22 April 2020 - Terlipressin would be the first FDA approved treatment option in the United States for adult patients with hepatorenal syndrome type 1, a life-threatening condition, if approved.

Mallinckrodt today announced that the U.S. FDA has accepted for review the company's new drug application for terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1. 

On 17 March 2020 the company announced the completion of its rolling submission of the NDA for terlipressin. The FDA assigned a Prescription Drug User Fee Act target date of 12 September 2020.