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
WELCHOL — FDA Complete Response Letter (NDA 210895)
Issued to Daiichi Sankyo Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 24, 2018Application
NDA 505b1 • 210895
Product
WELCHOL
Company
Daiichi Sankyo Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 14 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 WELCHOL complete response letter
What does this complete response letter mean for WELCHOL?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Daiichi Sankyo Inc. on August 24, 2018.
What is NDA 210895?
NDA 210895 is the application under which FDA issued this complete response letter for WELCHOL to Daiichi Sankyo Inc.. It was reviewed by FDA Other. The letter is dated August 24, 2018.
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.