Treats fascioliasis. NDA 208711, held by Novartis. Triclabendazole.
As of Nov 14, 2026, NDA 208711 (Egaten), held by Novartis, was first approved by FDA on Feb 13, 2019, with 1 approved supplement and 0 published complete response letters.
EGATEN is indicated for the treatment of fascioliasis in patients 6 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Egaten250MG · tablet;oral | Triclabendazole | RxReference drug |
| Feb 17, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Feb 13, 2019 | Original applicationNew molecular entity · 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
