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Mallinckrodt Announces Resubmission Of Terlipressin To FDA For Treatment Of Hepatorenal Syndrome

Published: 06/13/2022 12:02 GMT
(MNKKQ) - Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome.
Mallinckrodt Plc - Resubmission Follows Ongoing Discussions With FDA Resulting From a Complete Response Letter (crl) Received on February 18, 2022.
Mallinckrodt - in Two Weeks Prior to PDUFA Date of Feb 18, 2022, It Became Necessary to Identify a New Third-party Packaging and Labeling Facility.
Mallinckrodt - While Co Identified New Facility, FDA Inspection of Facility Could Not Be Completed by Feb PDUFA Date, Resulting in Receipt of Crl.