Horizon Pharma's Ravitchi (Glycerol Phenylbutyrate) Receives FDA Approval for Expansion of Age Range for in Patients with Urea Cycle Disorder (UCD)
Shots:
- The expansion approval of age range for ravicti is based on the study assessing safety- efficacy and PK in UCD infants patients aged ≤ 2mos.
- The study demonstrated safety and efficacy in children younger than two months- with stable ammonia levels relative to pre-study enrollment
- Ravitchi (glycerol phenylbutyrate) is an oral nitrogen binding agent liquid- indicated for chronic management of patients with urea cycle disorders (UCDs)
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