sepiapterin
sepiapterin is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Sephience. Available dosage form: powder.
Drug Details
- Generic Name
- sepiapterin
- Brand Names
- Sephience
- Application Number
- NDA219666
- Sponsor
- PTC Therapeutics Inc.
- NDC Codes
- 2
- Dosage Forms
- POWDER
- Routes
- ORAL
- Active Ingredients
- SEPIAPTERIN
Indications and Usage
1 INDICATIONS AND USAGE 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. SEPHIENCE is a phenylalanine hydroxylase (PAH) activator 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. ( 1 )