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US FDA Advisory Cmte. To Evaluate Terlipressin's Clinical Outcomes, Risk Of Respiratory Failure

Executive Summary

Mallinckrodt's drug to treat hepatorenal syndrome met its primary endpoint of HRS reversal but FDA wants reassurance that this surrogate endpoint translates into a treatment effect on clinical outcomes. A greater incidence of respiratory failure in those receiving terlipressin "remains a significant safety concern," the agency says.

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