nitisinone
nitisinone is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including ORFADIN, HARLIKU. Available dosage forms: suspension, tablet.
Drug Details
- Generic Name
- nitisinone
- Brand Names
- ORFADIN, HARLIKU
- Application Number
- NDA206356
- Sponsor
- Swedish Orphan Biovitrum AB (publ)
- NDC Codes
- 5
- Dosage Forms
- SUSPENSION, TABLET
- Routes
- ORAL
- Active Ingredients
- NITISINONE
Indications and Usage
1 INDICATIONS & USAGE Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.