For hepatorenal syndrome with rapid reduction in kidney function. NDA 22231, held by Mallinckrodt Ireland. Terlipressin Acetate.
As of Nov 13, 2026, NDA 22231 (Terlivaz), held by Mallinckrodt Ireland, was first approved by FDA on Sep 14, 2022, with 2 approved supplements and 3 published complete response letters.
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Feb 18, 2022 | TerlipressinFacility Inspections | Approved |
| Sep 11, 2020 | Terlivaz (terlipressin)Clinical | Approved |
| Nov 4, 2009 | Lucassin (terlipressin)Clinical/Statistical, Product Quality, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TerlivazEQ 0.85MG BASE/VIAL · powder;intravenous | Terlipressin Acetate | RxReference drug |
| Jun 10, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Jan 9, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Sep 14, 2022 | 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
