Issued to Zealand Pharma US, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 19, 2024Application
NDA 505b1 • 218828
Product
glepaglutide
Company
Zealand Pharma US, Inc.
Review center
CDERStage
Final Decision
Response due
December 19, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. 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.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Zealand Pharma US, Inc. on December 19, 2024.
NDA 218828 is the application under which FDA issued this complete response letter for glepaglutide to Zealand Pharma US, Inc.. It was reviewed by FDA CDER. The letter is dated December 19, 2024.
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.