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Horizon Pharma's Ravitchi (Glycerol Phenylbutyrate) Receives FDA Approval for Expansion of Age Range for in Patients with Urea Cycle Disorder (UCD)

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Horizon Pharma's Ravitchi (Glycerol Phenylbutyrate) Receives FDA Approval for Expansion of Age Range for in Patients with Urea Cycle Disorder (UCD)

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  • 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)
  Ref: Horizon Pharma | Image: WMA Consulting Engineers

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