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These highlights do not include all the information needed to use SEPHIENCE safely and effectively. See full prescribing information for SEPHIENCE. SEPHIENCE (sepiapterin) oral powder Initial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)-restricted diet.
- generic_name
- sepiapterin
- product_names
- SEPIAPTERIN
- ndc
- 60468-006, 60468-006-01, 60468-006-03, 60468-007, 60468-007-01, 60468-007-03
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en