Terlivaz FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2022.
FDA Approved: Yes (First approved September 14, 2022)
Brand name: Terlivaz
Generic name: terlipressin
Dosage form: Lyophilized Powder for Injection
Company: Mallinckrodt Inc.
Treatment for: Hepatorenal Syndrome
Terlivaz (terlipressin) is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.
- Terlivaz is thought to increase renal blood flow in patients with hepatorenal syndrome by reducing portal hypertension and blood circulation in portal vessels and increasing effective arterial volume and mean arterial pressure (MAP).
- Terlivaz is administered intravenously every 6 hours.
- Warnings and precautions associated with Terlivaz include serious or fatal respiratory failure, adverse reactions that may make a patient ineligible for liver transplantation if listed, ischemic events, and embryo-fetal toxicity.
- Common adverse reactions include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Development timeline for Terlivaz
| Date | Article |
|---|
| Sep 14, 2022 | Approval FDA Approves Terlivaz (terlipressin) for the Treatment of Hepatorenal Syndrome (HRS) |
| Jun 13, 2022 | Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome |
| Sep 14, 2020 | Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1) |
| Jul 15, 2020 | Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1) |
| Apr 22, 2020 | Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of New Drug Application for Terlipressin for Treatment of Hepatorenal Syndrome Type 1 (HRS-1) |
| Mar 17, 2020 | Mallinckrodt Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1) |
| Mar 2, 2020 | Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1) |
| Aug 15, 2019 | Mallinckrodt Announces Positive Top-Line Results from its Pivotal Phase 3 CONFIRM Trial of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1) |
| Mar 30, 2010 | Ikaria Acquires New Drug Application for Lucassin |
| Jun 12, 2009 | FDA Accepts Final Section of NDA Filing for Lucassin |
Further information
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