Issued to Organon, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 23, 2004Application
NDA 505b1 • 021164
Product
EXXUA
Company
Organon, 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, Bioequivalence and pharmacokinetics, Labeling, packaging, and proprietary name. 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 Organon, Inc. on June 23, 2004.
NDA 021164 is the application under which FDA issued this complete response letter for EXXUA to Organon, Inc.. It was reviewed by FDA Other. The letter is dated June 23, 2004.
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.