Issued to Zydus Worldwide DMCC. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 2, 2021Application
NDA 505b1 • 211566
Product
ZITUVIO
Company
Zydus Worldwide DMCC
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence. 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 Zydus Worldwide DMCC on September 2, 2021.
NDA 211566 is the application under which FDA issued this complete response letter for ZITUVIO to Zydus Worldwide DMCC. It was reviewed by FDA Other. The letter is dated September 2, 2021.
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.