Treats stable Wilson's disease. NDA 215760, held by Orphalan. Trientine Tetrahydrochloride.
As of Nov 13, 2026, NDA 215760 (Cuvrior), held by Orphalan, was first approved by FDA on Apr 28, 2022, with 0 approved supplements and 0 published complete response letters.
CUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2022 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cuvrior300MG · tablet;oral | Trientine Tetrahydrochloride | 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
