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Hyperion Therapeutics Inc Receives Orphan Drug Exclusivity From FDA


Thursday, 2 May 2013 09:01am EDT 

Hyperion Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) notified the Company that RAVICTI (glycerol phenylbutyrate) Liquid has qualified for orphan drug exclusivity. The orphan exclusivity is for seven years from the date of the approval on February 1, 2013. RAVICTI Indications, Usage and Safety Information RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ two years of age with UCD that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements). The metabolite of RAVICTI, PAA, is associated with neurotoxicity at levels ≥ 500 μg/mL. If symptoms of vomiting, nausea, headache, drowsiness, or confusion are present in the absence of high ammonia or other intercurrent illnesses, reduce the RAVICTI dosage. Pancreatic insufficiency or intestinal malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely in these patients. Most common adverse reactions in 10% or more of patients are: diarrhea, flatulence, headache, nausea, vomiting, fatigue, decreased appetite, HA, dizziness, headache, upper abdominal (stomach) pain and rash. 

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25.02
0.4 +1.62%
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