MNK - Mallinckrodt Terlivaz gets FDA approval to improve kidney function in liver disease patients

• The U.S. Food and Drug Administration (FDA) approved Mallinckrodt's ( NYSE: MNK ) ( OTCPK:MNKPF ) Terlivaz (terlipressin) injection to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.
• HRS involves reduction in kidney function which occurs in people with advanced liver disease.
• Terlivaz is the first and only FDA-approved product indicated for this use, the U.K.-based company said in a Sept. 14 press release.
• Mallinckrodt added that the FDA decision, in part, was backed by data from a phase 3 trial called CONFIRM.
• Terlivaz comes with a boxed warnings which include, that the drug may cause serious or fatal respiratory failure, among other things, according to the company.

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