Source facts
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
SUNLENCA — FDA Complete Response Letter (NDA 215974)
Issued to Gilead Sciences, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 28, 2022Application
NDA 505b1 • 215974
Product
SUNLENCA
Company
Gilead Sciences, Inc.
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 17 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the SUNLENCA complete response letter
What does this complete response letter mean for SUNLENCA?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Gilead Sciences, Inc. on February 28, 2022.
What is NDA 215974?
NDA 215974 is the application under which FDA issued this complete response letter for SUNLENCA to Gilead Sciences, Inc.. It was reviewed by FDA Other. The letter is dated February 28, 2022.
What happens after an FDA complete response letter?
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.