Issued to Xeris Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 9, 2024Application
NDA 505b1 • 212097
Product
GVOKE PFS / GVOKE HYPOPEN / GVOKE KIT
Company
Xeris Pharmaceuticals, Inc.
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Bioequivalence and pharmacokinetics, Clinical efficacy and substantial evidence, 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.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Xeris Pharmaceuticals, Inc. on February 9, 2024.
NDA 212097 is the application under which FDA issued this complete response letter for GVOKE PFS / GVOKE HYPOPEN / GVOKE KIT to Xeris Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated February 9, 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.