Complete Response Letter for terlipressin a proposed treatment for hepato-renal syndrome
Mallinckrodt Plc announced that the FDA has issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS), an acute and life-threatening syndrome involving rapid reduction in kidney function for which there is currently no FDA-approved treatment.
Terlipressin is an investigational agent being evaluated for the treatment of HRS in the U.S., and its safety and effectiveness have not yet been established by the FDA.
Within the last two weeks, it became necessary to identify a new packaging and labeling 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 NDA can be approved. This is the only outstanding issue noted in the CRL, and it is important to note that there were no safety or efficacy issues cited.