Mallinckrodt Gets CRL Regarding NDA For Terlipressin

(RTTNews) - Mallinckrodt plc (MNKKQ) said the 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. Mallinckrodt said, within the last two weeks, it became necessary to identify a new packaging and labeling manufacturing facility. An inspection of the new facility by the FDA could not be completed by the PDUFA date.

Steven Romano, Chief Scientific Officer at Mallinckrodt, said: "We remain committed to this critically ill patient population, who currently have no approved treatment option in the U.S for hepatorenal syndrome, and we believe that there is a path to approval in 2022."