Search Orphan Drug Designations and Approvals
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Generic Name: | glycerol phenylbutyrate | ||||||||||||||||
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Trade Name: | RAVICTI | ||||||||||||||||
Date Designated: | 04/27/2009 | ||||||||||||||||
Orphan Designation: | Maintenance treatment of patients with deficiencies in enzymes of the urea cycle | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Horizon Pharma USA, INc. 150 South Saunders Road Suite 400 Lake Forest, Illinois 60045 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | glycerol phenylbutyrate |
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Trade Name: | RAVICTI | |
Marketing Approval Date: | 02/01/2013 | |
Approved Labeled Indication: | Use as a nitrogen-binding agent for chronic management of adult and pediatric patients > or =2 years of age with urea cycle disorders (UCDs) who 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 (eg, essential amino acids, arginine, citrulline, protein-free calorie supplements). | |
Exclusivity End Date: | 02/01/2020 | |
Exclusivity Protected Indication* : | Use as a nitrogen-binding adjunctive therapy for chronic management of adult and pediatric patients at least 2 years of age with urea cycle disorders (UCDs) 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 (eg, essential amino acids, arginine, citrulline, protein-free calorie supplements). | |
2 | Generic Name: | glycerol phenylbutyrate |
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Trade Name: | RAVICTI | |
Marketing Approval Date: | 04/28/2017 | |
Approved Labeled Indication: | For use as a nitrogen-binding agent for chronic management of patients 2 months of age and older with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. | |
Exclusivity End Date: | 04/28/2024 | |
Exclusivity Protected Indication* : | For use as a nitrogen-binding agent for chronic management of pediatric patients > or =2 months and <2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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