Posted from: Monday, October 05, 2015 - 04:19 PM - Present

Xuriden Approval for Treating Hereditary Orotic Aciduria

September 14, 2015 – The U.S. Food and Drug Administration (FDA) granted the first ever approval to Wellstat Therapeutics’ Xuriden (uridine triacetate) oral granules for the treatment of hereditary orotic aciduria (HOA). HOA is a rare metabolic disorder that has been reported in approximately 20 patients worldwide. People with this disorder may have blood abnormalities, urinary tract obstruction and developmental delays. Xuriden is a prodrug of uridine and provides four to seven times more uridine than oral uridine administration. Designated as an orphan drug, and granted priority review by the FDA; Xuriden was also granted a rare pediatric disease priority review voucher. Xuriden is approved as oral granules that can be mixed with food or in milk or infant formula. Xuriden should be administered daily. It will be available as orange-flavored granules in single-use 22g packets on 30-count cartons. The expected launch date for Xuriden is early 2016. 

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Last Updated Friday, October 18, 2019 - 02:11 AM.