Posted by Michael Wonder on 03 Mar 2020
Mallinckrodt initiates rolling submission of new drug application to the U.S. FDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1
2 March 2020 - Terlipressin would be the first FDA-approved treatment option in the United States for patients with HRS-1 if approved.
Mallinckrodt today announced it initiated the rolling submission of a new drug application to the U.S. FDA for terlipressin, an investigational agent being investigated for the treatment of hepatorenal syndrome type 1 (HRS-1), by submitting its clinical data package.
The company expects to complete the submission of the application in the coming months.
