NDA 208159, held by Btg Intl. Uridine Triacetate.
As of Nov 14, 2026, NDA 208159 (Vistogard), held by Btg Intl, was first approved by FDA on Dec 11, 2015, with 2 approved supplements and 0 published complete response letters.
VISTOGARD is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2015 | Original applicationNew indication · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vistogard10GM/PACKET · granule;oral | Uridine Triacetate | RxReference drug |
| Jun 7, 2016 | Supplement 2Manufacturing · Priority review | Approved | |
| Mar 29, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Dec 11, 2015 | Original applicationNew indication · Priority review | Approved |
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
