Treats hereditary orotic aciduria. NDA 208169, held by Btg Intl. Uridine Triacetate.
As of Nov 13, 2026, NDA 208169 (Xuriden), held by Btg Intl, was first approved by FDA on Sep 4, 2015, with 1 approved supplement and 0 published complete response letters.
XURIDEN is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria.
| Dec 2, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 4, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xuriden2GM/PACKET · granule;oral | Uridine Triacetate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
