Horizon Pharma plc receives Health Canada approval for Ravicti (glycerol phenylbutyrate) oral liquid for the treatment of urea cycle disorders in patients two years of age and older

21 March 2016 - Horizon Pharma  today announced that Health Canada has issued a Notice of Compliance (NoC) for Ravicti (glycerol phenylbutyrate) oral liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients two years of age and older with urea cycle disorders.

Last month Horizon announced that the Therapeutic Products Directorate of Health Canada had determined that Ravicti (glycerol phenylbutyrate) oral liquid is eligible for data protection as it is an "innovative drug" as defined by section C.08.004.1 of the Food and Drug Regulations. Based on the approval, Ravicti will be added to the Register of Innovative Drugs and receive data protection for a term of up to eight years from the date of the issuance of the NoC.

For more details, go to: http://ir.horizon-pharma.com/releasedetail.cfm?ReleaseID=961434

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Canada