Federal Register Notice: FDA has determined the regulatory review period for Hyperion Therapeutics’ Ravicti is 2,126 days for extending a patent which claims the human drug product. Ravicti (glycerol phenylbutyrate) is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients two years of age or older with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. To view this notice, click here.