Source facts
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls. 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
VESICARE LS — FDA Complete Response Letter (NDA 209529)
Issued to Astellas Pharma US, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 28, 2017Application
NDA 505b1 • 209529
Product
VESICARE LS
Company
Astellas Pharma US, Inc.
Review center
Other
Stage
Final Decision
Response due
December 31, 2020
Assyro regulatory brief
FreeWhat did FDA decide for VESICARE LS?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1Chemistry, manufacturing, and controls: 6 source-text matches.
Chemistry, manufacturing, and controls
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the VESICARE LS complete response letter
What does this complete response letter mean for VESICARE LS?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Astellas Pharma US, Inc. on August 28, 2017.
What is NDA 209529?
NDA 209529 is the application under which FDA issued this complete response letter for VESICARE LS to Astellas Pharma US, Inc.. It was reviewed by FDA Other. The letter is dated August 28, 2017.
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.