22 February 2022 - 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, an acute and life-threatening syndrome involving rapid reduction in kidney function for which there is currently no FDA-approved treatment.

Within the last two weeks, it became necessary to identify a new packaging and labelling manufacturing facility which meant that an inspection of the new facility by the FDA could not be completed by the PDUFA date. A satisfactory inspection is required before the new drug application can be approved. This is the only outstanding issue noted in the complete response letter, and it is important to note that there were no safety or efficacy issues cited.

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