Posted by Michael Wonder on 02 May 2017
Horizon Pharma announces FDA approval to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to people with urea cycle disorders two months of age and older
1 May 2017 - Horizon Pharma today announced the U.S. FDA has approved its supplemental new drug application to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to people two months of age and older who have urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Ravicti initially was approved by the FDA in 2013 for adults and children as young as two years of age.
