Additional Relevant Details Horizon Pharma has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for RAVICTI® (glycerol phenylbutyrate) Oral Liquid to expand the age range for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two years of age to two months of age and older.RAVICTI is currently indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than two years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. The sNDA seeks to expand the approved age range for RAVICTI to include children as young as two months of age, and is based on a clinical development program including two clinical trials that enrolled 17 UCD patients between the ages of two months and two years.