Carglumic acid will be approved when ALL of the following are met:
- The patient has a diagnosis of ONE of the following:
- Acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS)
OR - Chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS)
OR - Acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)
AND
- Acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS)
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, nephrologist, metabolic disorders) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
AND - The requested dose is within FDA labeled dosing for the requested indication
Length of Approval: 12 months
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