nitisinone
Drug Details
- Generic Name
- nitisinone
- Brand Names
- HARLIKU, ORFADIN
- Application Number
- NDA209449
- Sponsor
- PENN PHARMACEUTICAL SERVICES LTD
- NDC Codes
- 5
- Dosage Forms
- TABLET, SUSPENSION
- 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.