Posted by Michael Wonder on 01 Dec 2015
Horizon Pharma plc receives European Commission approval for Ravicti (glycerol phenylbutyrate) oral liquid for the treatment of urea cycle disorders in patients two months of age and older
30 November 2015 - As Ravicti is a designated orphan medicinal product containing a new active substance, it will benefit from a period of 10 years of regulatory data/market protection with a possibility of extension to 11 years and a period of 10 years of orphan market exclusivity concurrently applied to each of the approved six sub-types of the UCDs.
For more details, go to: http://ir.horizon-pharma.com/releasedetail.cfm?ReleaseID=944591
