Mallinckrodt Resubmitted NDA for Terlipressin Following Complete Response Letter

Mallinckrodt has resubmitted a New Drug Application (NDA) for its investigational drug, terlipressin, following a Complete Response Letter it received from the FDA in February.

The agency declined to approve the NDA for the drug because Mallinckrodt had identified a new third-party packaging and labeling facility that was not inspection ready.

Mallinckrodt said that issue was resolved in discussions with the agency.

Terlipressin is an analogue of vasopressin, an antidiuretic used for treatment of low blood pressure. The company is seeking the agency’s approval of the drug for treatment of adults with hepatorenal syndrome involving rapid reduction in kidney function.