Issued to Genentech, Incorporated. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 23, 2020Application
NDA 505b1 • 214410
Product
XOFLUZA
Company
Genentech, Incorporated
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Genentech, Incorporated on November 23, 2020.
NDA 214410 is the application under which FDA issued this complete response letter for XOFLUZA to Genentech, Incorporated. It was reviewed by FDA Other. The letter is dated November 23, 2020.
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.