Issued to Fabre-Kramer Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 2, 2007Application
NDA 505b1 • 021164
Product
EXXUA
Company
Fabre-Kramer Pharmaceuticals, Inc.
Review center
Other
Stage
Final Decision
Response due
November 23, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls, Statistical analysis. 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 Fabre-Kramer Pharmaceuticals, Inc. on November 2, 2007.
NDA 021164 is the application under which FDA issued this complete response letter for EXXUA to Fabre-Kramer Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated November 2, 2007.
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.