Posted by Michael Wonder on 14 Sep 2020
Mallinckrodt receives a complete response letter from the U.S. FDA for terlipressin for the treatment of hepatorenal syndrome type 1
14 September 2020 - Company remains committed to working with FDA toward an approval for this important potential therapy.
Mallinckrodt today announced that the U.S. FDA has issued a complete response letter regarding the company's new drug application seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1.
The letter stated that, based on the available data, the agency cannot approve the terlipressin new drug application in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with hepatorenal syndrome type 1.
