin dihydrochloride) 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
- 43598-096, 43598-096-30, 43598-096-04, 43598-096-05
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en