Issued to Vero Biotech, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 23, 2019Application
NDA 505b1 • 202860
Product
GENOSYL
Company
Vero Biotech, LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Safety and adverse events, Chemistry, manufacturing, and controls. 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 Vero Biotech, LLC on January 23, 2019.
NDA 202860 is the application under which FDA issued this complete response letter for GENOSYL to Vero Biotech, LLC. It was reviewed by FDA Other. The letter is dated January 23, 2019.
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.