Issued to Mallinckrodt Hospital Products IP Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 11, 2020Application
NDA 505b1 • 022231
Product
TERLIVAZ
Company
Mallinckrodt Hospital Products IP Limited
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Mallinckrodt Hospital Products IP Limited on September 11, 2020.
NDA 022231 is the application under which FDA issued this complete response letter for TERLIVAZ to Mallinckrodt Hospital Products IP Limited. It was reviewed by FDA Other. The letter is dated September 11, 2020.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.