Posted by Michael Wonder on 13 Jun 2022
Mallinckrodt announces resubmission of terlipressin to the FDA for the treatment of hepatorenal syndrome
13 June 2022 - Mallinckrodt today announced the resubmission of the Company's new drug application to the U.S. FDA for the investigational agent terlipressin to treat adults with hepatorenal syndrome involving rapid reduction in kidney function, an acute and life-threatening condition for which there is currently no FDA approved treatment.
The resubmission follows ongoing discussions with the FDA resulting from a complete response letter received on 18 February 2022.
