Carglumic acid
Drug Details
- Generic Name
- Carglumic acid
- Brand Names
- Carglumic acid
- Application Number
- ANDA213395
- Sponsor
- Navinta LLC
- NDC Codes
- 4
- Dosage Forms
- TABLET, FOR SUSPENSION, POWDER
- Routes
- ORAL
- Active Ingredients
- CARGLUMIC ACID
Indications and Usage
1 INDICATIONS AND USAGE Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. ( 1.1 ) Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. ( 1.1 ) 1.1 Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency Carglumic acid tablets for oral suspension is indicated in adult and pediatric patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency. Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.