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# FDA Approves Mallinckrodt Kidney Drug
- URL: https://www.fdaweb.com/fda-approves-mallinckrodt-kidney-drug/
- Published: 2022-09-15T12:00:00.000Z
- Updated: 2026-09-14T17:59:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152755

FDA has approved Mallinckrodt’s [Terlivaz (terlipressin)](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2022/022231s000lbl.pdf?ref=fdaweb.com) injection for improving kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. The agency says Terlivaz is the first approved medication for this condition. HRS is most common in those with advanced cirrhosis and ascites, fluid buildup in the abdomen that is often related to liver disease, it says.

Approval was based on data from a double-blind [study](https://www.clinicaltrials.gov/ct2/show/NCT02770716?ref=fdaweb.com). “Twenty-nine percent of participants in the Terlivaz group had kidney function improvement compared to 16% of participants in the placebo group,” FDA says.

Because Terlivaz increases the risk of serious or fatal respiratory failure, FDA warns that patients with low oxygen in their blood should not start the medication. During treatment, patients should be monitored with a pulse oximeter, it adds.